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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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Eisai Co., Ltd. has announced that the National Medical Products Administration of China has accepted for review a New Drug Application for Eisai’s antiepileptic drug (AED) perampanel as an adjunctive treatment for partial onset seizures in epilepsy patients 12 years of age and older. This NDA is the first to be submitted for perampanel in China.
ADOCIA announces that Eli Lilly and Company (“Lilly”) filed a complaint against Adocia in the United States District Court of the Southern District of Indiana on October 9th, 2018.
The Minnesota Attorney General is calling out Sanofi-Aventis, Novo Nordisk and Eli Lilly over alleged price gouging for insulin. This week Minnesota Attorney General Lori Swanson filed a lawsuit against the three companies over insulin price hikes.
AbbVie’s Humira is the world’s best-selling drug that generated more than $18 billion for the Illinois-based company last year. This week though, the company will begin to see challenges to Humira in Europe from biosimilars developed by Amgen and Novartis, as well as others.
“President Trump is taking historic action to bring patients more transparency through consumer advertising,” Azar said in a speech. “We are proposing to require American drug companies for the first time ever to include in their TV advertising the list prices of drugs paid for by Medicare or Medicaid.”
The National Institute of General Medical Sciences, part of the National Institutes of Health, awarded Allele Biotechnology and Pharmaceuticals a Small Business Innovative Research grant to develop therapies for sepsis.
The U.S. Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee voted to recommend AcelRx Pharmaceuticals’ Dsuvia to manage moderate-to-severe pain.
Things seem to have gone from bad to worse for Pennsylvania-based Trevena, Inc. This week the company saw a U.S. Food and Drug Administration advisory committee reject its intravenous pain treatment and now a class action lawsuit filed against the company claims Trevena executives have misled investors for years.
UH Biologist Discovers Protein Partnership That Protects Blood Vessels
Examples of new syndromes include hypotonia, ataxia, and delayed development syndrome (HADDS) and Sashi-Pena syndrome (SHAPNS).