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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It is the first and only nasally-dosed glucagon, which is indicated for diabetic patients undergoing a severe drop in blood sugar. Previously it was only administered by a complicated injection system.
Horizon Discovery Group plc, a global leader in the application of gene editing and gene modulation technologies, provides a trading update for the six month period ended 30 June 2019.
Double-digit sales growth delivered by Pharma Biotech & Nutrition (LPBN) segment
Expansion to bioconjugation facility in Visp, Switzerland to meet increasing clinical, launch and commercial market demand
Patents and intellectual property protections are a big deal in the biopharma industry. One reason is simply the timeline of drugs and therapeutics. Biopharma has several unique challenges, but one of them is the patent cliff.
As 2019 enters its second half, BioSpace takes a look at some of the warning letters issued by the U.S. Food and Drug Administration to the biopharma industry.
The FDA advisory committee canceled the meeting after Intra-Cellular provided the regulatory agency with additional data. No new meeting date has been scheduled.
Braeburn has been fighting the FDA over its award of Orphan Drug Designation to another opioid use disorder treatment that will prevent competition through November 2020. More than 2 million people in the U.S. have been diagnosed with the disease.
FDA’s Sharpless Outlines Agency’s 4 Top Priorities: Tech, Hiring, Modernization and Increased Safety
In terms of modernizing frameworks, Sharpless focused on the agency’s efforts to approve generic drugs and biosimilars more quickly in order to lower drug prices. He also said the FDA needed to help the biopharma industry with “the most expensive part of drug discovery and development,” referring to clinical testing.
It is approved for adults with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.