Policy
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.
FEATURED STORIES
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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
September has been a relatively slow month for the U.S. Food and Drug Administration. However, there are two PDFUA dates remaining, although one of those took an unexpected turn that will delay it until later in the year.
Nucala is the only targeted biologic to be approved for the condition in the six to 11-year age group in the United States, the company said.
Silence Therapeutics, PLC announces its unaudited interim results for the half year to 30 June 2019.
Kaiser Health News recently published “Pharma Cash To Congress,” a campaign contributions tracker. KHN noted that, “Members of Congress raked in almost $4 million from the pharmaceutical manufacturers and their trade groups in the first six months of 2019.
Purdue Pharmaceuticals has reached a tentative settlement in thousands of opioid cases that could cost the company about $12 billion, but some litigation against the firm is expected to continue over its role in the opioid crisis.
Received Notice of Allowance from United States Patent and Trademark Office -- Received “Intention to Grant” notice from European Patent Office
Advanced Medical Solutions Group plc announces its unaudited interim results for the six months ended 30 June 2019.
Pharma stock prices took an across-the-board tumble Tuesday after Speaker of the House Nancy Pelosi unveiled a working plan to lower the prices of 250 of the most expensive drugs covered by Medicare and other government-funded programs.
The approval marks the first commercial product for Xeris.
Ultragenyx Pharmaceutical Inc. and Kyowa Kirin Co., Ltd. announced plans to submit a supplemental Biologics License Application to the U.S. Food and Drug Administration for Crysvita® for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized.