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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As a student at a private school in Houston, Elizabeth Holmes had a reputation for being determined to accomplish her goals, no matter if she came in dead last. She was also notoriously private about her life.
With its concerns over drug pricing and potential questions of “pay-to-play” for access to the White House, Congress did not miss the chance to question President Donald Trump’s former attorney about his relationship with Novartis.
GENFIT, a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, announces the filing of its 2018 Registration Document with the Autorité des marchés financiers.
NOXXON Pharma N.V. announced that it has filed the clinical trial application (CTA) with the Federal Institute for Drugs and Medical Devices, to start a Phase 1/2 clinical trial combining NOX-A12 with radiotherapy to treat newly diagnosed brain cancer patients who would not benefit from the current standard of care and whose tumor cannot be fully resected by surgery.
Pyoderma Gangraenosum is a debilitating, rare autoimmune disease marked by large, painful ulcers
BioSpace gathered together a roundup of global biopharma news from the past week. Bayer and Orion Corporation, Themis Bioscience, Axonics Modulation Technologies, and more are mentioned in this edition.
Could a product in a weed killer contribute to the development of a cancer? That is the question a jury will answer as Bayer faces accusations that glyphosate, the active ingredient in its top=selling weed killer Roundup, caused cancer in some individuals who have used the product.
Shares of Adamis Pharmaceuticals are down nearly 5 percent this morning after the company announced late Tuesday that the U.S. Food and Drug Administration rejected its sublingual tadalafil product for erectile dysfunction, an alternative to the blockbuster Cialis.
FDA Commissioner Scott Gottlieb said the agency has changed its approach to the opioid crisis and will take a more aggressive approach on regulatory actions.
Shares of Karyopharm Therapeutics are crashing again after an advisory panel from the U.S. Food and Drug Administration recommended delaying potential approval of the company’s experimental multiple myeloma treatment until additional data is available from an ongoing Phase III study.