PharmalotPharmalot, Pharmalittle: AstraZeneca suffers setback with its blood thinner [email protected] Vertex Pharmaceuticals suffered a setback as the UK’s National Institute for Health and Care Excellence issued draft guidelines rejecting the use of its Orkambi cystic fibrosis treatment, Pharma Times reports. The cost watchdog determined the cost was “considerably higher” than the current standard of care, and so the treatment would not be an effective use of resources, despite an ability to reduce hospitalizations.The US Food and Drug Administration plans to add black box warnings — the most serious type — to all immediate-release opioid painkillers, STAT tells us. These include combination pills containing oxycodone and non-prescription drug ingredients. The move comes three years after the FDA added stronger warnings to long-acting opioid drugs like OxyContin, which slowly release their doses.advertisement Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Top of the morning to you. And a fine one it is. The challenging mid-week slog may have arrived, but we are feeling optimistic thanks to a warm and shiny sun that is enveloping the Pharmalot campus. To celebrate, yes, we are brewing more cups of stimulation in our coffee kettle and working to the rhythm of the snoring mascots. As for you, here are some items of interest. We hope you find them helpful and, of course, that you have a smashing day …AstraZeneca reported that its Brilinta blood thinner failed to help stroke patients as hoped in a major clinical trial, Bloomberg News tells us. The drug was not significantly better than aspirin, which is the current standard of care, in preventing recurring heart attacks in the 90 days after patients suffered a stroke. The drug is a critical part of plans that call for reaching $45 billion in annual revenue by 2023.Despite a warning from Moody’s credit analysts, investors in bonds backed by risky loans are positive on deals involving Valeant Pharmaceuticals debt, The Financial Times writes. But not everyone is optimistic. “You’d need almost every market participant” in the (collateralized loan obligation) market to agree to a deal, Kevin Kendra, managing director and head of Fitch’s US Structured Credit group, tells Fortune.advertisement About the Author Reprints @Pharmalot Alex Hogan/STAT An Indian court agreed to a hearing next week concerning a government ban on 344 fixed-dose combination drugs, including a popular Pfizer cough medicine, The Hindustan Times reports. Meanwhile, India’s National Pharmaceutical Pricing Authority moved in to back the health ministry in its efforts to curb these drugs by returning more than 200 applications to drug manufacturers, The Economic Times informs us.Sanofi and Regeneron Pharmaceuticals reported a late-stage study of the Praluent injectable drug reduced the need for patients with an inherited form of high cholesterol to have bad cholesterol removed from their blood, Reuters says.Chinese authorities detained 37 people in Shandong province after a $90 million black market ring in vaccines was discovered last week, Reuters tells us. The vaccines — for meningitis, rabies and other illnesses — are suspected of being sold in dozens of provinces around China since 2011, and the government has promised a crackdown.Eli Lilly won US regulatory approval for an injectable drug called Taltz to treat adults with moderate-to-severe plaque psoriasis, according to The Wall Street Journal.A trial is under way in a Miami court where an insurer for Eli Lilly alleges Tyco failed to protect computer data that allowed thieves to break into a warehouse and steal $60 million of drugs in 2010, Security Sales & Integration says.Germany’s Institute for Quality and Efficiency in Health Care decided there is no evidence to cover an added benefit for Novartis’s Cosentyx to treat ankylosing spondylitis and psoriatic arthritis, PMLive writes. Ed Silverman By Ed Silverman March 23, 2016 Reprints Tags AstraZenecacystic fibrosisValeant Pharmaceuticals
Month: June 2021
By Associated Press Oct. 10, 2016 Reprints Heart attack patients are getting younger — and more obese About the Author Reprints Attention desk jockeys: Those who sit at work need an hour of exercise a day Tags exerciseheart attack Related: Should you simmer down before sweating it out? Robyn Beck/AFP/Getty Earlier studies have looked at anger and exertion as heart attack triggers, but most were small or in one country, or included few women or minorities. The new study involved 12,461 people suffering a first heart attack in 52 countries. Their average age was 58 and three-fourths were men.advertisement They answered a survey about whether they were angry or upset, or had heavy exertion, in the hour before their heart attack or during the same time period the previous day. That way researchers could compare risk at different times in the same people and the effect of these potential heart attack triggers.Being angry or upset doubled the risk of suffering heart attack symptoms within an hour; heavy physical exertion did the same. Having both at the same time more than tripled the risk for a heart attack.The risk was greatest between 6 p.m. and midnight, and was independent of other factors such as smoking, high blood pressure or obesity.Big caveats: Patients reported their own stress or anger, and people who just had a heart attack may be more prone to recall or think they suffered one of these triggers than they otherwise might have been. Also, strenuous exertion is whatever the patient perceives it to be — for some people that could be climbing stairs and for others, running a marathon. The study also is observational, so it cannot prove cause and effect. But it’s likely to be the best kind of information available — it’s not possible to randomly assign people to be angry and exercise, then see how many have heart attacks.“This is a large enough sample size that we can put stock in the findings,” Jacobs said.