The midth century was the golden age of natural product discovery. Scientists discovered ground-breaking drugs, like penicillin and tetracycline, from sources in nature. But as the search for natural products continued, pharmaceutical companies kept finding the same products over and over again. A prescription drug already in use for the treatment of high blood pressure could be effective against conditions such as Parkinson's, Alzheimer's, and Huntington's, in which toxic proteins build up in brain cells. Perkins Capital Management Inc. China now accounts for a significant share of revenues for most major multinational pharmaceutical companies and almost 40 percent of total glo Goodwin Biotechnology, Inc.
FSD Pharma Inc. The license went into effect on April 18, According to Alan Westwood, chief executive of Matoke, a company hoping to develop a new form of antibiotic, the issue of antibiotic resistance is one of the most troubling issues of our times. It is one of the biggest threats to human health. The world's biggest pharmaceutical companies are revealing prices of their prescription drugs on websites for the first time in a bid to stave off pressure from the Trump administration to make even more public disclosures.
The move by companies ranging from pharma giant Pfizer to biotechnology Pfizer and Eli Lilly and Company announced top-line results from a Phase III clinical trial of two doses of tanezumab in moderate-to-severe osteoarthritis OA of the hip or knee. The results were mixed, with the 5 mg dose meeting two of the three co-primary efficacy endpoints but missing on the pat Welcome to another dose of Dispensed, Business Insider's weekly healthcare newsletter!
Before heading out for the holiday weekend, I wanted to highlight some of the great work the healthcare team here has been pulling together.
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The entire Business Insider newsroom got together to compile a list CNN - For decades, though nobody was really sure why, April 20 has been the unofficial holiday for marijuana users and a joke by and about them. Now, though, it's also a reminder of how quickly marijuana is moving from illegal and a joke to a multi-billion-dollar legal business and a good time Cancer is among one of the leading causes of death in the world since many countries are burdened by the lack of access to adequate healthcare, which results in the high number of deaths. Researchers and scientists are constantly developing new, innovative medicines to effectively treat patients.
However, the cost to conduct clinical trials and then receive approval to commercialize a drug is absurdly expensive. This proof-of-concept study, published today in Science Translational Medi Locking a biochemical gate that admits fuel into immune-suppressing cells could slow tumor progression and assist the treatment of multiple cancers, says new research from the Wistar Institute, the University of Nebraska-Lincoln and others.
Published April 17 in the journal Nature, the study found e Advanced pancreatic cancer is often symptomless, leading to late diagnosis only after metastases have spread throughout the body. Additionally, tumor cells are encased in a "protective shield," a microenvironment conferring resistance to many cancer treatment drugs.
Now, Salk Institute res He leading agency and financial media network dedicated to the North American cannabis industry, announces the publication of an article covering biosynthesis and International Cannabis Corp. Biosynthesis is the process of manipulating simple substances to pr A biotech company using artificial intelligence AI for drug discovery, and the Drugs for Neglected Diseases initiative DND i , a not-for-profit research and development organization working to deliver new treatments for neglected diseases, today announced that promising drug-like compounds have Kintai is focused on leveraging the body's diverse signaling networks to pioneer a new class of Prec CellVax can now respond to the strong demand for optimal selection of models that represent the human disease best and is able to offer preclinical studies in large nonrodent species as well as diversified preclinical models or clinical trials.
Large animal models are essential for the development o The leading international association for operations research and analytics professionals, announced that Booz Allen Hamilton has been awarded the INFORMS Prize for their pioneering and enduring integration of operations research O. Alchem's molecule is the sole micronized digoxin available globally that resolves the challenge of micro dosage formulation and the long-term stability and impurity issues with this specialist heart drug.
Digoxin is commonly administered to treat various heart conditions including atrial f In recent weeks, tensions between the two camps have escalated, and some fights have even spilled into public view. In a high-profile tug of war, lawmakers hoping to strike an accord with the Trump administration have been forced to confront a faction pressing Democrats to instead pursue a bolder pr Christian Mielsch and Florian Seubert as new members of the Board of Directors and proposing them for election at the General Meeting of Shareholders to be held on 23 May The nomination is intended to add proven expertise in technology, tra The award-winning semantic technology company, today announced the launch of CENtree, an innovative, collaborative platform which revolutionises the way Life Sciences organisations manage and release ontologies.
Ontologies play a critical role in semantic enrichment, enabling unstructured scientific Both Diplomat Pharmacy Inc. We will contrast their risk, analyst recommendations, profitability, dividends, institutional ownership, earnings and valuation. Diplomat Pharmacy, Inc. Pharmacists should not sell cannabis-derived medical products over the counter OTC , according to pharmacy students at the Annual Professional Debate.
On Wednesday, Sen. Bernie Sanders I-Vt. Food and Drug Administration today issued a safety labeling change orderto Sprout Pharmaceuticals for their drug, Addyi flibanserin , that requires the company to revise important safety information that women and their health care professionals need to have when considering use of the dru Zogenix, Inc. The FDA determined th Alcon is officially a standalone company. The eye care specialist has officially spun out from Swiss pharma giant Novartis. Mayinglong hemorrhoid ointm Amazon's new Alexa upgrade offers some HIPAA-compliant skills—and some potential new opportunities for drugmakers that want to jump on the voice-activated AI platform.
Amazon announced six partners last week in its first HIPAA-compliant nod for the voice apps it calls "skills. Breast cancer is a rare disease in men, making it tough for drugmakers to conduct clinical trials. But Pfizer came up with a solution. The pharma giant scored a new nod Thursday for big-seller Ibrance in males, based largely on real-world evidence.
Along the way, regulators studied data from electro Jazz, Lundbeck and Alexion each struck deals with th Increasingly fraught Sino-American relations are beginning to have a real impact on the health sector, after it emerged that the health networking startup PatientsLikeMe is being forced to find a buyer after the Trump administration ordered its Chinese majority owner to divest its stake.
According t Alec Burkaloff, who pleaded guilty in a Boston courthouse in November on federal racketeer But some Spark investors still think the price is too low. So far, Spark investors have tendered o Novartis has placed its big bet in therapeutic radiopharmaceuticals wit AbbVie investors are calling for a separation of powers in the C-suite, citing Chairman and CEO Richard Gonzalez's outsized pay package and the company's "thicket" of Humira patents. A refrigerated container of drugs was rolling on the river last year when a supply chain mishap resulted in eight shipping containers falling like dominoes from a ship into the Elizabeth River in Virginia.
Now Heritage Pharmaceuticals wants reimbursement. The Eatontown, New Jersey-based drugmaker ha The polar vortex that brought bone-chilling temperatures to much of the United States earlier this winter highlighted a near constant concern — an inadequate supply of platelets at blood centers across the country. Platelets are essential for helping the body stop bleeds and are also excellent The trial is evaluating enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer who had previously received both platinum-based chemothera Cystic fibrosis drugmaker Vertex Pharmaceuticals was forced to destroy nearly 8, packs of its drug Orkambi after the medication had expired before they could be shipped to the United Kingdom due to a contentious pricing fight.
The government announced the creation of NHSX last month and there are now 11 days to go before the official launch said h Ablation of cardiac tissue is one of the most common ways of treating atrial fibrillation. Celgene has filed its highly anticipated oral MS drug ozanimod with the US regulator, more than a year after the FDA rejected it because of a bureaucratic foul-up. Around three years a Every five to ten years they have to be replaced in another invasive surgery that patients abhor and that put a high cost on the healthcare system. The cash injection will be used to support a positron emission tomography PET imaging techni Aldeyra Therapeutics, headquartered in Lexington, Mass.
The trial evaluated reproxalap topical ophthalmic solution in two different concentrations, 0. The trial met the primary end Brisbane, Calif. Thermo Fisher Scientific, based in Waltham, Mass. Brammer Bio is a contract development and manufacturing organization CDMO focusing on manufacturing viral vectors for gene and cell the When the Human Genome Project was completed, in , it opened the door to a radically new idea of health—that of personalized medicine, in which disease risk and appropriate treatment would be gleaned from one's genetic makeup.
As more people had their genomes sequenced, disease-related Novartis has finalized plans for the long-awaited spin-off of its Alcon eye care business, announcing that the new company will list on April 9. Exscientia K. As America continues to grapple with the opioid crisis, nonprofit advocacy group Public Citizen is calling for the U. Food and Drug Administration FDA to place a moratorium on the approval of any new opioid medications. Doctolib, the largest digital health service in Europe, has raised million euros in a funding round, valuing it at over a billion euros.
Merck KGaA, Darmstadt, Germany, and Pfizer discontinued a Phase III ovarian cancer drug trial after determining that the degree of benefit observed in the treatment during an interim analysis does not support the continuation of the trial. It was the second ovarian cancer trial the two companies col A team of researchers across The University of Manchester have shown that a new class of drugs are able to stop ovarian cancer cells growing. AstraZeneca continues to make the case for its Farxiga diabetes drug, highlighting a cardiology analysis that it hopes will convince more doctors to prescribe it in a highly competitive market.
March 18, - Dr. The approval is based on results from the phase II Washington D. Merck KGaA is doubling down on AI through a new collaboration agreement with tech firm Iktos, using its generative modeling technology to speed up the discovery and design of promising new compounds. Toronto: Canadian scientists have developed a kind of magnetic tweezer that can precisely insert a minuscule bead robot into a live human cancer cell, pointing to a new option for diagnosing and killing cancer.
