By Ed Silverman Dec. 8, 2015 Reprints PharmalotPharmalot, Pharmalittle: Valeant feels attacked, Alzheimer’s risk with prostate cancer drug Alex Hogan/STAT About the Author Reprints Ed Silverman Tags ADHDAlzheimer’sValeant Pharmaceuticals Rise and shine, everyone, another busy day is on the way. And we are no exception as we take our regular sojourn to the STAT offices far from the Pharmalot campus. This calls for a few cups of stimulation, which we will have to procure from sources other than our trusty coffee kettle. While we forage, you may enjoy some of items of interest we have assembled below. Hope you conquer the world today and, of course, keep us in mind when you hear something fascinating …Valeant Pharmaceuticals is trying to find a buyer for Paragon Vision Services, a contact lens manufacturing unit, amid scrutiny from the US Federal Trade Commission, Reuters reports. The FTC is looking at whether purchasing Paragon gave Valeant monopoly control over the market for rigid contact lenses. Valeant purchased Paragon last May and acquired Bausch & Lomb in 2013.Meanwhile, Valeant Pharmaceuticals is chafing from the withering attacks on its business practices over the past several weeks, according to The Wall Street Journal. “We are being attacked by everyone. We have few friends to defend ourselves,” Theo Melas-Kyriazi, a Valeant director since 2005, tells the paper.advertisement Men taking drugs to block testosterone to treat prostate cancer have nearly twice the risk of developing Alzheimer’s as men using other treatments, writes The Wall Street Journal. A study identified 16,888 patients with non-metastatic prostate cancer between 1994 and 2013. Nearly 2,400 were treated with anti-androgen drugs and had an 88 percent higher risk of an Alzheimer’s diagnosis than those who did not take the drugs.The FDA approved a chewable tablet containing extended-release methylphenidate, which is the key ingredient in Ritalin, for treating ADHD in children six years and older, MedPage Today informs us.advertisement @Pharmalot AstraZeneca plans to use a mobile app to gather information about side effects in three clinical trials studying a treatment for ovarian cancer, Medical Marketing & Media says.TherapeuticsMD stock jumped after the drug maker said a trial of a hormonal treatment to reduce vaginal pain during intercourse was successful, Bloomberg News writes.Drug makers asked the FDA to further explain the intended use of quality metrics data to be collected after the agency issued draft guidance this summer, Regulatory Focus reports.Roche signed a development deal that could be worth more than $500 million with SQZ Biotech, which developed a chip for helping the body’s immune system to fight disease, The Boston Business Journal tells us.Hetero became the first company in India to receive approval to market a generic version of Gilead Sciences’s Harvoni hepatitis C treatment under a non-exclusive licensing agreement, The Economic Times writes.A meta-analysis that compared the safety and efficacy of once-weekly GLP-1RAs treatments for type 2 diabetes failed to find a clear winner, MedPage Today says. [email protected] Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry.
Month: June 2021
Compounding involves making a personalized medicine for a patient. But in 2014, the benefits manager began blocking coverage for ingredients used to make ointments, creams, and powders that are found in topical treatments. The company said the average cost for each prescription jumped to $1,100 from $90, and maintained that less costly medicines are readily available.“We have no comment on the litigation, but we will vigorously defend ourselves,” an Express Scripts spokesman wrote us. “We also remain committed to help our clients save money by controlling compound spend and providing access to cost-effective alternatives.”The move to cut back on covered ingredients has riled compounding pharmacies, which have been under a microscope ever since a 2012 outbreak of fungal meningitis was traced to the New England Compounding Center. The episode led to 64 deaths around the country and was described by federal health officials as the worst public health crisis in the United States in decades.In response, the Food and Drug Administration has cracked down on compounding pharmacies by increasing the number of inspections, and, in rare cases, taking legal action to halt allegedly unsafe practices. The justifiable emphasis on safety has forced many compounding pharmacies to enhance operations, but the move by Express Scripts to limit coverage has further pressured their bottom lines.The compounding pharmacies are striking back. In November 2014, three others filed a lawsuit claiming Express Scripts illegally blocked legitimate prescriptions and unfairly forced patients to seek more expensive medicines or simply not seek treatment. The pharmacies maintained the benefits manager violated federal law because it lacks authority to essentially alter terms of health plans.In the latest lawsuit, the benefits manager is accused of increasing rejection rates for claims submitted for compounded medicines; sending “misleading” letters to patients to say the compounded medicines they were prescribed lacked FDA approval and were unsafe; instructing doctors not to write prescriptions for compounded medicines; and creating obstacles for compounding pharmacies to receive reimbursement, among other things.For the 12-month period beginning on Oct. 1, 2014, through Sept. 30, 2015, the economic impact of the moves made by Express Scripts and other pharmacy benefit managers exceeded $100 million, according to the lawsuit. And the compounding pharmacies allege that about half of that is attributed to the actions taken by Express Scripts.The plaintiffs are seeking an injunction against Express Scripts and damages to be determined. Related: “It’s really a threat to compound pharmacy existence as a whole,” Steven Bloch, an attorney for the compounding pharmacies, told us. The lawsuit estimates that the pharmacies lost tens