Archive for August 2022

Combined with talk therapy, two strong doses of psilocybin – the active chemical of “magic mushrooms” – reduced heavy drinking by 83 percent, significantly more than when subjects just had therapy alone, according to researchers at NYU Langone University. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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). Source: Drug Industry Daily

Novartis spin-off Alcon will pick up Aerie Pharmaceuticals, expanding Alcon’s eye care products focus into the prescription pharmaceuticals arena. Source: Drug Industry Daily

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. Source: Drug Industry Daily

The role of FDA advisory committees is “malleable” and the public would trust the FDA more if the agency aligned its decisions on drug approvals with the decisions by the expert panels. Source: Drug Industry Daily