The study, published in the journal Science Robotics, described the design in which a mag The college bribery scandal that is currently lighting up the media was brought to light by a Securities and Exchange Commission SEC investigation into a pharmaceutical pump-and-dump case. The scandal, dubbed Operation Varsity Blues, revolves around dozens of wealthy parents paying a college consu Diabetologists say nearly a third of-of their insulin dependent patients are now paying more for their daily Researchers at Indiana University have developed a blood test that could help more accurately diagnose post-traumatic stress disorder, or PTSD.
The study tracked more than veterans in over visits at the Richard L. New Delhi: Drug firm Zydus Cadila Wednesday said it has received final approval from the US health regulator to market Potassium Chloride extended-release capsules, used to treat or prevent low amounts of potassium in the blood.
Zydus Cadila said the newly-approved product will be manufactured at th Osiris makes medical products used to treat skin, bone and cartilage damage, with the bulk of its revenues coming from Grafix and St Food and Drug Administration on Tuesday approved a new generic of heart medicine Valsartan and said it prioritized the drug's review to help relieve recent shortage as manufacturers around the world have pulled the treatment from the market. Several drugmakers, including Teva Pharmaceut The City of Memphis has filed a federal lawsuit against a group of more than 20 opioid drug manufacturers and distributors, accusing them of fueling the addiction crisis plaguing the community, according to court records.
The lawsuit was filed in U.
Notes from a conversation with Terry Sejnowski, December 19, 2012:
District Court for the Western District of Tenne The opioid crisis came to the loan market last week, as the potential fallout from lawsuits weighed on manufacturers of the drugs cited as a root cause of the epidemic. The European Commission has adopted a Communication detailing actions to be taken to avoid the proliferation of pharmaceutical substances into the environment.
AstraZeneca has announced an immuno-oncology collaboration with US biotech Seres Therapeutics, which will focus on increasing understanding of the gut microbiome in order to increase the efficacy of cancer immunotherapy. The tie-up is based on preclinical and clinical evidence suggesting that the co The first findings to result from a collaboration between Seattle Children's Research Institute and Microsoft data scientists provide expecting mothers new information about how smoking before and during pregnancy contributes to the risk of an infant dying suddenly and unexpectedly before their A new biomarker that could be used to provide an earlier diagnosis for a life-limiting lung condition has been identified by researchers at the University of Bradford.
Pulmonary arterial hypertension PAH affects around 6, people in the UK and is caused by a narrowing of the arteries supplying b Sanofi has been hoping to secure approval from the U. Food and Drug Administration FDA for its dengue vaccine, but a mixed review from a panel of experts could sink the chances of a green light for the medication. The not-for-profit organization, the Pistoia Alliance, has announced new software that aims to make pharma labs work more efficiently, replacing handwritten experiment methods with digital documents. Bedrock Healthcare Communications has appointed Emily Howman to lead its scientific services team in a move designed to reinforce its core medical communications offering.
After Allergan reported that its late-stage adjunctive treatment for major depressive disorder failed to distinguish itself against placebo, hedge fund investor Appaloosa LP is again calling on the Ireland-based company to make some changes to its board of directors, including tapping a new chairman So in January , the Ipsen will be launching a new pre-filled syringe for its blockbuster rare disease drug Somatuline lanreotide in the EU.
The new design was based on several studies, involving patients, their caregivers, nurses and other healthcare professionals that aimed to inform and test enhancements to the exi Triple-negative breast cancer patients lack three common markers estrogen, progesterone, and HER2 making them unresponsive to targeted therapies. A team led by University of Chicago scientists may have found a new option for these patients, and it's one that involves combining two old FDA-approv Alnylam thinks it has strong enough clinical data for its gene-silencing drug for rare disease acute hepatic porphyria AHP , and plans to move ahead with regulatory filings in the US and Europe.
A new study conducted by researchers from Genentech and Roche shows first-time proof that artificial intelligence can detect the severity of diabetic macular edema, which is a leading cause of blindness. In its full-year results for , Merck KGaA said sales rose in by The Cambridge, Massachusetts, biotech—which was one of our Fierce 15 winners last year—says the new funding will be used to expand its pipe Although not completely clear why the drop may be related to a high percentage of serious adverse events observed in the trial.
Researchers at Saint Louis University have found that eating a Mediterranean diet can improve athletes' endurance exercise performance after just four days. In a small study published in the Journal of the American College of Nutrition, investigators found that participants ran a 5K six percent A Vertex triple-combination treatment for cystic fibrosis hit the mark in two Phase III trials, setting the stage for the company to secure approval for another treatment for the life-shortening genetic disease that affects approximately 75, people in North America, Europe, and Australia.
This mo Bristol-Myers Squibb announced its bid to acquire Celgene on January 3, However, the deal hit a snag. Wellington owns about an 8 percent stake in Bristol-Myers. Another BMS shareholder, Starboa Directive, the leading B2B and enterprise search marketing agency, has recently been honored as the number one B2B marketing and advertising service provider in Los Angeles, according to Clutch.
Clutch is a B2B research, ratings and reviews site that identifies leading IT and marketing service provi The new study was publ The blood-brain barrier is an important defense mechanism that prevents infections and contamination within the brain. It is also responsible for making it extremely difficult to get therapeutic drugs, including chemo agents, into the brain. Now researchers at Washington University in St. Louis have After five years at the reins, Mike Taylor will step down from his role as president and chief executive officer of Waltham, Mass. Steve Hoerter, the chief commercial officer of More carcinogens have been discovered in blood pressure medications, which has prompted another recall by the U.
Construction, factory, and farm workers, among others, tend to put a lot of strain on their backs. Aside fr UK-based medical communications group Lucid has made its first acquisition, adding creative and digital consultancy Bluedog to the fold. Indiana University researchers are advancing knowledge about how bacteria build their cell walls that could contribute to the search for new antibacterial drugs.
They have created a new tool to observe living cells in real time under a microscope. Results of the first human study of a capsule designed to replace injections of biologics have been announced, using an automatic pill designed by Silicon Valley-based Rani Therapeutics. Problems for the troubled Pfizer unit that makes EpiPen injectors for Mylan have opened on a new front. Attorney for the Southern District of New York is now digging into the issues of why Pfizer continued to produce pens after receiving dozens of complaints that many were failing during li Shares of Waltham, Mass.
One in four people in Western and Asian societies develop a build-up of fat in the liver as a result of an unhealthy diet. This disease - referred to as non-alcoholic fatty liver disease NAFLD - causes no symptoms initially but can develop into end-stage liver cirrhosis with limited treatment opti Researchers with the Institut Pasteur and several other institutions restored the hearing in adult mice with a specific congenital form of deafness using gene therapy.
Ella Balasa, a year-old from Richmond, Virginia, recently made the news when she was apparently successfully treated for a lung infection using a kind of virus called a bacteriophage. If traditional drug delivery were a type of painting, it might be akin to paintball. With good aim, a majority of the paint ends on the bullseye, but it also drips and splashes, carrying streams of paint across the target. If the drug needs to enter the bloodstream and circulate throughout your body Mosquitoes that landed on surfaces coated with the anti-malarial compound atovaquone were completely blocked from developing Plasmodium falciparum P.
Chan School of Public Health. The study showed that atov Mylan has reported lower than expected full-year earnings and forecasts, thanks partly to delays in its generic Advair approval and continuing problems at its US manufacturing plant. North America segment net sales were dow There were only four observa Pressed by lawmakers in the House of Represen A change to European rules on drug manufacturing that could benefit makers of generics and biosimilars is edging closer after lawmakers agreed on draft legislation that tweaks rules on export and manufacture of drugs that are off-patent outside the EU.
The draft of the so-called supplementary protec Exosomes are tiny vesicles that seemingly all the cells in our bodies produce. Initially, exosomes were thought to be a way for cells to expunge built-up trash, but over the past decade or so scientists have discovered that they seem to play an important role in regulating a variety of biochemical p It's not unusual for critics to challenge top drugmakers for price hikes on old drugs, but Novartis is contending with a different kind of pricing pressure from a Swiss shareholder activist group.
In this case, it's the company's move into ultra-expensive, one-time treatments that has cr The companies have created a big data project that creates a comprehensive database of Bernie Sanders, I-Vt. Cohen was testifying against the president in a much-anticipa Aurobindo pledged to resolve issues at a sterile manufacturing plant in India last year after an FDA inspection cited it for problems that could lead to contamination.
The FDA has made another trip to the key Aurobindo facility and once again found it lacking. The agency h A California jury decided Monday that two key patents protecting its Repatha cholesterol drug are indeed valid—and that puts Sanofi and Regeneron in a tough spot. The device is indicated as support for guidewires, helping to exchange guidewires, and for injection of radiopaque contrast agents, as well as the saline solution.
Fulminate sepsis is a dangerous condition, usually caused by a bacterial infection. The runaway behavior of the immune system in sepsis is still poorly understood. The trick is to diagnose it early and to use antibiotics to fight it off. These days it can take up to three days to diagnose sepsis, us The business, which makes equipment for researching, developing and manufacturing biopharmaceuti The decision sets Novartis up to test the RNA-targeting drug in phase 3 cardiovascular outcomes trial.
