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.
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The FY19 Defense Appropriation provides $3 million (M) to the Department of Defense Bone Marrow Failure Research Program (BMFRP) to support scientifically meritorious research focused on BMF diseases.
As drugmakers continue to develop an understanding of what pain is to the human body, it helps drive the development of innovative manners to treat it that transcend addictive options such as opioids.
The next couple of weeks look to be busy for the FDA, with a string of target action dates scheduled. This week marks three scheduled approvals, two for extra indications for already-approved biologics, and the third for a combination treatment for glaucoma. Here’s a look.
Sanofi has been hoping to secure approval from the U.S. Food and Drug Administration for its dengue vaccine, but a mixed review from a panel of experts could sink the chances of a green light for the medication.
The U.S. Food and Drug Administration (FDA) and some biosimilar and generic drug advocates were concerned that the naming for biosimilars—the branded drug’s name and a unique, four-letter suffix—made the drugs sound inferior to consumers than their branded counterparts.
Eisai Co., Ltd. has announced that a marketing authorization application has been submitted in Japan for lemborexant, an investigational agent for sleep-wake regulation, seeking approval for use in the treatment of insomnia disorder.
Perhaps the biggest mover and shaker announcement this week was the unexpected resignation of Scott Gottlieb, commissioner of the U.S. Food and Drug Administration. Gottlieb will leave his post later this month to spend more time with his family.
Gottlieb announced his intention to leave the FDA earlier this week. The Trump administration will have a list of candidates to choose from as it moves forward.
The European Patent Office has granted a patent for Sangui’s proposed technology/treatment (SBT 102) for septic shock patients, effective March, 6, 2019*.
Biotech and pharma companies from across the globe share data and news in a weekly roundup.