Month: June 2021

Chipotle, E. coli, and more: The surprising truths about food-borne illnesses

first_img Related: By Sheila Kaplan Jan. 15, 2016 Reprints A Chipotle restaurant worker fills an order. An outbreak of E. coli at the chain has now spread to nine states and sickened 52 people since October. Joe Raedle/Getty Images The Centers for Disease Control and Prevention, which tracks both outbreaks like those at Chipotle and isolated occurrences, estimates that 48 million people contract food-borne diseases each year. Only a small number of those cases are considered actual outbreaks — defined as two or more people getting sick from the same source.Will investigators be able to determine what caused the Chipotle outbreak? Hard to say. The Center for Science in the Public Interest, a Washington public health group that analyzed the CDC records, released a report in November that found only 40 percent of such cases are ever solved.advertisement Who will manage outbreaks? A crisis looms for infectious disease specialists Here are some other surprising facts about food-borne disease outbreaks:You are safer in a fast-food restaurant than at a swanky restaurantCDC statistics show that from 1998 to 2014, there were 1,969 outbreaks in “sit-down” restaurants, causing 26,350 illnesses, 1,206 hospitalizations, and eight deaths. By comparison, fast-food restaurants were the source of only 365 outbreaks, 5,624 illnesses, 533 hospitalizations, and three deaths.David Plunkett, a senior food safety attorney with CSPI and co-author of the report released last week, said standardization at fast-food restaurants helps make them safer. “You can’t walk into a McDonald’s and say, ‘I’d like my hamburger rare,’” Plunkett explained. “’You should be less suspicious of the meat and more suspicious of the things that are going to be on the food raw, such as lettuce or a salad-type option.”The herd in your hamburgerThere can be as many as 100 or more beef cattle parts combined into one hamburger and parts from dozens of chickens in one patty. The odds of one of them being contaminated increase with the numbers. And it only takes one to cause an illness. This doesn’t affect the risk of diseases like salmonella and campylobacter, more often associated with raw or undercooked food.Fresh doesn’t mean healthyAccording to CSPI’s report, which analyzed CDC data from 2004 to 2013, cilantro, cucumbers, cantaloupes, and peppers, often eaten raw, resulted in 629 outbreaks and almost 20,000 illnesses. On a pound-for-pound basis, however, fresh produce is safer than many other foods, the report noted.“You are twice as likely to get sick from eating a serving of chicken as from eating a serving of vegetables,” Plunkett said. The group also criticized the current food safety surveillance system, which is improving, but slowly. CSPI and other health groups have called for more funding of food safety surveillance activities across several federal agencies.You are likely to have already had food poisoningMost cases never get reported. That “stomach bug” you thought you had was likely the result of a food-borne pathogen. There are more than 250 pathogens capable of making you sick.Nursing home residents are vulnerableAccording to the CDC, there were 192 outbreaks in nursing homes and long-term care facilities from 1998 to 2014. Taken together, they caused 49 deaths — a higher ratio than outbreaks tied to grocery stores or restaurants.Cheese has cloutThe Food and Drug Administration recently adopted a stricter standard for raw milk cheese, basically lowering the amount of non-toxigenic E. coli that is permitted.Last week, Senators Patrick Leahy and Bernie Sanders and about 20 other lawmakers wrote the FDA to express their concern about the economic impact on their states’ raw milk cheese industry. “Such a drastic step,” they said, “would only be justified were these cheeses presenting a demonstrable public health risk, which, to date, we have not seen evidence of.”This story was updated to reflect the news that Chipotle was closing briefly on Feb. 8, 2016.  Chipotle will close all of its locations for a few hours on Feb. 8 for a company-wide meeting. On the agenda: food safety changes.The company has been plagued by a series of norovirus and E. coli outbreaks that sickened dozens and drove down sales. An investigation has not yet identified what specific food is linked to the illness.The outbreak garnered significant attention, in part because of the popularity of Chipotle, which has more than 1,500 locations worldwide. But the cases represent a drop in the bucket in the number of annual food-borne illnesses. In December, scores of students fell ill at a Chipotle restaurant in Boston after contracting what health officials described as norovirus.advertisement HealthChipotle, E. coli, and more: The surprising truths about food-borne illnesses Tags E. colifood poisoningfood-borne illnesslast_img read more