TQJ, formerly known The Swiss pharma has reached a deal to buy Spark in an all-cash transaction a The rotavirus vaccine may be pulling double duty; it not only protects young children against a potentially life-threatening rotavirus infection but may also reduce their likelihood of developing type 1 diabetes.
What to expect? High political theater, for one thing, as Republicans and Democrats both take their shots. But don't dismiss the event as mere grandstanding, analysts say. GE Biopharma includes a wide-range of dealings, including the development and sale of medical instrum The FDA is hoping to help the industry take a leap toward what was once pure science fiction: interfaces that link brains and computers, allowing a person to directly control devices with their thoughts.
To promote the development of a new generation of fully integrated implants, the agency publishe Shares of Opiant Pharmaceuticals fell in trading Thursday and continue to slide in premarket trading this morning after the company announced its Phase II trial evaluating a naloxone nasal spray for the treatment of bulimia nervosa failed to meet primary endpoints and will discontinue the program. Bayer is taking on myths about intrauterine devices IUDs in a new two-product ad campaign. The first-ever campaign featuring both the Mirena and Kyleena branded IUDs recently began as Bayer looks to not only explain what the levonorgestrel-releasing IUDs do but also impart basic knowledge about IU A trio of health policy analysts from the University of Pennsylvania and the University of California has published a Policy Forum piece in the journal Science calling for more stringent rules for the introduction of AI medical applications.
Diabetes researchers have long believed that the disease starts when the immune system attacks insulin-producing beta cells in the pancreas. But that theory never made much sense to Anil Bhushan, Ph. So he and a team of Performing a lab-quality test for many infectious diseases, particularly viral ones, is difficult in remote regions.
Much lab equipment requires some kind of infrastructure, including clean rooms, trained staff, and money. Mendelian will use the grant from Innovate UK to get a specialized screening system for ra With a Brexit deal still out of sight, there have been intensified warnings in the UK about potential disruptions to medical supplies that could follow a no-deal scenario. One government minister has said that a no-deal Brexit could disrupt medicines supplies to the UK for at least six months becaus This significant action is aimed at bringing nonprescription, over-the-counter OTC sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options.
Among its provisions, the Pfizer is moving rheumatoid arthritis patients to a lower dose of its blockbuster inflammatory diseases pill Xeljanz in a clinical study after a safety signal emerged in the trial of patients at high risk of cardiovascular events. A Janus kinase inhibitor class drug, Pfizer has produced Xeljanz as a Now, Vermont's congressman is zeroing in on a specific class of diabetes medicines that he says have become far too expensive: insulin.
Peter Welch introduced a bill on Nexus Pharmaceuticals, Inc. US biotech Vical is planning another round of job cuts after deciding to abandon its antifungal drug VL, its last remaining clinical-stage asset. The San Diego company only started the phase II trial of VL last year but says a slow uptake of patients into the trial, coupled with a need to Fentanyl is a powerful form of opioid given to patients who are suffering from severe pain.
The medication is about times more powerful than morphine. A new study shows that a large number of patients who should not have received something so powerful were still prescribed the drug. Trial data has suggested that upadacitinib, a JAK1-selective inhibitor, is more effective at tre In the seventeenth century, Hungarian Countess Elizabeth Bathory bathed in the blood of young women she murdered in order to sustain her beauty. Blood, albeit more freely given, continues to be an attractive tool for some who want to stave off the effects of age.
Individuals have been using plasma i Could a drug used to treat tapeworms be effective at treating a type of cancer?
Latest World News Stories on SPi for Monday 23rd September 2013
Researchers in Singapore think they are on the right track in demonstrating just that. Shares of France-based Inventiva have plunged more than 45 percent after the company reported that its experimental treatment for a rare autoimmune disease failed to hit primary and secondary endpoints in a mid-stage trial.
The combination of anti-PD-1 therapy Keytruda with tyrosi For millions of people across the globe, cholesterol has become a significant health issue. It also turns out that cholesterol can be a problem for some cancer cells. New research coming from Rockefeller University reveals that a rare tumor type is unable to synthesize cholesterol, which is somethin A new map of newborn babies' brains offers details of structure that will provide a new reference for researchers studying both typical brain development and neurological disorders. Using noninvasive, minute magnetic resonance imaging MRI scans, researchers have revealed some of the complex The drug was approved by the U.
Food and Drug Administration Roche has finally won NICE backing for the use of Perjeta pertuzumab to prevent early-stage HER2-positive breast cancer from recurring after surgery, at the third attempt. The new draft guidance means that the HER2 inhibitor can be given as an adjuvant therapy to people with early-stage HER2-posit Following international concern and outrage over a gene-editing treatment of human embryos in China, the World Health Organization WHO is taking action.
On Thursday, WHO announced it was assembling a panel of experts to form an advisory committee to develop global standards for the governance and High cholesterol could be a risk factor in the development of motor neuron disease, according to a study of genetic data by UK scientists. Cash cow Tecfidera has been pumping out blockbuster sales as Biogen plows ahead with pricey Alzheimer's trials and scouts for new pipeline assets. But what if those sales took a big hit early next year, instead of eight years later?
That's the threat from a Mylan challenge at the U. HiberCell focuses Despite nearly a century of research, researchers have so far failed to develop an oral form of insulin that would allow patients with diabetes to avoid multiple daily injections. The FDA has published new premarket guidance on efficient development and review of combination products, which often combine drugs or biologic medicines with a device.
In a statement, the FDA referred to the technologies such as digital pills from Proteus Digital Health, which track when patients t GlaxoSmithKline has been in the midst of a significant reshaping to focus on pharmaceuticals, particularly a renewed interest in oncology treatments. Products based on artificial intelligence should be regulated like drugs, and those that are deemed unsafe should be removed from the market, according to a new report. The fun The case dates back to a December lawsuit Bayer filed aga As biosimilar competition to Herceptin ramps up, Roche is looking to bolster its position in HER2-positive breast cancer with a new indication for Kadcyla.
The most recent is a complaint filed Jan. Many older adults who have major surgery experience postoperative delirium in the days after their operations. Previous research has suggested that closely monitoring the brain during surgery and making adjustments to protect the brain from too much anesthesia could reduce the risk of postoperative About 10 percent of breast cancer cases and 15 percent of ovarian cancers can be traced back to a flaw in one of these genes.
A class of drugs known as PARP inhibitors was de The decision paves the way for European approval, which usually follows a positive opinion from the CHMP within a few months. Ajovy is one of a g Scientists have shed light on a biological process that helps the production of healthy cells, which may aid the understanding of neurological diseases and other conditions. Researchers examined a housekeeping mechanism which removes faulty proteins as they form. This process, which is common to man UC San Francisco researchers have for the first time transformed human stem cells into mature insulin-producing cells, a major breakthrough in the effort to develop a cure for type 1 T1 diabetes.
Replacing these cells, which are lost in patients with T1 diabetes, has long been a dream of regenerat Novo Nordisk has said it is accelerating launch preparations for its new diabetes pill semaglutide, after investing in a voucher that will allow a fast review of the drug in the US.
The FDA grants priority reviews for drugs that it considers to be a significant improvement over available therapies f As lawmakers in Congress are exploring potential price-lowering options for prescription drugs, Department of Health and Human Services Secretary Alex Azar is floating a proposed rule to lower the prices and out-of-pocket expenses by encouraging manufacturers to pass discounts to patients instead of Drug shortages can occur for a number of reasons.
The Pharmaceutical Research and Manufacturers of America PhRMA lists the most common as changes in clinical practices, inventory practices of wholesalers and pharmacies, raw material shortages, changes in hospital and pharmacy contractual relations BD is releasing its new Nano pen needle designed for achieving consistent depth during subcutaneous injections, particularly for diabetic patients on insulin.
Intramuscular injections can occur when a patient applies too much force too many of the existing injection devices. The new BD Nano compensa The PharmaMar subsidiary failed to link the siRNA eye drops to improved scores on scales of ocular pain and corneal staining compared to artificial tears. Sylentis advanced tivanisiran in Sanofi, Novo Nordisk, and Eli Lilly have faced years of scrutiny over insulin prices, but their responses haven't satisfied two Democratic lawmakers who this week kicked off a fresh investigation into pricing for the products. The probe comes as drug pricing creates daily headlines in Washington Shares in Allergan fell after the company said it had swung to a loss in the last quarter of and forecast revenues below analyst expectations.
If there's any doubt, just look at the crowd of somethings in its newly launched TV ad: Young people exaggerate their facial expressions surprised, embarrassed or laughing with no noticeable frown lines or forehead wrinkles. Senate Finance Committee and the House Oversight Committee started hearings on Tuesday, January 29, focused on dealing with high drug prices. In the Finance Committee hearing, chair of the committee, Sen.
Chuck Grassley, R-IA , began by saying tackling high prescription drug prices was a p Will it be the drug that will actually break the string of more than drug failures? Today, Roche announced tha Lyndra Therapeutics, based in Watertown, Mass. Celgene has struck another collaborative deal, even as the large pharmaceutical company is in the process of being folded into the operations of its new owner, Bristol-Myers Squibb.
