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.
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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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The advisory committee voted 14 to 2 that the benefits of the drug did not outweigh the risks to support approval. The FDA is not obligated to follow the recommendation, but typically do.
The letter outlines multiple failures, including failure to have adequate written procedures for the receipt, identification and handling of raw materials and failure to adequately clean equipment and utensils.
The agency found that more than 2.8 million antibiotic-resistant infections occurred in the U.S. each year, killing more than 35,000 people.
Promore Pharma AB, a Swedish biopharmaceutical developer of therapeutic peptides, announced that its subsidiary Pergamum AB was granted a patent in the US for the pharmaceutical formulation of the product candidate PXL01.
The ISO 13485 audit is an essential qualification for medical device manufacturers, showing HRA Pharma’s commitment to the highest quality standard.
Second Orphan Drug Designation granted by the European Commission for leriglitazone, in addition to X-linked adrenoleukodystrophy (X-ALD)
H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act (cited as the Lower Drug Costs Now Act of 2019), is a bill before the House that is intended to make prescription drugs more affordable for those in the Medicare program.
In its announcement, Solid Biosciences said a patient in its second cohort who was dosed in October experienced a serious adverse event that was deemed related to the drug.
In Phase 2b development for the treatment of life-threatening fungal infections
Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration has approved QLETLI® for all eligible indications of the reference product, Humira®, in China.