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Pharmalot, Pharmalittle: J&J layoffs, Brazil to help fund Zika vaccine development

first_imgPharmalotPharmalot, Pharmalittle: J&J layoffs, Brazil to help fund Zika vaccine development Ed Silverman About the Author Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Alex Hogan/STAT The Brazilian government plans to provide funding to a research center that will work on developing a vaccine against the Zika virus, the Associated Press reports. Brazil is currently experiencing the largest known outbreak of the virus, which has been linked to a recent surge in birth defects, including microcephaly. What is Zika virus?Volume 90%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/pharmalot/2016/01/19/johnson-johnson-layoffs-brazil-zika/?jwsource=clCopied EmbedCopiedLive00:0001:0801:08  Zika virus, which can be transmitted by mosquitos, has exploded onto the world stage in recent weeks. Alex Hogan/STAT In an unusual move, Sarepta Therapeutics filed yet another briefing document in advance of an FDA advisory panel meeting to be held on Friday to review its drug for Duchenne muscular dystrophy. Although the drug maker already submitted its briefing documents, the new nine-page filing was made after the FDA posted a negative review of the drug on the agency web site late last week.advertisement @Pharmalot center_img [email protected] The Indian government is considering a proposal to limit drug price margins to 35 percent, according to The Economic Times. The move is in response to claims that some wholesalers and retail pharmacies are charging excessive prices of as much as 3,000 percent, in some cases. India already caps the price of 680 drugs on its National List of Essential Medicines.Acorda Therapeutics agreed to pay $363 million to buy Biotie Therapies and gain access to a Parkinson’s drug, The Street reports.The Harvoni hepatitis C drug made by Gilead Sciences is about to become available in Egypt at a discounted rate, according to The Egypt Independent.New research from Johns Hopkins University found a compound that could treat symptoms of depression within hours, part of a wave of research into fast-acting antidepressants, STAT writes.Biogen and Samsung Group won European Commission approval for their biosimilar version of the Enbrel rheumatoid arthritis treatment sold by Amgen, The Boston Globe reports.The number of prescriptions dispensed in England for medications that are used to treat Alzheimer’s disease has jumped sixfold from a decade ago, Pharma Times writes.A Philadelphia judge added nearly $800,000 to a $12.5 million verdict that was awarded in a case last month in which Johnson & Johnson failed to properly warn about the risks of its pelvic mesh, The Legal Intelligencer says. By Ed Silverman Jan. 19, 2016 Reprints Good morning, everyone, and welcome to another working week. However, this is already an abbreviated session on this side of the pond, thanks to a federal holiday. We hope the respite was rewarding, because this means there is twice as much to do today, thanks to an accelerated schedule of meetings, phone calls, and the like. So the time has come to get cracking. As always, here are some tidbits to get you started. Have a smashing day and do stay in touch …Johnson & Johnson plans to cut about 3,000 jobs, or 4 percent to 6 percent of the positions in its medical devices unit, over the next two years. The move, which is designed to save between $800 million and $1 billion, would affect the orthopedics, surgery, and cardiovascular businesses, according to a statement. The health care giant employs about 127,000 people, including roughly 60,000 in the devices unit, which generated $27.5 billion in sales last year.Wockhardt says that problems at a plant that were noted in an FDA report are not “critical” and should be resolved over the next two months, The Economic Times reports. The generic drug maker says none of the issues at the Shendra facility, which produces various capsules and tablets for the United Kingdom and Ireland, were related to data integrity. Two other plants are banned from shipping products to the US market.advertisement Tags Johnson & JohnsonZika Viruslast_img read more

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How a molecular tweak could help fight killer C. diff infections

first_img Hospitals and nursing homes have long battled the bacterium Clostridium difficile, which can dangerously inflame the colon and cause diarrhea. In 2011 alone, nearly half a million Americans suffered from a C. diff infection, and about 15,000 people died as a direct result.A natural compound called InsP6 is recognized to have promise in neutralizing the toxins produced by C. diff, but progress in refining it has lagged. Now, new research in mice shows that swapping out a single atom in InsP6 makes it significantly more effective. Here’s what the study’s senior author, Dr. Tor Savidge of Baylor College of Medicine, said about his team’s findings, published in Science Advances.What’s wrong with the way InsP6 works right now?It doesn’t work efficiently enough when delivered as an oral therapy. One reason is it’s not potent enough. Although it may cleave some toxin, it doesn’t neutralize enough toxin to make it effective as a drug.advertisement Privacy Policy Leave this field empty if you’re human: Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. How does your research overcome that problem?These toxins have evolved to activate when they enter the cell of the host. So our strategy here has been to try to head fake these toxins to think they’re actually inside the cell. So we flush the extracellular system with a redesigned compound so the toxin thinks it’s inside the cell. It then cleaves, rendering in effect the toxin inactive in terms of its ability to cause disease.What do you still need to find out?We need to test it in other preclinical models. We need to demonstrate using a number of different C. diff strains — each strain has a variation of the toxin — to show that it’s working.advertisement CDCcenter_img Please enter a valid email address. By Rebecca Robbins March 28, 2016 Reprints Lab ChatHow a molecular tweak could help fight killer C. diff infections Tags bacteriadrug developmentinfectionlast_img read more

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This medical center looks and feels like an Apple Store

first_img “It can’t hurt to have a nice facility, but there are some people who can’t afford to get in the door.” Johnson said the design might improve patients’ outcomes as well, since they may bring a more positive attitude to their chemo treatments.Some design experts aren’t so sure.George J. Mann, a Texas A&M University architecture professor specializing in health care design, said he is skeptical of the trend toward expensive, amenity-filled hospitals, and theories about how design can promote healing.For 25 years, health care companies have tried to compete in multi-hospital markets by building more facilities with private rooms, open corridors, fancy lobby furniture, and enormous atriums that cost a lot to heat and cool, Mann said. Those costs are passed down to patients.“Sometimes it’s implied that the amenities will help them get better, but I don’t think so,” said Mann, who has not yet studied the Minnesota facility. “It can’t hurt to have a nice facility, but there are some people who can’t afford to get in the door.”Johnson said she is confident that this particular design won’t suffer the same flaws. The university, she said, will analyze metrics from patient and staff badges and satisfaction surveys, and will publish results in academic journals.“We really feel like this will lower the cost of health care,” she said, by increasing efficiency and patient satisfaction, and diminishing the need to return to the center for care. “The data will be really important.” The University of Minnesota Health Clinics and Surgery Center in Minneapolis was inspired by the Apple Store. Craig Dugan for CannonDesign Privacy Policy Please enter a valid email address. Related: Leave this field empty if you’re human: HealthThis medical center looks and feels like an Apple Store Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day.center_img It’s a $165 million risk, to be precise. But the bet is that the approach will increase patient satisfaction and staff efficiency, all with a design footprint that’s smaller than other academic medical centers with similar patient loads and staffing levels.The smaller footprint has allowed the university to save $25 million in construction costs, Johnson said, with more savings in lease payments and maintenance.The facility isn’t tiny, though. The five-story, 342,000-square-foot building houses an inpatient surgical center and several adult clinics, and can serve more than 2,000 patients per day.Unlike at other academic medical institutions, nobody at the center gets an office. The center’s design firm, Boston-based architectural firm CannonDesign, said that research shows private doctors’ offices are literally a waste of space, sitting empty 90 percent of the time.Instead, staff members are given desks along broad banks of windows upstairs, conference rooms, and a three-story open-air staff lounge space. (Patient-care rooms are clustered at the building’s center.) Office materials are designed to deaden sound, and the HVAC system infuses the area with white noise for privacy.“We’re asking staff to make quite a huge culture shift,” Johnson said.David J. Allison, the director of Clemson University’s Graduate Studies in Architecture and Health program, said the decision to forgo dedicated office space is in keeping with trends seen in commercial buildings, where the notion of “hoteling” means that no one has permanent working spaces.The approach can work especially well in a health care environment, he said, given that it compels medical team members to interact more frequently and directly.“More and more care is being delivered by collaborative teams that need to work in concert,” he said. “That’s going to be the future.”Patients have had to reorient themselves, too, including in ways that might test their comfort levels.When they arrive at the clinic, they are given badges embedded with wireless technology that tracks the their movements through the facility, as well as how long they’ve been waiting in any given room. If the system detects that a patient has been alone in a room for 10 minutes, staff members receive an automated alert, directing them to check in.Staff members will also get the badges, so they can find each other more quickly.Other patient-centric design touches include chemotherapy stations. Whereas some chemo rooms are open-air expanses filled with recliners, the chemotherapy clinic at the new facility includes a handful of infusion bays with wall panels that can slide closed for privacy or open for socializing. Steve Jobs may have changed technology forever but, with the design of his iconic Apple Stores, he also left his mark on the design of physical spaces.Now his legacy is being felt in an unlikely place: a hospital.The University of Minnesota Health Clinics and Surgery Center in Minneapolis, which opened earlier this year, was inspired by the Apple Store, designed to be more experience than ambulatory site.advertisement The similarities are obvious: No lines. No intake desks with authority figures. Instead, visitors find concierges at the door and a wide-open floor plan with walls of glass. Patients can find appointment information online, in advance, to save time and hassle, as they would before checking in at an airport.“We took a really big risk here,” Mary Johnson, the organization’s chief operating officer, told STAT.advertisement By Bob Tedeschi April 27, 2016 Reprints In Kendall Square, architects compete to redefine the laboratory George J. Mann, Texas A&M University Tags hospitalstechnologylast_img read more