Takeda Pharmaceutical announced that its vaccine for dengue fever hit its primary efficacy endpoint in its Phase III clinical trial. Dengue fever affects as many as million people annually, according to the U. It is caused by one of four relate Leukemia drug Imbruvica snagged another approval from the U. The approval of the c It affects children and adult The majority of its successful drugs are in primary care and heart medicine, like Lipitor atorvastatin for cholesterol, Lyrica pregabalin for neuropathic pain and fibr The device helps to train the walking gait of people who have s The device can perform whole-body scans using both imaging modalities at the same time.
The system is expected to be used The California-based company, which allows customers to test their own DNA via mail, will now be able to tell its users whether they have the two most common genetic varia NICE has recommended digital cognitive behavioural therapy CBT should be used as a first-line treatment for children and young people with mild depression.
The hold comes just nine months after the agency lifted a clinical hold on a different prog In October, Minnesota Attorney General Lori Swanson filed a lawsuit against three of the biggest insulin manufacturers over price gouging claims. The Commission has approved the drug for the treatment of children with cystic fibrosis C Translate Bio had been hoping that it would initiate clinical trials for its rare liver disease treatment asset MRT this year. However, that hope has been delayed after the U. This morning, Lexington, Mass. There are a number of biomarkers identified that show a tendency toward the disease, such as ApoE, but not definitive tests.
Researchers with the German Center for Takeda could be considering selling some emerging-market drugs in a bid to cut debts following its merger with the Shire that completed earlier this month, according to a press report. Immunotherapy's promise in the fight against cancer drew international attention after two scientists won a Nobel Prize this year for unleashing the ability of the immune system to eliminate tumor cells.
But their approach, which keeps cancer cells from shutting off the immune system's power Patients with Parkinson's disease are treated with levodopa, which is converted into dopamine, a neurotransmitter in the brain. In a study published on 18 January in the journal Nature Communications, scientists from the University of Groningen show that gut bacteria can metabolize levodopa into A new survey has revealed confusion amongst the UK public on how to maintain a healthy lifestyle, suggesting the NHS has a long way to go to meet its goal of more disease prevention.
Researchers have taken a step closer to understanding the body's response to opioid painkillers such as morphine and fentanyl, which could lead to the development of safer opioid drugs. Opioids are a class of powerful painkillers used to treat moderate to severe pain. They act on the nervous sys The rate of incidence of infection by Naegleria fowleri in the U.
Novartis and Oxford University have begun a partnership that will attempt to use artificial intelligence to predict how patients will respond to new and existing treatments for inflammatory diseases such as multiple sclerosis MS and psoriasis. Researchers with American University have identified genetic factors that lead to squamous cell carcinoma, a form of skin cancer. They published their work in the journal Oncogenesis. Squamous cell carcinoma is the second most common form of cancer in the U.
A whistleblower alleged in a page complaint that dubious transactions amou Telehealth firm Tyto Care has secured additional funding to help with the launch of its technology allowing for remote medical examinations. This follows a rejection by the agency, requesting more d Shares of Illinois-based Aptinyx have plunged more than 67 percent in premarket trading after the company announced its mid-stage treatment for painful diabetic peripheral neuropathy failed to show statistical significance. A University at Buffalo psychologist has published a neuroimaging study that could help develop tests for early identification of dyslexia, a disorder that affects 80 percent of those diagnosed with difficulties reading, writing and spelling.
Tasks which require audiovisual processing are especially The notorious legacy of OxyContin continues to be a major black mark against Purdue Pharma. And that mark is only getting worse as a court case against the opioid manufacturer has revealed company officials used deceptive marketing practices to boost sales of the drug. Documents in a Massachusetts c Pfizer is finally closing on approval of its rare disease therapy tafamidis in the US, several years after it first reached the market in Europe. Shares of Alameda, Calif.
It was previously approved for the treatment of patients with advanced renal cell carcinoma. The approval came despi Persistent drug shortages have become dangerous and costly, the American Hospital Association says, forcing staff to use drugs with which they have less experience and that are sometimes more expensive. The past year proved to be a big one for the U.
The partial government shutdown has entered day 24 and the pharma and medtech industry is beginning to feel the impact even more, particularly as the U. On Monday, California-based Aimmune Therapeut Researchers at the University of Washington have developed a smartphone app that can detect if someone is experiencing an opioid overdose. The app uses sonar to monitor the breathing rate of a user, which it can do from up to three feet away, to assess if someone is experiencing an overdose. So far, Brain surgery is a complicated business, requiring utmost precision when excising tumors and other maladies.
BrainCarta, a Dutch firm, is showing off its Elonav technology that uses functional magnetic resonance imaging fMRI scans to create maps of lesions and provide helpful analysis about the ne The two companies were involved in pate National Safety Council analysis reveals trends that worsen the odds of dying accidentally.
For the first time in U. The odds of dying accident Like cartographers completing a map, investigators have identified multiple new subtypes of the most common childhood cancer research that will likely improve the diagnosis and treatment of high-risk patients. Jude Children's Research Hospital scientists led the study, which appears as an ad As the partial government shutdown enters its 21st day, tying it for the longest U.
Most noticeably for pharma and biotech, the partial shutdown has brought a halt to some of the operations of th Artificial intelligence and machine learning company InveniAI has joined with Kyowa Hakko Kirin to harness the power of technology for drug discovery. The companies are the latest to use AI and machine learning to make the drug development process more effective. In this case, Kyowa Hakko Kirin will One of the key immune regulatory proteins is interleukin 2 IL It has used in treating cancer and autoimmune disease but has toxic side effects that limit its use.
The increase in opioid prescriptions for people over the past decade may have been paralleled by an increase in opioid prescriptions for pets, according to a study from researchers at the University of Pennsylvania's Perelman School of Medicine and the School of Veterinary Medicine. The findings EUSA already markets two oncology drugs and is seeking to build its presence in the rare disease market with Sylvant, which has been approved in the US since to treat mu Certain types of hormone replacement therapy HRT could lead to an increased risk of venous thromboembolism VTE , a new study has suggested.
HRT is used to prevent a range of symptoms experienced by many women during the menopause, such as hot flushes and night sweats. The study, by researchers fr Swiss pharma giant Novartis has found itself at the center of a legal battle that could determine if the company engaged in a research project that was a kickback in disguise. Former Novartis executive Min Amy Guo has alleged that in , the company initiated a study of breast cancer drug Afinitor For the production of drugs, pesticides, and smartphone displays, most of the processes are cost-intensive and generate a large amount of waste.
The results were published Patients with cystic fibrosis are often infected by Pseudomonas aeruginosa, a bacterium that infects the lungs and prevents breathing, often causing death. Spoiled food is a global problem and people end up sick all the time. Modern methods of detecting spoiled food include smelling it, looking for moldy spots, and arguing with your spouse whether a given item is ready to be thrown in the trash. Researchers at Fraunhofer Institute for Optronics, System Also known as sickle cell pain crises, VOCs are unpredictable and extremely painful events that can lead to Takeda has officially taken over the Shire in a deal that could re-establish the trend for mega-mergers in big pharma.
The merger was approved yesterday in a court hearing in Jersey, where the Shire was officially based, although it was listed on the London Stock Exchange and domiciled in Ireland fo Takeda, years old, is now a top 10 international drug company. The entire deal began in March , with Takeda expressing an interest in buying the Shire. Once it was Barrett raised eyebrows last month when she announced her decision to leave Novartis after less than a year in charge of its oncology unit, but Last year was the biggest ever for digital health investment, according to a report that has been tracking the market since the beginning of the decade.
According to the report by Startup Health Insights, investment in digital health has increased fold since In , funding for digital hea The trial evaluated UGN mitomycin gel for installation for the non-surgical treatment of low-grade upper tract urothelial cancer UTUC. Of the 71 patients in the trial, 61 have been That deal was scheduled to wrap in , but the revision adds two clinical-stage bispecific antibodies to the collaboration.
The revision lets Regeneron ho Last week Takeda announced three new research collaborations in immuno-oncology Engaging in repetitive and ritualistic behaviors is part of typical child development.
However, behaviors that develop into obsessive and compulsive symptoms OCS may represent a red flag for serious psychiatric conditions. Selecta Biosciences, based in Watertown, Mass. The company believes that the cuts, along with a reprioritization of its pipeline, will decrease its yearly cash burn by 19 percent. At its third-quarter X-Chem Inc. Days ahead of the J. Morgan Healthcare Conference, Germany-based BioNTech extended its three-year-old collaboration with Sanofi as the companies look to co-develop the first cancer immunotherapy candidate for solid tumors.
CD39 is the enzym Sanofi has walked away from a four-year-old alliance with US biotech MyoKardia, handing back rights to three drugs for heart disease. The decision comes ahead of data readouts for two of the clinical candidates — mavacamten and MYK — within the next 12 to 24 months and comes as Sanof Microneedles are designed to infuse medications transdermally through the skin and relatively painlessly during clinical applications. In a recent study, Richa Mishra and her colleagues developed a new technique to convert polymer films into a fracture-resistant glassy form of carbon to develop mi The visual system is probably the best-understood part of the brain.
