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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Public perception of the industry can be a bit confusing. Life Science Leader recently pulled together several biopharma executives for a round table discussion of the biopharma industry’s public perception—generally bad—and what might be able to do about it.
It’s not a secret to say that tax incentives play a significant role in a municipality’s ability to attract new businesses. In Massachusetts, a state with a heavy biotech presence, tax incentives have been able to help small towns compete with large biotech and pharma hubs, like Cambridge.
The CRL is not totally unexpected, given that last month the company received a multi-disciplinary review (DR) letter from the FDA regarding its New Drug Application.
The U.S. Food and Drug Administration (FDA) approved ADMA Biologics’ Asceniv to treat Primary Humoral Immunodeficiency Disease (PIDD or PI) in adults and adolescents.
Evotec SE announced that it has completed its conversion into a company under European law with its registration in the commercial register of the District Court of Hamburg.
The lynchpin to biotech and pharmaceutical drug development in the United States is arguably the greater Boston area, which includes the white hot square mile of talent and intellectual collaboration found in Kendall Square.
Eisai Co., Ltd. announced that in the 8th meeting of the Data Safety Monitoring Board for the global Phase III clinical studies on the investigational oral BACE inhibitor elenbecestat in early Alzheimer’s disease, the DSMB reviewed safety data including the potential for decline in cognition, and recommended the continuation of the studies.
There are three companies looking for decisions by the U.S. Food and Drug Administration (FDA) this week. All three drugs are either resubmissions or have had to deal with various problems related to manufacturing or incomplete data. Here’s a look.
Cambridge, Mass.-based Sarepta Therapeutics announced data from its interim analysis of muscle biopsy endpoints of its therapy casimersen for Duchenne muscular dystrophy (DMD). The interim data was strong enough to support a probable New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) by mid-year.
Gottlieb said the FDA believes there should be a premarket demonstration that a new opioid is superior to an already-approved opioid.