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FDA’s drug approval process should be based on science, not public opinion

first_img An FDA advisory committee meets in Silver Spring, Md. Chip Somodevilla/Getty Images About the Author Reprints First OpinionFDA’s drug approval process should be based on science, not public opinion David Gortler Related: Newsletters Sign up for Pharmalot Your daily update on the drug industry. FDA delays decision on whether to approve Sarepta drug for Duchenne Marco Rubio to FDA: Don’t yank hope from dying children “Right-to-try” legislation makes sense for people who don’t understand the complexities of the drug development process. As a rare Republican working at the FDA and a generally politically conservative person, I am all for more freedom and less government intervention — but not when it comes to drug approval. The truth is, I am not quite ready to entrust the general public (or, for that matter, a senator with no scientific or clinical background) to circumvent the FDA through “right-to-try” and to make independent recommendations regarding clinical pharmacology, pharmacogenomics, biomarkers, and long-term drug safety.I understand Senator Rubio’s desire to advocate for drugs for rare diseases. But he ought to leave the complexities of drug evaluation and review to experienced FDA scientists. By David Gortler June 2, 2016 Reprints Please enter a valid email address. I can tell STAT readers a secret about the “public speaking” portion of FDA advisory committee meetings: It is all for show. I can recall my FDA supervisors and colleagues checking their emails, doodling, texting, and the like to avoid listening to individuals who would often travel great distances to pour out their hearts to the advisory committee and FDA reviewers, literally begging them to approve a new drug.The clinical and regulatory review process is extremely complicated and is — or should be — 100 percent based on the safety and efficacy outcomes that emerged from the clinical trial. Even experienced pharmacologists and physicians need years of experience to fully appreciate the complexity of the process. That’s why drug-approval decisions are best left to the experts.advertisement Senator Marco Rubio’s essay criticizing the FDA for failing to approve eteplirsen, an investigational drug for Duchenne muscular dystrophy made by Sarepta Therapeutics, highlights a glaring misunderstanding of the drug approval process. Public appeals like Rubio’s and those made by Duchenne families are perfectly appropriate and make for interesting public theater. But they have essentially zero effect on the FDA’s decision-making cascade.As a former FDA medical officer and senior medical analyst, as well as a former investigational medicine research scientist at Pfizer, I don’t always agree with the regulatory decisions the FDA makes. However, I do support the time-tested process for approving new drugs. It’s easy to see why the public, and even politicians like Senator Rubio, are confused by the FDA’s seemingly likely decision to reject eteplirsen in light of several other highly controversial FDA approvals.For example, last year the FDA gave the green light to flibanserin (Addyi), a drug to treat low sexual desire in women. Although this is a problem for some women, it does not represent a big public health issue, is not debilitating or fatal, and has significant safety issues. What’s more, flibanserin doesn’t work for the vast majority of women, positively affecting only between 8 and 13 percent of those who take it. In addition, flibanserin has potentially fatal drug-drug interactions with alcohol and the most commonly prescribed antibiotics and antifungals currently on the market. Some prominent national health women’s groups have voiced their opposition to its approval.In contrast, Duchenne muscular dystrophy affects children and young people, robs them of an active life, and is always fatal. Even if eteplirsen, the new drug for Duchenne, has both safety and efficacy issues, the decision not to approve it, in light of the decision to approve flibanserin, has left many people, including most clinical scientists, scratching their heads in confusion.The FDA’s impending decision isn’t necessarily a death sentence for eteplirsen or for a similar Duchenne drug made by PTC Therapeutics, which was also rejected. A third competitor, BioMarin Pharmaceutical, has just abandoned all of its most advanced Duchenne projects. Many drugs currently on the market required multiple FDA advisory committee meetings, or weren’t approved on the first or even the second review. In fact, flibanserin was one of those — it took three separate submissions to finally gain FDA approval. Privacy Policy Leave this field empty if you’re human: If these companies truly believe that their investigational drugs for Duchenne hold clinical promise, they should stick by their compounds and do whatever FDA-required clinical testing is needed to fully comply with the FDA’s requirements for approval. That’s what the makers of flibanserin did, and they were eventually able to convince advisory committees and the FDA, in spite of what can only be described as very poor efficacy and safety profiles.My advice to these companies: Stop the public relations campaigns, which do nothing to sway the FDA’s decision making process. My advice to my fellow Republican, Senator Marco Rubio: If you are upset with the way the FDA does business, create new legislation to change how it works. Or maintain the status quo and leave the new drug reviews and approvals to FDA scientists, like the ones who approved flibanserin.David Gortler, PharmD, has two decades of drug development experience. He has been an investigational medicine research scientist at Pfizer, a medical officer/senior medical analyst with the FDA, and a professor of pharmacology at Yale University School of Medicine and Georgetown University School of Medicine. He is now a drug safety expert and FDA policy expert with the consulting group FormerFDA.com. Related: The FDA’s mission requires that it be sure that the drugs it approves are safe and effective. To do this it needs concrete data from controlled clinical data that prove the drug works better than (or, in some cases, at least as well as) an existing therapy. Emotional appeals from the public or from politicians do nothing to establish the parameters of safety or efficacy.advertisement Tags clinical trialsduchenne muscular dystrophyFDAlast_img read more