Over the past 75 years, neuroscientists have assembled a detailed account of how light waves entering your eyes allow you to recognize your grandmother's face, to track a hawk in flight, or to read this sentence. But a new stud BioXcel is a clinical-stage biopharmaceutical development company utilizing novel art Under the settlement and license agreement, Neos has granted Teva the rig Actemra, marketed as RoActemra in the EU, is approved for immunology Histology is used to identify structural details of tissue at the microscale in the pathology lab, but analyses remain two-dimensional 2D as they are limited to the same plane.
Nondestructive 3D technologies including X-ray micro and nano-computed tomography nanoCT have proven validity to unders A new study looking at the share of cancers related to obesity finds an at least 1. The proportion of cancer cases that could be attributable to excess body weight ranged from a high of 8. We know a good meal can stimulate the release of the feel-good hormone dopamine, and now a study in humans from the Max Planck Institute for Metabolism Research in Germany suggests that dopamine release in the brain occurs at two different times: at the time the food is first ingested and another on Parasitic protozoa called trypanosomes synthesize sugars using an unexpected metabolic pathway called gluconeogenesis, according to a study published December 27 in the open-access journal PLOS Pathogens by David Horn of the University of Dundee in the UK, and colleagues.
The authors note that this Acorda Therapeutics can breathe a bit easier. Warren argues that the generic drug system was designed to promote competition, which With the holidays upon us, along with the end of and the beginning of , the U. Food and Drug Administration FDA squeezed some target action dates into the last weeks and beginning of the new year.
As it turned out, these appear to be a mixed bag of extensions, resubmissions and suppleme Reuters: SUN. A pair of law firms representing the city recently filed a lawsuit in Middlesex Superior Court seeking damages from a range of major A tiny fingernail sensor has been worked up that monitors diseases and movement disorders. IBM Research tells their prototype story in a December video. The IBM team designed the tiny fingernail sensors to help clinicians detect and monitor the progression of disease via AI analysis and grip strengt Emergency medical personnel in Alameda County, California, use a screening process for determining whether to "medically clear" patients experiencing psychiatric emergencies before transporting them.
They identify patients who are at low risk for medical emergencies and take them directly With the majority of U. Programming Red Blood Cells to Carry Drugs A new startup looks to tackle hard-to-treat genetic disorders and diseases through genetically engineered red blood cells. The sensor offers the potential to quickly determine the severity of eye injuries at accident sites and remote areas. Ready or Not: Patient-Centered Device Development Is Here How can medical device developers incorporate patient preference information into their device designs and studies?
Why the Future of Disease Diagnosis Needs Engineers Engineers are needed to build new diagnostic devices to truly get at the cause of disease, says pioneering cellular biologist Jamey Marth. Google's Ambitious New Healthcare Biz Is Hiring Google's foray into the life sciences has grown into a sister spin-off company, with details continuing to come out about new technologies in the works. How Electronics Could Revamp the Humble Bandage A stretchy, adhesive bandage that makes use of temperature sensors and LED lights could be the world's first "smart band-aid.
Life sciences and health are the most active areas for investment at Google Ventures. What startups in that industry did the venture arm of Alphabet fund in ? Alector Name Collective Health Na Editas Medicine Name PatientPing N Zephyr Health. Spruce Name Here are the technolog A life sciences regulatory expert details trends you need to know, like localization and increased inspection.
Recent results of an EHR satisfaction survey poll nearly active users of the nine main EHR vendors across nine metrics including interoperability with medical devices. An Implantable LED to Take Your Pain Away A new flexible, biocompatible optogenetic device could help researchers better understand the neurological basis of pain, and So what's next? Medtronic to Outpace Industry Growth in Emerging Markets Emerging markets growth has been somewhat slower in medtech overall but Omar Ishrak expects Medtronic to buck that trend. The agency hopes to further improve device approval timelines while simultaneously safeguarding patients.
Solid-State Batteries Make for Smaller Medical Devices and Fewer Procedures Solid-state batteries, which are small, efficient, long-lasting, and capable of being recharged remotely, offer advantages for medical devices. It could take years before transcatheter mitral valve replacement truly hits the market, an analyst in the space is warning.
Why Healthcare Needs to Be Destroyed to Be Saved A medical futurist called for seismic shifts in healthcare to make it more efficient, transparent, and customer friendly, arguing that technologists should play a leading role in driving that change. Google Files Patent for Surgical Laser Technology A recently published Google patent describes a laser ablation device with an active tracking system that allows the laser to work even when a patient is moving.
Outlined in the warnings include problems related to duodenoscopes, reprocessed flexible bronchoscopes, and cybersecurity. The Medtech Industry Can't Hide from Security Flaws The medical device industry should more thoroughly consider the security ramifications of wireless technology in next-gen medical devices, according to a prominent security researcher. In a game of Chutes and Ladders among medtech's top companies this year, some of the industry's biggest names rose while others fell down in the ranks.
Want to Get Funded? Don't Forget Your IP Intellectual property may not be the most sexy topic to an entrepreneur with the next killer idea for a product, but without it, the idea will die a quick, penniless death. And the Lines Continue to Blur Between Device and Pharma Pharma companies are working with makers of FDA-cleared digital devices to gather information about adherence and prove that drugs work if taken regularly. How to Choose the Right Springs for Your Medical Device Picking a spring with the proper action, material, and feel can be critical to the success of a medical device.
While the techno While it has received international media attention, details of its plans remain scarce. The rate that technological breakthroughs are being developed continues to increase at breakneck speed, leading to seismic shifts in how people interact with technology on a daily basis. It is thus vital to ensure that developers of new technologi Medtronic Recalls Nearly , Pacemakers The medical device company reports that a battery problem in one of its pacemakers could interfere with normal device function.
A recent trip to Sweden, a hub of modular design, inspired this engineer to reflect on the pros and cons of modular design for medical devices. Top 10 Biomedical Engineering Schools by Salary Engineering is one of the most handsomely rewarded academic disciplines and, engineering continues to be the highest-paying major at the baccalaureate level. Biomedical engineers' compensation is competitive with the pay offered by many other engineeri Indian Government Scrutinizing Price of Medical Devices After allegations arose that multinational device makers were inflating maximum retail price of products, the Indian government has asked them to submit price details.
Data Breaches are a Costly Threat to Healthcare data breaches in the first six months of the year alone are straining the healthcare industry and putting a huge financial burden on it. MIT researchers used sophisticated mathematical equations to turn an off-the-shelf depth sensor, such as a Microsoft Kinect, into an biomedical imaging tool. And Another One Flies the U. Chris Newmarker. It apparently isn't working. The Medtech OEM's Guide to Contracting for Services It's important to ensure you have the correct terms in contracts for services before you sign on the dotted line.
It bonds well to a wide variety of substrates, including metals, composites, glass, ceramics as well as many types of rubber and plastics. The system has The American Medical Association is asking for a ban on direct-to-consumer advertising of prescription drugs and devices, but how realistic is it in the era of consumerization of healthcare.
It may be sensationalized, but the argument that many networked medical devices are relatively insecure is correct. Pfizer's pending buy of Allergan will reportedly cost it three times as much. Pfizer, however, is also dropping hints that it plans on breaking up its busi Jude Medical now has an FDA-approved spinal cord stimulation system that can be programmed with an iPad mini. And Philips has started selling its app-based ultrasound Lumify system--on a s Here are the three that came in on top.
Hackers Could Hold Medical Devices Hostage Next year, hackers will could begin threatening the lives of people with implantable devices according to a prediction by a tech market research firm. How to Design a 'Tricorder' That Could 'Hear' Cancer Stanford University researchers think they are four to five years away from a handheld, cancer-detecting device. From leadless pacemakers that can fit inside the heart to ultrasound devices that run off smart tablets, new medical devices continue to hit the market.
Even if FDA did have such authority, would it put it to use? Ishrak earlier this year also. Orchid Acquires Cam Bioceramics Coating Facility in Suzhou, China - Expands Coating Capability Holt, MI - Orchid Orthopedic Solutions Orchid , a worldwide leader in design and manufacturing for the orthopedic and medical device industry, is pleased to announce it has signed an agreement to acquire the Cam Bioceramics coating facility and Adoption of Drug-Coated Balloons Set to Increase Drug-coated balloons will be used more often in treating periperal artery disease in the U.
How to Minimize Vendor and Supplier Disputes in Medtech It is paramount for medical device companies to ensure standard purchase and supply documents address key requirements, legal terms, and specifications. How to Power Bioelectronics with Light Scientists out of China propose the use of a light-driven device that can power bioelectronic implants through the use of near-infrared rays and flashing light pulses.
Is the U. While the United States has traditionally been a global leader in the medical device field, Europe appears to be gaining ground--at least in terms of the major medical device companies based there. Learn what two experts say you can do in person during an inspection to avoid receiving Form observations or a warning letter.
If it looks like a duck, swims like a duck, and quacks like a duck, then it's probably a duck. While that "duck test" may be true for fowl, determining how medical devices are used in patients is a trickier subject. Alarm Problems Can Contribute to Deaths and Injuries Creating an effective medical alarm may sound straightforward on the surface, but it is anythin Contaminated Endoscopes the Top Health Tech Hazard Contaminated endoscopes and in particular, duodenoscopes, are the ECRI Institute's top health tech hazard for , following a year of news about infectious bacterial outbreaks and ineffective reprocessing practices.
