- Nevada’s execution drugs expiring as legal battle continues (apnews.com)
Nevada prison officials say one of the drugs they originally planned to use this month in the state’s first execution of an inmate in 15 years expires July 31. Another expires six weeks after a new evidentiary hearing a judge now has scheduled in October to decide if or when four-time convicted killer Zane Michael Floyd will receive a lethal injection...But Nevada’s lawyers said in new court filings two other drugs in the four-drug execution protocol they have submitted to the court are available at least through February...And state corrections’ officials told the judge before he ordered a delay in the execution on Monday that they have access to similar drugs that could substitute for the other two closest to expiration...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
- California jury clears CVS in generic drug overpayment case (fiercehealthcare.com)
A California jury has cleared CVS in a years-long lawsuit alleging the pharmacy giant overcharged them by more than $121 million for generic drugs...A group of insured pharmacy customers in six states filed suit against CVS Pharmacy in 2015, claiming that the company overcharged them and their insurers for generic drugs while charging low, flat-fee prices through a discount program for cash-pay customers...A federal jury in the court for the Northern District of California unanimously determined...day that the pharmacy chain did not violate statutes in the six states with its Health Savings Pass program...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
- 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
- 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
- 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
- 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
- Johnson & Johnson pays $230m to settle New York opioids case (theguardian.com)
Johnson & Johnson has reached a $230m agreement to settle an opioid lawsuit brought by the attorney general of New York state...“Johnson & Johnson helped fuel this fire, but today they’re committing to leaving the opioid business – not only in New York, but across the entire country...READ MORE
- FDA adds warning about rare heart inflammation to Pfizer, Moderna COVID shots (reuters.com)Pfizer, Moderna COVID-19 vaccines will get label warning over rare heart risk, FDA says (fiercepharma.com)
The U.S. drug regulator...added a warning to the literature that accompanies Pfizer Inc/BioNTech and Moderna COVID vaccine shots to indicate the rare risk of heart inflammation after its use...For each vaccine, the fact sheets for healthcare providers have been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with onset of symptoms within a few days after vaccination, the FDA said...READ MORE