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European Union moves toward a formal policy for reviewing new medicines

first_img [email protected] About the Author Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED APStock In a move that elicited rare agreement among groups representing consumers and the pharmaceutical industry, the European Commission proposed various steps to accelerate the approval of drugs and devices by European Union member states.Although the proposal follows more than 20 years of voluntary cooperation, the commission is hoping to memorialize the effort in order to streamline procedures that so medical products can reach patients faster and companies can more easily seek regulatory approvals. Ed Silverman Tags pharmaceuticalspolicySTAT+ What is it? Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. European Union moves toward a formal policy for reviewing new medicines center_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What’s included? GET STARTED Log In | Learn More Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. By Ed Silverman Jan. 31, 2018 Reprints Pharmalot @Pharmalot last_img read more

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Panel recommends FDA approval of epilepsy drug derived from marijuana

first_img Some patients in the trials experienced sleepiness or gastrointestinal issues, and the medication did not work for all patients. There is also some concern about the effect of the drug on the liver. In the briefing documents, the FDA officials wrote that the “risk of liver injury has the potential to be serious,” but that it could be addressed by tracking liver function during treatment.Panelists said they were swayed by robust efficacy data from three clinical trials and that clinicians could easily handle any worries about side effects.“The safety concerns could be managed with labeling and monitoring,” said Jane Acri, a panel member who works in medication development at the National Institute on Drug Abuse.In sometimes emotional testimony, the parents of children with the conditions urged the panel and FDA to get the drug to the market. They described how they have to watch their children constantly, and the horror of their children’s seizures, which can be so violent they break bones. They explained the developmental setbacks their children faced and the problems with other medications and therapies they had tried.“She couldn’t go outside, she couldn’t do anything that other kids do,” said Stephen Carlin, who showed videos of his daughter, Zora, who has Dravet syndrome, having seizures. Please enter a valid email address. In a first, scientists show a marijuana component reduces seizures for some with epilepsy [email protected] An expert panel on Thursday unanimously recommended that the Food and Drug Administration approve a new medicine for two rare and devastating forms of epilepsy, paving the way for the authorization of what would be the country’s first medication made from marijuana.The 13-0 vote from the FDA advisory committee is not binding, and the agency is expected to announce its decision by the end of June. But in documents this week, FDA officials wrote they supported the approval of the drug, Epidiolex, after concluding that it cut the number of seizures in patients in clinical trials.“This is clearly a breakthrough drug for an awful disease,” said Dr. John Mendelson, a panel member and senior research scientist at Friends Research Institute.advertisement General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. Andrew Joseph Privacy Policy Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Epidiolex, which is given as an oral solution, consists of cannabidiol, or CBD, a component of cannabis that does not make people high. Its manufacturer, GW Pharmaceuticals, is seeking its approval to treat Lennox-Gastaut and Dravet syndromes, two conditions that typically emerge in the first few years of life. Patients suffer from