Executives at the medical device giant have had high hopes for the Watchman heart device. But proposed CMS guidelines could limit Medicare coverage. SMCX ,e. Startup vs. Plugging unauthorized devices into those ports can cause an array of pr GE Finds Alternative to Weapons-Grade Uranium for Medical Imaging Medical imaging institutions in the United States may land a domestic source of the isotope that makes many scans possible, made with lower-strength uranium than the diminishing overseas supply.
Improper Cleaning of Flexible Endoscopes Can Spread Superbug Infections Few other medical device problems received as much attention in the press in This time, the paper says Safeway executives are severing ties. Theranos claims the report is defamatory. Top 5 Medical Device Dangers to Avoid in While faulty alarms continue to be a perennial risk, several of the other top medical device technology risks cited in ECRI's annual roundup of health technology hazards have gotten relatively little recognition.
Now, Apple chief Tim Cook is saying that future iterations of the Apple Watch won't have medical functionality either, but stated that it may produce "ad Humanizing Implantables: The 'Invisible' User Experience Today's implanted medical devices hold the potential to support wellbeing and proactively address preventable diseases in a more meaningful way than wearables ever could. But there are some glaring problems--including the "creepy factor" of implan Marie Thibault.
How Medical Device Makers Can Encourage Patient Engagement A Deloitte survey finds that patients are becoming more involved in their healthcare, but the different consumer demographics mean device companies must devise unique strategies to encourage more patient engagement. Here's how device makers can get in The Pfizer-Allergan deal could be three times bigger. Intuitive Surgical has sold more robots in the U. Does the company need to build a case around cost effectiveness any more? How the Robots Apocalypse Could Affect Medtech "We are facing a paradigm shift which will change the way we live and work," proclaims a recent report on robotics from Bank of America, which touches on the technology's potential to disrupt healthcare and manufacturing.
Unmet Needs: Inspiration for Medtech Inventors Physician inventors discuss what they see as the greatest unmet needs in pediatrics, cardiology, gastroenterology, and more. How Lasers Are Creating Cutting-Edge IVD Laser cutters with extremely small tolerances are playing an important role when it comes to creating microfluidics for lab-on-a-chip devices. Before your product goes to market, you have to know that it is safe and that you've analyzed and mitigated every risk possible.
Small Budget? Tips for Generating Reimbursement Data Gathering enough of the right kind of data needed to secure reimbursement coverage is a big challenge that looms larger for medical device makers with a limited budget. Here are creative tips for tackling the reimbursement challenge. Phillips-Medisize Completes 33, sq. Laser Microfabrication Takes on Diagnostic Consumables: Part 2 This article explains how lasers compare to traditional methods for fabricating diagnostic consumables.
The firm's founder Elizabeth Holmes is now vowing to be more forthcoming with data. Much of the recent controversy swirling around the company is related to avoidable regulatory Now, a venture firm launched by Burrill is chargin Top Doc: Wearables Solve a Problem Called December Top physicians are showing deep skepticism for wearables and the impact they can have on healthcare. A look at just how long it takes innovative devices to get to market via various regulatory pathways.
POC testing is supported by continuo Justice Department claimed that hundreds of hospitals across the country implanted implantable cardioverter defibrillators into people--and billed Medicare--when they should have been waiting. Could the crackdown curtail use of ICDs? Healing Broken Bones with Biodegradable Implants Recent findings suggest a new synthetic biodegradable material could help heal bones in patients with orthopedic injuries.
Obamacare is Coming into Sharper Focus Lofty ideals like empowering patients, accountable care, and the need to disrupt healthcare as we know it are starting to sound a lot more down to earth. Here's a timeline of how they got there. New Low Pressure Stopcocks with Rotating Male Luer Lock from Qosina Qosina is pleased to announce the addition of three new low pressure stopcocks - , in inventory and ready for immediate delivery.
Crafting a Reimbursement Strategy An executive explains how a small medical device company created and executes a successful reimbursement strategy. How to Avoid Exponentially Escalating Costs with Design Controls Medical device companies that identify quality problems early on can prevent product development costs from spiraling out of control, while also laying the groundwork for design verification and design validation.
Medical Device Alarms: A Delicate Balancing Act Too many medical device alarms are akin to crying wolf; too few could neglect to alert clinicians of an emergency. Feds Open Investigation into Valeant's Contact Lens and Drug Practices The Federal Trade Commission is investigating whether Valeant Pharmaceuticals International has gained a monopoly on the market for one of the main components of rigid contact lenses. Last month, House Democrats filed for a subpoena for documents that Bringing a ConsumerMed Device Home A design expert offers advice on designing "ConsumerMed" products for home use, including important considerations for training, patient input, ease-of-use, and connectivity.
Heard About Theranos? Now Medtronic is questioning the validity of those patents with the Patent Trial and Appeal Board of the. New Plastics Adapt to Changing Medical Needs Medical device manufacturers today demand plastics that are stronger, lighter, and more durable than ever before. The technology formed the basis for the company CardioInsight, which was Now, the company has announced that a fire has hit one of its manufacturing facilities, Regulatory Divisions Pressured by More Demands and Cost Cuts Regulatory affairs professionals have the mounting pressures of revised regulations, more PMAs, IDEs, and change requests to contend with, but don't have the higher headcounts or larger budgets to match.
Was Medtronic Right About St. Jude Medical cuts its revenue expectation for its novel congestive heart failure management device. Expandable or telescopic spinal implants for anterior cervical corpectomy can be compared to a car jack--when they Shocking Mental Disorders Into Submission Neurologists begin to explore targeted electrical brain stimulation to treat various mental disorders including obsessive compulsive disorder and even depression.
Supreme Court will decide whether Stryker Corp. Brain-computer interface technology as a way to bypass spinal injuries -- permitting paralyzed patients to move their limbs through the use of an implant in the brain. Collecting Reimbursement Data Alongside Clinical Data Is the Smart Road to Market Waiting to consider reimbursement until after your device has secured regulatory approval can be expensive and time-consuming.
Theranos Turns to Silence as Controversy Unfolds The curious case of Theranos raises questions not only about the former media darling but also about the rules that allowed it to share so little data with government regulators. What to Know about China's Fast Track Approval Process Even if you're at a non-Chinese company, you can still take advantage of the China Food and Drug Administration's fast track approval process for innovative medical devices.
An expert dispels common misconceptions about the process. How Hackable Are Medical Devices? As greater wireless functionality is incorporated into medical devices, the risk of security problems increases. Laser Microfabrication Takes on Diagnostic Consumables: Part 1 Advances in laser technology is leading to a wave of progress in diagnostic instruments.
New Exoskeleton Suit Aims to Help The Elderly Remain Active An international team of researchers have developed a portable robotic exoskeleton device that could serve as tool to help elderly patients remain active. The exoskeleton could make it easier for them to take walks, lift, and carry objects, and im A Bit There are real, practical concerns regarding digital health that will need to be ironed out before adoption can take place, says a well regarded cardiologist.
Now the company is seemingly under attack, facing tough scrutiny from both FDA and several press outlets--most notably the Wa There Will Be Blood Diagnostics startup Theranos has been wowing investors and healthcare observers with its goal to disrupt the blood-testing industry, but now its core technology and practices are being questioned.
What Is Disruptive Innovation and Why You Can't Afford to Ignore It For those of us in the medical device industry, attempting to predict when and where disruptive innovation will happen, can be baffling. Here are some pointers on how to identify what it is and how to actually create disruptive medical products. California Medtech Layoffs Approach Medical device companies--including some big names--have laid off nearly workers in California since July, according to a report by that state's Employment Development Department.
Fraud Allegations Surround Spinal Device Greenlit by FDA Spinal implant firm NuVasive recently received k clearance for a spinal implant for cervical corpectomy, marking the first time that the agency had approved or cleared a medical device for this intended use. One of the predicate devices used Bard Arundhati Parmar. This is a recognition of the advertisement that achieved the highest readership respons The Neverending Search for Brain-Inspired Chip Technology Scientists continue to make progress in the field of neural-inspired computer chips, which could ultimately lead to the development of novel neural networks and improve the treatment of traumatic brain injuries.
Here are tips on how to put the right quality system in place. Help us narrow down the group to five finalists. Problem Worries involve breast implants that Brazilian contract manufacturer Silimed made for Sientra. Jude Medical's. ThermaPress is the newest addition to the Thermex Thermatron line of heat sealing systems.
This thermal press system is designed for welding, sealing, and bonding thermoplastic materials not compatible with radio frequency RF or are too large for so Getting Started on Medical Device Cybersecurity Tackling cybersecurity in medical devices can be intimidating, leaving manufacturers overwhelmed and wondering where to start. Find out what the 10 largest companies in the space are doing, including highlights from Transcatheter Cardiovascular Therapeutics TCT in San Fran It came down to three words: trial and error.
From automated anesthesia systems to apps that promise to detect skin cancer, the use of artificial intelligence for clinical applications is steadily growing by the day, leaving observers to wonder what the role of clinicians will be in the years to Here are six reasons why. A biomarker of inflammation, it provides minute incubation and three-second reading time with an assay range Twelve analytes can be performed simultaneously.
