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An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
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Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Based on topline data, Pfizer stated that three doses of the COVID-19 vaccine met all immunobridging criteria required for EUA. The FDA’s advisory committee will meet June 15 to discuss the matter.
Sunday night, U.S. health authorities announced that they may have found the third documented case of monkeypox in a patient in South Florida.
Alnylam Pharmaceuticals shared 18-month results from its phase III Helios-A clinical study demonstrating that vutrisiran improves clinical cardiac symptoms in patients with hATTR.
On Wednesday evening, a man in Massachusetts became the first person reported to have a case of monkeypox in the U.S. The man contracted monkeypox after traveling to Canada.
U.K. researchers found that the first dose of any vaccine was linked with an initial 12.8% decrease in the odds of Long COVID.
Following reports that Pfizer has declined study requests for Paxlovid, the company and NIH are said to be in conversation about potential studies assessing a longer treatment period of the antiviral.
Greece’s Health Minister Thanos Plevris announced plans to sue Novartis over what he alleges are illegal practices. In addition to demanding compensation, the country is implementing a three-point plan.
Akebia Therapeutics’s partner Otsuka Pharmaceutical Co. announced plans to terminate its global license agreements with Akebia for vadadustat.
Clay Siegall resigned his role as president, CEO and a member of the board of directors of Seagen following domestic violence allegations. Roger Dansey will serve as interim CEO.
The changes are unlikely to help people in developing countries but could reduce innovation among biopharma companies and ultimately do more harm than good.