- Activist Investors Seek to Steer Control of Phoenixus Away from Jailed “Pharma Bro” (biospace.com)
Although Martin Shkreli has been behind bars for years due to a conviction for investment fraud, the man known as “Pharma Bro” has remained active running the former Turing Pharmaceuticals from his jail cell. However, that could change if some activist investors...have their way...Turing is the company that gained infamy after acquiring the decades-old toxoplasmosis drug Daraprim and raising the price by 5,000%. When Shkreli’s Turing Pharmaceuticals acquired Daraprim, the cost of a single pill was about $13.50. Turing increased the price to $750 per tablet, which drastically raises the cost of treatment for patients...READ MORE
- Study: Medicare spent billions more on generics than Costco due to distribution inefficiency (fiercehealthcare.com)
Medicare Part D spent $2.6 billion more in 2018 on generic drugs compared to Costco, likely due to the inefficient distribution system...The study published...in the Journal of the American Medical Association focuses on how intermediaries in the generic drug supply chain may be driving up costs for Medicare. In 2018, 88% of Medicare Part D prescriptions were for generic drugs, the study said...“Our analysis highlighted the inefficiencies the current system introduces through its complex and opaque system of intermediaries, which Costco largely bypasses,”...READ MORE
- U.K. Supreme Court rejects NHS claim of €220M financial loss in Servier patent lawsuit (fiercepharma.com)
In the culmination of a 10-year case, the U.K. Supreme Court has ruled in favor of Servier Laboratories in its defense against England’s National Health Service over a patent on cardio drug Coversyl...The lawsuit surrounded the French pharmaceutical company’s alleged attempt to block the sale of generic versions of Coversyl by defending a patent that the company knew was not valid. The NHS claimed that Servier caused the government financial loss by deceiving the European Patents Office and the courts and sought €220 million ($300 million) in damages...By a unanimous vote, the court ruled in favor of Servier...READ MORE</strong>
- Teva reaches $925K settlement with Mississippi in price-fixing case—and it hopes other states will follow suit (fiercepharma.com)
After years of facing allegations of price-fixing on a massive scale, Teva Pharmaceuticals has agreed to settle with the state of Mississippi for $925,000. That "modest" sum could be just the tip of the iceberg...The case dates back to 2019 when Mississippi, along with 43 other states, sued 20 generic drugmakers for divvying up markets and setting prices...it seems states are breaking away from the coordinated effort. Teva’s Mississippi settlement, filed in Pennsylvania federal court on Monday, marks the first agreement the Israeli drugmaker has inked as part of the larger price-fixing debacle...READ MORE
- FDA expected to announce new warning on Johnson & Johnson vaccine related to rare autoimmune disorder (msn.com)
The Food and Drug Administration is preparing to announce a new warning for the Johnson & Johnson coronavirus vaccine saying the shot has been linked to a serious but rare side effect called Guillain-Barré syndrome, in which the immune system attacks the nerves...About 100 preliminary reports of Guillain-Barré have been detected after the administration of 12.8 million doses of Johnson & Johnson vaccine in the United States, the Centers for Disease Control and Prevention said in a statement Monday. The cases have largely been reported about two weeks after vaccination and mostly in men, many aged 50 and older...READ MORE
- Pharmas’ return on $5B spent yearly on patient support programs? Only 3% are using them: survey (fiercepharma.com)
Talk about a meager return on investment. Pharma companies spend more than $5 billion on patient support programs every year, but when it comes to uptake, only 3% of patients are actually using them, according to a new survey from Phreesia Life Sciences...Taking into account people who have ever used any patient support program, the percentage ticks up a bit, but still only gets to 8%. Phreesia, a patient intake platform at point of care, conducted the survey with almost 5,000 people...So why the low usage? Lack of awareness is one clear factor—fewer than one-fourth (23%) of patients said they were extremely or very familiar with patient support programs, while another 18% said they were somewhat familiar...READ MORE
- Supreme Court agrees to hear hospital lawsuit challenging HHS’ 340B cuts (fiercehealthcare.com)
The Supreme Court agreed to hear a major dispute between the hospital industry and the federal government over cuts to 340B hospitals...The court agreed to hear the case during its next term that begins in October...A decision could be rendered sometime next year...The case called American Hospital Association v. Becerra centers on the Medicare reimbursement rate paid for outpatient drugs and whether the Department of Health and Human Services singled out 340B-covered entities...READ MORE
- Biden Order Revisits Trump Answers on Drug Prices, Competition (news.bloomberglaw.com)Executive Order on Promoting Competition in the American Economy (whitehouse.gov)
President Joe Biden
President Joe Biden‘s executive order on competition resurrects Trump administration policy plays geared toward cutting down drug prices, calling for efforts that policy analysts say may face challenges getting off the ground...The executive order signed Friday includes measures to bolster health-care industry competition in the interest of lowering drug prices. Among its proposals are a push for the Food and Drug Administration to work with states to import prescription drugs from Canada and a call for the Federal Trade Commission to crack down on brand drugmakers paying generic manufacturers to delay putting their cheaper products on the market...READ MORE
- Pfizer victory in Vyndaqel copay lawsuit could kneecap the government’s only control on prices, lawyer warns (fiercepharma.com)
After coughing up nearly $24 million in a federal settlement over donations to patient charities, Pfizer went on the offensive last summer and took the U.S.' anti-kickback policies to task. Late last month, the drug giant got its day in court...The company, angling to help Medicare patients pay for its costly heart drugs Vyndaqel and Vyndamax, recently challenged U.S. copay and kickback policies in New York federal court...a Pfizer win...could spur drug pricing fallout across the industry...Pfizer last June sued HHS in a bid to assist patients with their Medicare copays for two costly new medicines. U.S. kickback laws currently forbid drugmakers from helping patients with those costs...Pfizer is battling for the go-ahead on two programs. The first would allow the company to offer copay support directly to Medicare patients on its tafamidis meds Vyndaqel and Vyndamax, which run for $225,000 a year before rebates. The second would allow it to fund an independent charity to help with copays...READ MORE
- Pfizer Pauses Global Sales of Smoking-Cessation Drug Chantix Over Possible Carcinogen Contamination (biospace.com)
Pfizer announced it is pausing the distribution of Chantix (varenicline), its drug to help people stop smoking, after identifying increased levels of nitrosamines in the pills. Nitrosamines are potentially cancer-causing agents. The company is also recalling several lots of the drug...In 2020, the U.S. Food and Drug Administration found high levels of NDMA (N-nitrosadimethylamine) in some formulations of the diabetes drug metformin and had also reached out to Pfizer and other companies over NDMA in unacceptably high levels in a variety of drugs. In 2019, Sanofi's heartburn medication Zantac was recalled over NDMA contamination...READ MORE