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FDA Commissioner Robert Califf highlighted the role the biomedical “ecosystem” should play in reversing the decline in life expectancy in the U.S. in a Science magazine editorial last week. Read More
The number of drug manufacturing facilities registered with the FDA has grown by an average of 3 percent worldwide since 2018, according to the FDA Office of Pharmaceutical Quality’s 2021 report, with the U.S. surging ahead with a 5 percent increase in facilities. Read More
Pfizer will ask the FDA to approve its respiratory syncytial virus vaccine, RSVpreF, based on phase 3 data showing that it prevented about 86 percent of severe disease. Read More
The FDA issued a warning letter to Tramadol US, calling on the company to stop selling prescription drugs, including opioids, directly to consumers on the 25 websites the company operates. Read More
A federal judge in California has ruled that Gilead Sciences must face a pay-for-delay lawsuit over alleged unlawful payments to India-based Cipla to block competition for Gilead’s former blockbuster HIV drug Truvada (emtricitabine, tenofovir disoproxil fumarate). Read More
Indivior must face a federal jury over allegations that it tried to maintain its monopoly on Suboxone by switching to a sublingual formulation just as other companies were launching generic versions of the opioid antagonist. Read More
Controversy often arises around FDA’s drug approval decisions when the system fails to produce reliable evidence of risks and benefits, says FDA Commissioner Robert Califf, alluding to recent criticism of the agency for bypassing advisory committee recommendations. Read More
Paxlovid is authorized for treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older weighing at least 40 kg. Read More
Days after announcing a bankruptcy filing to restructure more than $8 billion in debt, Endo International has lost a long-contested patent lawsuit, piling more woes on the beleaguered company. Read More