severe seizures, and an estimated 20 percent of patients die by the time they are 20 years old.In trials, patients taking Epidiolex saw their monthly seizures reduced by about 40 percent.advertisement Leave this field empty if you’re human: But after receiving Epidiolex, “her seizures went from 40 to 50 a day to only a few or none per week,” said Carlin, whose travel was paid for by GW.Some families have moved to states where marijuana is legal either recreationally or medically to obtain CBD oil for their children’s epilepsy, and some states have changed their laws to make CBD oil available. But experts have said that having an approved and regulated medication available in a standard dose is important because self-treating can expose patients to irregular doses, substandard supplies, or the risk of side effects without medical oversight.Evelyn Nussenbaum, the mother of a child with epilepsy, told the panel that she had tried to buy CBD from retailers, but that when she had it tested, she found out that many of them had lower concentrations of CBD than on the label, and some had none at all.The Drug Enforcement Administration continues to classify marijuana as a Schedule I drug, meaning it has no proven medical value and a high risk of abuse. If Epidiolex is approved, the DEA will then have to reschedule cannabidiol — given that FDA approval demonstrates a medical value — but can leave cannabis overall at Schedule 1.The FDA has previously approved synthetic medications — including Marinol and Cesamet — that resemble or are identical to THC, the component of marijuana that makes people high. The drugs, which are approved to treat nausea from chemotherapy and other conditions, are listed at Schedule III and Schedule II, respectively. HealthPanel recommends FDA approval of epilepsy drug derived from marijuana An expert panel on Thursday unanimously recommended that the FDA approve Epidiolex for two rare and devastating forms of epilepsy. Kathy Young/AP Epidiolex comes from a proprietary strain of cannabis grown by GW that has been bred to have high levels of CBD and low levels of THC.Analysts had expected a positive advisory committee recommendation, and they also expect the drug to be prescribed off-label for other types of epilepsy if it is approved. Ahead of Thursday’s advisory committee review, shares of GW Pharma were up about 7 percent this week.There are six other drugs approved to treat seizures associated with Lennox-Gastaut, but none approved for Dravet. Trending Now: Related: Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. @DrewQJoseph By Andrew Joseph April 19, 2018 Reprints About the Author Reprints Tags drug developmentneurologyresearchlast_img read more

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LISTEN: Twitter vitriol, biotech jargon, and the plight of the CEO

first_img Adam Feuerstein National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. Tags biotechnologypodcast What is it? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED @damiangarde Damian Garde Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. LISTEN: Twitter vitriol, biotech jargon, and the plight of the CEO The Readout LOUD GET STARTED What’s included? [email protected] Why is Twitter so mean to Axovant Sciences? Will sci-fi new medicines ever go mainstream? And what are oncologists even talking about?We discuss all that and more in the latest episode of “The Readout LOUD,” STAT’s biotech podcast. Tune in for a discussion of how biotech’s biggest recent blow-up hopes to turn things around, an explanation of biotech jargon that will unnerve actual statisticians, and an interview with Nina Kjellson, a VC at Canaan Partners, about the future of cell and gene therapy. Then comes a lightning round about the diverging fates of various CEOs. About the Authors Reprints Log In | Learn More @adamfeuerstein [email protected] By Damian Garde , Rebecca Robbins, and Adam Feuerstein June 7, 2018 Reprintslast_img read more

