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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

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

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

The FDA’s fallout from its controversial approval of Biogen’s Alzheimer’s drug Aduhelm is rolling on with one pivotal Democratic lawmaker calling on the administration to dethrone the agency’s top decision-maker...Sen. Joe Manchin called on President Joe Biden in a letter...to oust the FDA’s interim commissioner Dr. Janet Woodcock...The moderate Democrat took aim at the FDA’s decision last week to approve Biogen’s Aduhelm, also known as aducanumab, for Alzheimer’s patients despite intense controversy over whether the treatment actually helps with cognitive decline...READ MORE

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 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

On December 30, 2020, the Department of Health and Human Services issued an advisory opinion on the 340B Program...This program limits the prices drug manufacturers can charge for therapies sold to specific healthcare facilities, including public hospitals and community health centers. The opinion was designed to address whether drugmakers could refuse to sell drugs to those pharmacies at the “ceiling price.”...AstraZeneca, Eli Lilly, Novo Nordisk and Sanofi turned around and sued HHS over the issue...HHS responded saying it “never intended to do what plaintiffs in those suits allege: to create new, binding obligations on plaintiffs or to serve as the predicate for enforcement against those plaintiffs.”...READ MORE

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

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

A senior manager in operations at Johnson & Johnson. A sales specialist at McKesson. A manager for international tax planning at Cardinal Health...What do these recent postings for remote jobs have in common?...All specify that those who live in Colorado need not apply...The issue, it seems, is Colorado’s Equal Pay for Equal Work Act, which requires companies to disclose the pay range for job openings. The goal of the new law, which went into effect on Jan. 1, is to narrow gender wage disparities by in part forcing salary transparency. Instead, companies that prefer not to disclose pay are barring remote workers from the state...READ MORE