of millions of dollars in business.As a pharmacy benefits manager, Express Scripts negotiates contracts for prescription drug coverage on behalf of corporations, government agencies, and unions, among others. In this role, the company helps determine pricing and access through formularies, which are lists of preferred medicines.advertisement Compounding pharmacies are suing Express Scripts for antitrust and trying to force them out of business. Jeff Roberson/AP Express Scripts has taken “a series of unreasonable restrictions and rules that would make it impossible for [the compounding pharmacies] to fill prescriptions” for patients “and obtain reimbursements that would cover their costs,” according to the lawsuit, which was filed in federal court in St. Louis. The company and the other benefits managers “employed tactics designed to ensure that the compounding pharmacy industry … cannot survive.”advertisement FDA sues to stop a wayward drug compounder By Ed Silverman Jan. 20, 2016 Reprints For the second time since Express Scripts began blocking coverage of hundreds of ingredients used to make compounded medicines, several compounding pharmacies have filed a lawsuit accusing the pharmacy benefits manager of using illegal tactics.In the latest instance, a half-dozen compounding pharmacies have charged Express Scripts with violating antitrust laws and is attempting to force them out of business. And they allege that other pharmacy benefits managers are conspiring to do the same thing, although none are named as defendants. PharmalotExpress Scripts sued by compounding pharmacies for alleged antitrust practices [email protected] Ed Silverman Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. @Pharmalot About the Author Reprints Tags Express Scriptslawsuits
Nymphs questing through the forest. The phrase conjures up images of a scene from “Game of Thrones.” But encountering a real nymph on its quest offers a potentially harmful brush with climate change.Immature deer ticks are called questing nymphs. They now inhabit a wide swath of North American forests, but they didn’t always. During early summer, their quest is for blood. The season now starts earlier and lasts longer than it did in the past, which is good for the ticks. But it’s bad for humans, because these ticks carry the bacteria, viruses, and parasites that cause Lyme disease, anaplasmosis, deer tick encephalitis, and babesiosis.I have collected thousands of nymphs as part of my dissertation research on the invasion of Lyme disease across North America. I’ve witnessed along the way that where these ticks thrive has been heavily influenced by humans.advertisement Tags climate changeenvironmental healthLyme disease By Katharine Walter July 1, 2016 Reprints A deer tick resting on a blade of grass. CDC Deer tick invasionEncounters with ticks didn’t always cast a dark shadow over North American summers. Cases of Lyme disease first appeared in 1976 in the woodsy suburb of Lyme, Connecticut. At that time, deer ticks were found only in a hotbed encircling Long Island Sound, along with a small area in Wisconsin.Since the 1970s, deer ticks have rapidly extended their reach north, west, and south. The most recent map shows that deer ticks now roam throughout the eastern coastal states, from Maine to Florida, and across the Midwest. They are now established in 45 percent of US counties. That means the deer tick has more than doubled its reach in the 20 years since the previous map was published.advertisement The spread of Lyme disease has closely followed the spread of the forest nymphs. Lyme disease is now the most common disease transmitted by a vector — a mosquito, tick, or other bug — in United States. More than 30,000 cases are reported each year, and the Centers for Disease Control and Prevention estimates that 10 times as many Americans develop the disease.Regions where ticks that carry Lyme are established (red) or reported (blue). Alex Hogan/STATIn part, ticks are following the spread of one of their favorite sources of blood: deer. As deer populations exploded over the last sixty years, thanks to strict hunting laws and the largely predator-free and deer-friendly landscapes in New England and the Midwest, deer ticks followed. However, the steady crawl of ticks north into Canada can’t be explained by deer alone.Ticks spend the majority of their lives on the forest floor. They are vulnerable to changing local climates and death by freezing, drowning, or desiccation. Warmer winters and longer summers let more ticks survive and thrive further north each year. Warmer temperatures quicken the tick life cycle, too. Tick eggs hatch sooner and ticks spend more time questing for blood, and so are increasingly likely to feast on a human and pass on a disease-causing pathogen. Because more ticks survive and mature more quickly, diseases can be transmitted faster.Species that thrive under climate changeThe barriers we have created — the heated, cooled, and (somewhat) bug-free spaces we inhabit — give us an artificial sense of immunity to the disturbances shaking our fragile ecosystems. Nymphs don’t respect the barriers of urbanization and wealth that protect many Americans from vector-borne diseases. Window screens, socks, and our skin don’t stop the invasion of nymphs, reminding us of our vulnerability to ecological changes brought about by climate change, habitat fragmentation, and deforestation.As we worry about the ability of some species to run from climate change and escape extinction, ticks, mosquitoes, kissing bugs, and the parasites they carry may thrive under climate change. Where will these crawling and flying disease carriers move? And who will be at risk for what were once called tropical diseases? First OpinionClimate change is speeding the spread of Lyme disease [email protected] Related: About the Author Reprints The consequences of climate change will vary dramatically across the globe and are difficult to predict. The yellow fever mosquito (which also carries dengue, Zika, and chikungunya viruses), for