Patented XCR-detection chemistry combines with a reagent system that uses rapid sample preparation and amplification to deliver rapid results. CEO Bill Olson says his tech Biocompatibility Is Dead, Long Live Biocompatibility According to Mike Drues, mere biocompatibility is just a description for a material that can be implanted in your body without k Boston Scientific Reveals Its Interest in Mitral Valve Replacement Boston Scientific has invested in an Israeli mitral valve replacement company since , but only revealed it on Thursday after pumping new money in it.
A young Maryland company has zinc-carbon flexible batteries in development that are safer next to the skin. Philips Hooks Up with Amazon to Host Medical Data in the Cloud The Netherlands-based tech giant continues to break down the traditional boundaries between the medical and consumer sectors.
Regulatory Tips for IoT Device Developers It's predicted that more and more device makers will add connectivity to medical devices. Here are some regulatory factors to consider as the Internet of Things sweeps the medtech industry. A new report from Evaluate Medtech shows how the medtech market is evolving, which companies will dominate, and which market segments will command the most revenue.
Expect that to change. A company's culture is paramount to its success at innovation. What are those unwritten rules that define a company and how can they be recreated to encourage innovation? New Formlabs 3-D Printer Takes on Medical Prototyping Formlabs officials think their new Form 2 stereolithographic 3-D printer could enable better medical device prototyping. Jude's menu of heart failure devices and services. Tips for Getting Your Device into a Hospital Trying to get your new medical device picked up by a major hospital?
Here are some insider tips for getting a foot in the operating room door. Why Device Designers Need to be Subversive To innovate at large companies, proponents of user-centered design need to go off the radar and develop a solution that meets the needs of the business while delivering something management never could have imagined. How to Make Flexible Electronics Stick Skin interface and adhesives present a major design opportunity for flexible electronics pioneer MC10 and others.
Top Orthopedic Firms and Trends From to The orthopedic industry will likely see some significant changes over the next few years. Here are some of the key trends facing the industry, and a brief overview of which companies are leading now, and which are projected to lead in Wearables Must Answer the 'So What? While the report also Blurred Lines: Big Pharma's On-Again Off-Again Relationship with Medtech The boundaries between the traditional drug and medtech realms are gradually eroding, being redrawn, and then eroding again.
And perhaps no other company understands the weight of that comm This new area of healthcare was created A New Cathode Material Lays Groundwork for Sodium-Ion Batteries Researchers from the University of Texas believe they have identified a novel safe and sustainable cathode material that could serve as the basic structure for the world's first commercially viable sodium-ion battery. FDA Warns St. Jude Medical's Atlanta facility have been addressed, the company says. What the Future Looks to Life Sciences Instrument Makers A recent survey of life science instrument makers and users were given the opportunity to select the technologies that could most benefit their industry.
Respondents also weighed in on key trends, including how they are dealing with regulatory Creative or Fraudulent? Based on history, it was probably Excellent Service by Stepping Back? CDRH is getting high marks for excellent customer service, but at the same time, some stakeholders say their concerns are met with what they feel are dehumanizing, automatic responses.
FDA Sends St. Move to 3. A world leader in the medical device testing industry, Nelson Labs is a microbiology testing and consulting services organization serving medical device, pharmaceutical, tissue, and life Telesis Technologies, Inc. Is Apple Developing a Smart Ring? A newly filed patent application suggests that the high tech giant is at least considering the possibility.
Nominate Medtech's Supplier of the Year Know a medical device and diagnostic industry supplier that went above and beyond this year? Nominate them for Medtech Supplier of the Year. Who Will Be the No. The U. One medtech veteran explains how traditional medtech manufacturers can benefit, even thrive, as a result of mHealth data. Keeping Up With Advances in Electronics Technological advances are opening up a whole new world for medical electronics designers.
Kenmode Expands Metal Stamping Capabilities with New Tech Center Kenmode has opened a 20,square-foot Tech Center for the rapid development and prototyping of new precision metal stampings. Nanoparticles Masquerading as Blood Cells Boost Drug-Delivery Precision Nanoparticles disguised as human platelets could open the door for targeted drug treatments for cardiovascular disease and various bacterial infections. The technique is expected to gre Medtech executives charged in two high-profile criminal cases are making the argument that FDA is squelching their free speech.
Here are seven recent cases to make the headlines. Device Makers Take Note: Cyber Attacks Are Already Hitting Healthcare Find out why some medical device manufacturers aren't adequately protected against cyber attacks and what companies can do to increase cybersecurity. Medtronic has been gobbling up companies and technologies in the past 15 months and the pace may quicken further.
What companies could be in its radar?
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A Biomimetic Dental Material As Strong As Tooth Enamel Swiss scientists have developed a technique that enables them to imitate miniature geometries found in biological composites with teeth and seashells. The breakthrough could ultimately lea If I were to tell you it's important to understand a problem before you start trying to solve it, you might reply with something like "nice one, Einstein".
How a Doctor Saved a Child with a MacGyver Medical Device A robotic surgeon got creative rigging together ordinary objects into a nebulizer when a child suffered an asthma attack on a transatlantic flight. Medical device and diagnostic companies have traditionally offered higher-than-average salaries and growth prospects, but is medtech still a good industry in which to stake your career? Some women are less suitable for the Essure device, according to an FDA panel, which examined thousands of complaints over the past decade. Check out all the major changes here.
AdvaMed Makes it Official CEO is Leaving Stephen Ubl, who has led the medical device industry's largest and most influential lobby group, is jumping ship to lead a pharma trade association. The new capability allows Scapa Healthcare to offer its strategic business partners an expansive range of skin friendly turn-key solu It turns out manmade silk that is stronger than steel is closer than we think.
Got Patient Care Ideas? The certification encompasses the production, assembly, and quality control processes of wire and cable. ISO is the leading quali Company Run by St. The recent film Ex Machina could serve as a warning for the unforeseen consequences associated with future medical technology. How Self-Driving Cars Can Steer Medical Devices to Success Medical device engineers can take lessons from the development of automated driving and apply them to the quest for closed-loop devices for diabetes, neurological disorders, and more.
How Makers Could Change the Medtech World Medical device innovation is being democratized--at least for a handful of applications including prosthetics and diabetes monitoring technology. Preparing for the Next-Generation of Healthcare Monitoring AirStrip made waves earlier this month when it debuted its Apple Watch-compatible fetal monitoring technology. This is the next generation of monitoring.
According to. Convicted Murderer Drops Suit Against Boston Sci Ramona Winebarger, who had been convicted of murdering her first husband in , has given up her legal fight against Boston Scientific. The medical device company had planned to enter the murder conviction into evidence in the trial, arguing that it Former St. Video: How to Pick the Best Ozone-Fighting Materials While extreme environments have the capability to pose serious threats for seals and O-Rings, one of the first design considerations for engineers should be the effects of ozone. How much exposure will rubber have to this powerful atmospheric oxidizing These catheters are used The idea behind the new app is to put information and community at the fingertips of diabetes patients.
How Philips Is Planning Mobile Health Success A string of announcements this year show Royal Philips seeking to turn its situation around through major plays in mobile health and overall innovation. Robotics Firm Sets Its Sights on Wheelchairs and Forklifts A company known as 5D Robotics wants to bring the field of smart robotics to manufacturing, medical technology, transportation, and other sectors.
The Technologies That Are Helping Paralyzed People Walk In the past couple of years, there have been a number of technological breakthroughs that have enabled paralyzed people to walk again with support. How Metrology Is Solving Its Shadow Puppet Problem For decades, many engineers have measured the accuracy of manufactured parts using a method bearing a certain resemblance to the method kids use to make shadow puppets appear on a wall.
How to Get Doctors to Embrace Next-Gen Technology An orthopedic surgeon explains what it will take to get widespread physician adoption of advanced technologies such as computer-assisted surgical navigation and surgical robots. One chart shows the reality is rapidly changing.
Connected, Data-driven Care is What It's All About Qualcomm Life's purchase of Capsule, a medical device integration and clinical data management company, underscores that the future of healthcare lies in connected, data-driven care. But in a few instances, devices have experienced malfunctions that threaten patients. Here are some scary medtech recalls. Direct Flow Medical explores the next generation of transcatheter aortic valve replacement devices made from polymers and completely free of metals.
The company says that the all-plasti Here are five highlights from the Minneapolis conference and expo. Starkey Fires 4 of Its Top Executives There are more questions than answers for now when it comes to privately held Starkey Hearing Technologies Eden Prairie, MN letting go of its president and three other top executives. Empirical Evidence Belies Survey Findings on Patent Licensing Criticizing the methodology of a recent survey that led to the conclusion that patent licensing doesn't mean innovation.
Exports a Growing Opportunity for U. Medtech Firms An international trade specialist with the U. Commercial services offers medtech companies advice on selling their products overseas. This is a recognition of the advertisement that received the highest readership response, Read on to find out which CEOs received the most total compensation. A Game Plan for Systematic Innovation The secret to developing a game-changing medical device is that it demands a methodical, rather than chaotic, product development process.