“We all need to find ways of modifying our emotional reactions and to avoid extreme anger,” such as distracting ourselves, walking away from the stressful situation, trying to see it from a different perspective, talking it out and getting support from other people, he said.The study’s findings also are biologically plausible. Emotional stress and exertion can raise blood pressure and heart rate, change the flow of blood in the vessels and reduce the heart’s blood supply, said the study leader, Dr. Andrew Smyth of McMaster University. In an artery already clogged with plaque, a trigger could block blood flow and lead to a heart attack. Related: If you’re angry or upset, you might want to simmer down before heading out for an intense run or gym workout. A large, international study ties heavy exertion while stressed or mad to a tripled risk of having a heart attack within an hour.Regular exercise is a healthy antidote to stress and can help prevent heart disease — the biggest problem is that too many people get too little of it. But the new research suggests there may be better or worse times to exercise, and that extremes can trigger harm.“This study is further evidence of the connection between mind and body. When you’re angry, that’s not the time to go out and chop a stack of wood,” said Barry Jacobs, a psychologist at the Crozer-Keystone Health System in suburban Philadelphia and an American Heart Association volunteer.advertisement HealthExercising while angry or upset could carry temporary heart risks, study says Does exercise prevent cancer? “From a practical perspective, there will be times when exposure to such extremes is unavoidable,” Smyth said.“We continue to advise regular physical activity for all, including those who use exercise to relieve stress,” but people should not go beyond their usual routine at such times, he said.The study was funded by the Canadian Institutes of Health Research, other governmental bodies from various countries that participated, and grants from several drug companies.— Marilynn Marchione Related: He had no role in the study, led by the Population Health Research Institute at McMaster University in Hamilton, Ontario. Results were published Monday in the Heart Association journal Circulation. Associated Press
Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED By Andrew Joseph May 16, 2017 Reprints GET STARTED General Assignment Reporter Andrew covers a range of topics, from addiction to public health to genetics. What’s included? What is it? Log In | Learn More He made the emotional plea to his colleagues: Pass this bill.“It might give somebody like my wife a chance to walk,” Texas Representative Drew Springer said through tears late Thursday at the state Capitol in Austin. “I’d trade every one of my bills I’ve passed, every single one of them, to get the chance to hear HB 810.” 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. Politics @DrewQJoseph 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. Tags policyresearchstates Andrew Joseph Three bills are under consideration in the Texas Legislature that would affect stem cell clinics and chronically ill patients. Dan Istitene/Getty Images About the Author Reprints [email protected] Texas leans into unproven stem cell treatments, to the dismay of scientists
About the Author Reprints Pharmalot Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. GET STARTED Ed Silverman 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. 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. Tags drug pricinglegalpharmaceuticalsSTAT+ By Ed Silverman Sept. 20, 2017 Reprints What’s included? [email protected] Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED @Pharmalot Pfizer accuses J&J of illegally stifling insurance coverage for its biosimilar Mark Lennihan/AP Underscoring the lucrative potential for biosimilars, Pfizer (PFE) has accused Johnson & Johnson (JNJ) of using anti-competitive practices to prevent insurers from covering its version of a best-selling J&J medicine.In a lawsuit filed on Wednesday, Pfizer claims that J&J used various illegal contracting tactics to convince insurers not to cover Inflectra, a biosimilar version of the blockbuster Remicade treatment for rheumatoid arthritis and other diseases. A biosimilar, you may recall, is a nearly identical variant of a brand-name biologic medicine and is expected to provide the same result in patients. Log In | Learn More 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] @NicholasFlorko WASHINGTON —The drug industry’s storied lobbying group isn’t accustomed to bad news — and with its small army of well-connected advocates, it’s even less familiar with surprises.For PhRMA, the news last winter was both. Washington Correspondent Nicholas Florko reports on the the intersection of politics and health policy. He is the author the newsletter “D.C. Diagnosis.” Log In | Learn More By Nicholas Florko Jan. 2, 2019 Reprints Special ReportHow PhRMA finally lost: the inside story of the group’s biggest lobbying failure in years 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? Nicholas Florko Mike Reddy for STAT About the Author Reprints GET STARTED What is it? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Tags Congressdrug pricinggovernment agenciesMedicarepolicy
Log In | Learn More 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. Biotech Vertex to pay startup Kymera $70 million in R&D deal Vertex Pharmaceuticals, the Boston biotech best known for its portfolio of drugs to treat cystic fibrosis, will pay $70 million up front to a Cambridge, Mass., startup that hopes to use a novel approach to treat diseases. It will initially focus on inflammatory disorders and cancers, but the science could potentially apply to a broad range of illnesses.Vertex announced a four-year research and development collaboration Wednesday with Kymera Therapeutics. The privately held startup wants to develop drugs based on Nobel Prize-winning insights into how the body eliminates disease-causing proteins. 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. Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED What is it? Jonathan Saltzman — Boston Globe GET STARTED About the Author Reprints What’s included? By Jonathan Saltzman — Boston Globe May 15, 2019 Reprints Scientists at work at Vertex Pharmaceuticals. Barry Chin/The Boston Globe Tags biotechnologyBostondrug developmentfinancerare diseaseSTAT+