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Here’s the data behind the new Apple Watch EKG app

first_img About the Author Reprints By Kate Sheridan Sept. 13, 2018 Reprints When the new Apple Watch heart monitoring app can get a reading, it can accurately detect that a person has an irregular heart rhythm known as atrial fibrillation 99 percent of the time, according to a study of the new device that Apple submitted to the Food and Drug Administration.The agency shared with STAT a summary of the clinical data that Apple submitted as part of its clearance application.In one study, Apple tested the watch in more than 580 people, half of whom had atrial fibrillation. The app couldn’t read about 10 percent of the heart rhythm recordings in the study. When it looked at the rest, though, the app was very accurate: It caught more than 98 percent of people with atrial fibrillation, and correctly told people that they didn’t have the condition 99.6 percent of the time.advertisement Exclusive analysis of biopharma, health policy, and the life sciences. The second submitted data set was part of Stanford’s Apple Heart Study. For it, Apple examined 226 people that the app classified as having an irregular heart rhythm — but not necessarily atrial fibrillation. Those individuals wore both the Apple Watch and a traditional, wearable heart monitor and moved around normally for about a week.advertisement STAT+: @sheridan_kate HealthHere’s the data behind the new Apple Watch EKG app Atrial fibrillation is a condition associated with a higher risk of stroke and heart failure. It happens when the parts of the heart don’t beat together correctly. During the monitoring period, about 41 percent of people had an irregular heart rhythm or event that looked like atrial fibrillation show up on their traditional monitors. In about 79 percent of those cases, the app also picked something up.Going after atrial fibrillation first makes sense, said Dr. Sekar Kathiresan, a physician-scientist at Massachusetts General Hospital and the Broad Institute who studies the genetic risk factors for cardiovascular disease.“It’s an important disease. As far as heart rhythm disturbances go, it’s the most common,” he said “It’s a condition where, often, the first presentation is stroke. And it’s a condition that if you catch it early, there’s an effective treatment — blood thinners. In many ways, it’s kind of an ideal scenario for a screening test.”Kathiresan said the most important data point for consumers answers a simple question: if the app gives a problematic reading, how likely is it that the reading is correct?That figure is the app’s “positive predictive value,” and Kathiresan calculates that for people using Apple’s EKG app to look for atrial fibrillation, that number is about 45 percent. He based that calculation on the figures from the studies FDA shared.More than half the time the app flags a problem, then, the app will be wrong.“For even a very accurate test in a condition that is [uncommon], most of the tests that are going to come back will be false positives,” Kathiresan said.Doctors whose patient populations sport Apple Watches may need to brace themselves for an influx of patients who will want to see a specialist when they receive an irregular heart rhythm alert, Kathiresan said.Young people with disposable income — like many current Apple Watch users — are among the least likely to have atrial fibrillation, he added. For them, he said “it’s even more likely that a positive result will be a false positive.”Apple may be targeting older consumers with this new version of the watch, particularly since the watch will also come with fall detector that can alert emergency services if the wearer doesn’t move for a minute.Apple did not immediately respond to a request for comment. The new Apple Watch Justin Sullivan/Getty Images [email protected] Kate Sheridan General Assignment Reporter Kate covers biotech startups and the venture capital firms that back them. Tags government agenciesmedical devicespolicylast_img read more

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Amid a market slump, biotech makes room for unicorns

first_img Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED @damiangarde Amid a market slump, biotech makes room for unicorns National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. GET STARTED Damian Garde Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. What is it? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Tags biotechnologySTAT+center_img About the Author Reprints While biotech’s fortunes have soured on Wall Street this week, the sector’s biggest IPO of the year went off without a hitch Thursday, suggesting investors haven’t lost their appetite for high-risk, high-reward science.Allogene Therapeutics (ALLO), a company focused on cancer, raised more than $300 million in its market debut, securing a valuation of roughly $2.5 billion. And the company got a warm reception in early trading, rising more than 30 percent by mid-morning. APStock [email protected] What’s included? By Damian Garde Oct. 11, 2018 Reprints Log In | Learn More Biotech last_img read more

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