Last month, researchers released a prototype for a new wireless communication technique that sends magnetic signals through the human body, leveraging its natural magnetic waves. The technology could offer a more secure way to communicate informat Starks Stepping Down from St. Investigation Takes Aim at C. Bard Device Marie Thibault. Did C. A former C. Bard regulatory affairs specialist tells NBC News that she did not sign an application for a blood clot filter she thought was problematic. And yet the signature appears to be there. The company describes her claims as "flatly untrue. New Graphene Alternative Discovered A international team of researchers have used a computer simulation to predict the existence of a new carbon material known as "phagraphene.
Philips Is Making a Big Mobile Health Play The Dutch multinational is unveiling a series of health tracking programs that use Philips devices, apps, and cloud-based data analysis. Why Making Devices Easy-to-Use is Not So Easy While many companies believe they are focusing their development efforts on more intuitive solutions for the end user, few are succeeding. How Innovation Got One Man Killed: A Cautionary Tale Coming up with a breakthrough innovation isn't enough; you have to prove its worth, as one 19th century doctor tragically learned.
How to Cook Up Continuous Glucose Monitoring Retention Continuous glucose monitors are evolving to better service people with diabetes, but those without diabetes could also benefit from CGM technology. What's needed to make CGM accessible to a wider patient population? Making Mini-Lap Mainstream Mini-laparoscopic surgery is gaining favor among thought leaders in surgery.
Find out why some experts believe "mini-lap" should be used more frequently. Manufacturer Follows Device Hub To New Market Interplex Nascal worked with a medical company to design and manufacture their new product to meet their fast paced timeline. They were harsher on the agency than our regulatory experts, but you may be surprised by the issue for which they gave FDA high marks.
The New Medtronic Is Beating Expectations Medtronic is hearing some warm words from experts after reporting on results of the first quarter of its new fiscal year post-Covidien merger. Large and mid-sized medtech companies have had their eyes on emerging markets for a while now, but even the world's biggest medtech company is dealing with a difficult question. FDA consent decree. Sterimed, a world leading supplier of renewable-resource based packaging solutions to the medical device industry, launches its new website www.
Abbott Resorbable Stent Fares Well in Japanese Study Abbott has announced that, in a one-year clinical trial, its fully dissolving Absorb heart stent performed similarly to the company's Xience drug-eluting stent. Medical device makers that have facilities outside the United States and use foreign suppliers are still being scrutinized by FDA.
An expert weighs in on the specific challenges device manufacturers face today. This is something I get asked about often when mentoring new entrepreneurs, so I put together a Google Steps Up Its Fight Against Diabetes Google's focus on diabetes technology is getting clearer as it unveils a growing number of collaborations with companies specializing in treating the disease. Look to the past, says Bill Betten. Medtech Startups Making Waves in Medtech startups have it tough. Even if your business manages to secure funding, there are still regulatory, reimbursemen Trends in Medical Electronics Design and Miniaturization Embedded component assemblies are helping medical device designers bring down the size of their products.
Jamie Hartford. The first half of the year was marked by seismic shifts. For in The Rise of Contract Development in Medtech As they wrestle with evolving consumer needs, medical device firms are turning towards contract firms that can both help design their products and develop them. Ximedica's recent acquisiti One man thinks he has a solution to the problem of patient compliance.
Big Medtech Acquisitions You Need to Know The past week saw so many large medtech acquisitions, it was hard to keep track. Here are the highlights. Medtech companies are slowly beginning to embrace risk in contracts with hospitals. Will AdvaMed embrace the change, go along with it grudgingly or try to fight it? Nancy Crotti. The medical device industry is at the peak of 3-D printing hype--but there are also many applications of the technology already in use, according to a new report. Designed to monitor pulmonary artery pressure data to help treat patients with NYHA Class III heart failure, the technology posed unique product development challeng Meet Omar Ishrak, Medtech's Mr.
Designing Next-Generation Biomaterials A researcher at Penn State has helped develop promising citrate-based biomaterials. How Big Data Could Reach Its Medtech Potential Here are three things that need to be overcome when it comes to turning raw medical data into actionable information, courtesy of wireless technologies consultant and entrepreneur Upkar J.
How China's Black Monday Hit the Top 10 Medtech Firms A handful of medical device companies that do a large amount of business overseas were hit especially hard by Wall Street's worst day in four years. Design Reviews: When and How Many? When it comes to design reviews, the key is having a defensible, justifiable position that is well documented within your design and development process. Building a Strategic Patent Portfolio Here are time and money saving patent strategies for early-stage medtech companies.
How to Take 3-D Printing Beyond Prototyping Here are three important things that medical device makers should consider as they examine the pros and cons of 3-D printing, courtesy of Andreas Pfahnl of. WiTricity's wireless power technology has already sparked some interest in medtech circles.
Discover some of the next steps for. We took a look at where 15 prominent Republicans running for president stand on issues like Obamacare and the medical device tax. Which one will get your vote in the primary? Ben Carson. Bobby Jindal. Carly Fiorina. Donald Trump. John Kasich. Lindsey Graham. Mike Huckabee Mike Huckabee. Rand Paul. Rick Perry. Rick Santorum. Scott Walker. Ted Cruz. Marco Rubio. According to the report, the glo The company's story shows it is possible to make money while conducting market research. Devices in such recalls could potentially severely injure or kill patients.
A Device to Tackle Football's Concussion Problem The thing with football, it just takes one hit for athletes to face a severe head and neck injury that could threaten their career and possibly life. A company has a device that it hopes can help athletes of nearly all ages, and possibly even help Innovating Against Superbug Infections Identifying opportunities for device innovation to reduce and prevent healthcare-associated infections. Move Over Graphene, Meet the Next Wonder Material Black phosphorus, rather than graphene, could be the first material to herald a new era of nanoelectronic devices.
Here are a few things you won't want to miss at the show. Overall, employment at the largest medtech companies has increased, but some companies are cutting workforce through divestment, such as Alere. Which other companies reduced headcout in ? Smedley was sentenced to three years in prison for conspiring to introduce and deliver into interstate commerce an adulter Here are three things to get you started, courtesy of GE Healthcare's product security engineering director. Progress is being made when it comes to moving away from guinea pigs and rabbits, and developing lab-based tests acceptable to FDA.
Service vs. Maria Shepherd. Here are 10 medical device-related crimes that landed perpetrators in jail. Surviving is a coin toss, and others may want to devour your brains. If you've had interactions with FDA, we want to hear how you'd grade the regulator. The Importance of Intellectual Property in the Device Lifecycle Intellectual property considerations need to be made at every stage of a medical device product lifecycyle to ensure strong protection and increases chances of commercial success.
Yet some U. Device Interoperability Is A Key Missing Link in Home-Based Care New models of care delivery are being tested for a population that is rapidly aging, but for healthcare data to flow seamlessly, interoperability is a must. The Ins and Outs of Laser Process Validation Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is cruc A new Yale University-led study finds few studies three to five years after FDA approval of risky medical devices. Brian Buntz. Medtronic sits at the top of the medtech mountain in terms of employment, market cap and sales.
But how have employment levels of other top companies changed since ? Infographic: Top Tech Advances of In June, we asked our audience to pick the most promising technological breakthroughs of the first half of the year. Contenders included injectable brain electronics and Terminator 2-inspired 3-D printing. The four technologies featured here won out i New research from Harvard Business School finds first mover devices have a regulatory disadvantage at FDA, making it particularly hard for small firms to be first to market.
The reasons for delay may surprise you. Government Accountability Office to scrutinize. Here's the Skinny on Dexcom's Partnership with Google Dexcom is partnering with Google's life sciences team to develop and commercialize next-gen continuous glucose monitoring products that are smaller, cheaper, lighter and disposable. It All Comes Down to the Tubing A new ebook sponsored by Optinova covers the basics of tubing and extrusion in medical manufacturing.
Which regions are leading this innovation? What Google's Restructuring Could Mean for Medtech What used to be Google may be already acting more nimble in the medical devices space, now that some life sciences business have been separated out from Google under a new umbrella company called Alphabet. Here are the basics to get you started in the world of laser wire stripping for medtech. Adapting to the Evolving Healthcare Delivery Marketplace Medical device makers need to rethink their sales approaches and consider risk-based agreements if they want to compete in the new healthcare landscape.
The new brand While it would be logical to assume that the megamergers that medtech witnessed last year would result in significant layoffs, the biggest job cuts of were seen in the diagnostic device sector. Last month, senators proposed a bill to reform FDA's combination product regulations, but experts don't agree on the details of the legislation.
Outsourcing Medical Product Development the Right Way Farm Design has advice on how to get the most out of outsourcing medtech development. But believe it or not, coming up with your idea is the easy part. The Regulatory Challenges of Obtaining k Clearance for Devices with Antibiotics Numerous hurdles face those attempting to bring medical devices containing antibiotics to market.
He also cofounded the company that is attempting to overhaul how consumers access retail healthcare. Ginni Rometty. Smaller, Smarter Medical Sensors Will Transform Healthcare Advances in sensor technology and data analytics are coming together to put unprecedented power and insight into the hands of patients and healthcare providers.
Unleashing the Potential of Conductive Polymers Conjugated polymers could potentially be used in an array of electronics applications, but, to date, scientists have puzzled over how the materials can conduct electricity. That may have just changed. Duodenoscope Still Dirty? FDA Has No Perfect Answer in Duodenoscope Scare The agency is now informing health providers of options to prevent the scopes from causing superbug outbreaks, but none of them are optimal.