- 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>
- U.S. lawmakers to investigate approval, pricing of Alzheimer’s drug from Biogen (reuters.com)
U.S. lawmakers...announced an investigation into the approval and pricing of Biogen Inc's Alzheimer's drug, Aduhelm, amid concerns over its steep price and doubts if the clinical evidence proves the drug works...The drug, which has a list price of $56,000 per year, was approved by the U.S. regulators as the first treatment to attack a likely cause of Alzheimer's..."We have serious concerns about the steep price of Biogen's new Alzheimer's drug Aduhelm and the process that led to its approval despite questions about the drug's clinical benefit," House Committee on Oversight and Reform said in a statement...READ MORE
- Data Supports Use of Anti-Parasitic Drug Ivermectin in COVID-19 Patients, Study Shows (biospace.com)
Use of the anti-parasitic drug ivermectin could reduce COVID-19-related deaths, data from a peer-reviewed study shows...The study, published last week in the American Journal of Therapeutics, analyzed data from multiple clinical studies assessing ivermectin as a potential treatment for COVID-19. Ivermectin, which is approved by the U.S. Food and Drug Administration as a treatment for intestinal strongyloidiasis and onchocerciasis...The latest assessment of those multiple studies seems to confirm the potential of ivermectin against COVID-19. However, the FDA currently maintains a web page warning against the unauthorized use of ivermectin to treat the virus...The FDA notes that clinical studies are underway assessing ivermectin against COVID-19, but until those are reviewed and confirmed, it will warn against taking unauthorized medication...READ MORE
- Drug Diversion On Radar of the Joint Commission (pharmacypracticenews.com)
Consultants at Joint Commission Resources are urging hospitals to double down on efforts to keep controlled substances safe. This is in light of a Joint Commission finding that 10% of hospitals surveyed in 2019 did not meet medication security standards, including those meant to prevent diversion...Jeannell Mansur...PharmD, the principal consultant for medication management and safety at JCR..pointed to a range of medication management and storage gaps that leave controlled substances open to diversion in health systems...READ MORE
- 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
- 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...READ MORE
- S.Africa’s Ramaphosa accuses Big Pharma of ‘selfish, unjust’ vaccine policy (reuters.com)
South Africa's president said...the "selfish, unjust" refusal of pharmaceutical companies and allied Western governments to entertain emergency patent waivers on COVID-19 vaccines was endangering the entire world...In unusually impassioned remarks, Cyril Ramaphosa lambasted a resistance to calls by India and South Africa for temporary patent waivers to ramp up production...The proposed waiver from the WTO's agreement on Trade-Related Aspects of Intellectual Property Rights has support in principle from U.S. President Joe Biden and French President Emmanuel Macron...But the pharmaceutical industry is against the waiver, as are Germany, Switzerland and the World Bank. They argue it would stifle innovation and that vaccine supplies are constrained by a lack of manufacturing capacity...READ MORE
- Viatris scores a win in long-running EpiPen antitrust lawsuit, but patent settlement charge heads to trial (fiercepharma.com)
Generic giant Mylan has faced a slew of lawsuits targeting its EpiPen marketing strategies. Now known as Viatris, the drugmaker says it's scored a win against serious charges in an antitrust case that's been running for several years...The case dates back to 2017 when the plaintiffs...charged Mylan with a number of anticompetitive strategies to build and maintain its EpiPen empire...Mylan also paid excessive rebates to pharmacy benefit managers, commercial payers and state Medicaid programs as long as they didn't reimburse competing products, plaintiffs said. They further cited the well-known and dramatic price hikes Mylan implemented over the years...READ MORE
- CVS cut 72 drugs with ‘hyperinflated’ prices from its formulary last year (fiercehealthcare.com)
Posaconazole, an antifungal medication, is priced at $4,500 for a 30-day supply—while an alternative, fluconazole, costs less than $14...This is an example of a growing trend: medications, including many generics, with "hyperinflated" prices, experts at CVS Caremark say. The pharmacy benefit manager giant culled 72 such drugs from its formulary in 2020 alone, leading to savings of $1.2 billion compared to 2018...CVS first launched a program to address hyperinflated drugs in 2017, and it pulls drugs from its formulary when they have a far cheaper equivalent or if the price doesn't match up with quality metrics...READ MORE
- EXCLUSIVE: The 340B Program Soared to $38 Billion in 2020—Up 27% vs. 2019 (drugchannels.net)
Discounted purchases under the program reached at least $38 billion in 2020. That figure is an astonishing 27% higher than its 2019 counterpart—and more than quadruple the value of discounted purchases in 2014…The 340B program’s size now exceeds the Medicaid program’s outpatient drug sales—and accounts for nearly 20% of the total rebates and discounts that manufacturers provide for brand-name drugs. Alas, many elements of the 340B program—including its controversial contract pharmacy component—lack a comprehensive regulatory infrastructure…READ MORE