instance, is predicted to spread rapidly in some areas, including eastern North America and large parts of southeast Asia, and become less common in others areas, like much of Australia.A changing climate will affect mosquito-borne diseases in subtler ways, too. In a warmer climate, the dengue virus matures more quickly (up to a certain temperature). That means an infected mosquito can more swiftly spread the virus.The consequences of climate change will be felt most profoundly by people living in or near areas where diseases carried by mosquitoes and other vectors are already common, and where poverty makes it difficult to stamp out these diseases.A forest nymph brushing against a hiker doesn’t begin to drink blood immediately. She crawls across the skin, searching for a comfortable dinner spot. She grips her prey with spindly legs and uses knife-like mouthparts to slice into human skin. She secretes cement around the wound, binding herself to her host, and then begins to imbibe. Once attached, this offspring of a changing climate can’t be simply brushed off.Katharine Walter is a graduate student in the Department of Epidemiology of Microbial Diseases at Yale University. Katharine Walter Persistent Lyme disease symptoms aren’t helped by long-term antibiotics
Lev Facher GET STARTED @levfacher Tags addictionDonald Trumpopioidspolicy WASHINGTON — President Trump’s commission on combating the opioid epidemic plans to encourage the federal government to establish drug courts in every federal judicial district, adjust reimbursement rates for addiction treatment, and streamline federal funding used by state and local governments to implement drug treatment and prevention programs, according to a draft of the panel’s final report.Those steps are among the 53 recommendations laid out in the draft, a copy of which was obtained by STAT. The final report is set to be released on Wednesday. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More What’s included? By Lev Facher Oct. 30, 2017 Reprints 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. [email protected] About the Author Reprints Trump opioid panel will recommend nationwide drug courts, tightened requirements for prescribers Washington Correspondent Lev Facher covers the politics of health and life sciences. President Trump with New Jersey Gov. Chris Christie, the chairman of the president’s commission on combatting the opioid crisis. Pablo Martinez Monsivais/AP Exclusive 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.
GET STARTED 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? Kate Sheridan Biotech Apstock About the Author Reprints General Assignment Reporter Kate covers biotech startups and the venture capital firms that back them. [email protected] There’s a massive new data set that aims to help artificial intelligence work better for biotech — and it’s free Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED By Kate Sheridan May 6, 2019 Reprints Artificial intelligence is the hot new thing in drug discovery and development. AstraZeneca, Pfizer, and Merck have all relied on machine learning to advance their research. Bristol-Myers Squibb and Boston-based Concerto HealthAI established a new partnership in March. And Relay Therapeutics raised an astonishing $400 million series C round to support its efforts to use AI techniques to understand the way proteins bend and twist and create new drugs.But if artificial intelligence programs are actually going to make an impact, they’re going to need a lot of data — and high quality data is hard to come by. Currently available data sets aren’t ideal for machine learning, and relying on that data might even set certain algorithms down the wrong path. Log In | Learn More 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. @sheridan_kate What is it? Tags biotechnologydrug developmentmedical technologyresearch
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. National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. @damiangarde Tags biotechnologyBostonSTAT+ The latest failure in Alzheimer’s casts doubt on Biogen’s ostensible success The prevailing theory of how to treat Alzheimer’s disease endured its 1,001st cut on Thursday, as results from a lengthy clinical trial showed that reducing toxic plaques in the brain had no effect on slowing cognitive decline.While the disappointing result is only the latest in a metronomic series of failures, it could have implications for the drug industry’s only ostensible success: a plaque-targeting treatment from Biogen soon to undergo Food and Drug Administration review. Damian Garde Log In | Learn More GET STARTED What’s included? About the Author Reprints What is it? Biotech [email protected] By Damian Garde April 2, 2020 Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED 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. In the Alzheimer’s affected brain, abnormal levels of the beta-amyloid protein clump together to form plaques (seen in brown) that collect between neurons and disrupt cell function. National Institute on Aging, NIH
Ed Silverman [email protected] Pharma is only ‘inching forward’ in boosting access to medicines in low-income countries Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Adobe Tags drug pricingglobal healthSTAT+ By Ed Silverman Jan. 27, 2021 Reprints About the Author Reprints 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’s included? 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. Like the proverbial tortoise, a new analysis finds that while the pharmaceutical industry is taking steps to provide access to its medicines, it is doing so at a slower pace than is needed for lower-income countries.The most notable sign of progress is in the R&D planning stages, as more drug makers are thinking ahead about access issues. Specifically, eight companies are developing approaches for systematically ensuring all of their R&D projects are positioned to increase access in low-income countries after product launches. Log In | Learn More Pharmalot @Pharmalot GET STARTED