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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Sanofi is pressing the U.S. Food and Drug Administration to keep its patient experience data consistent following a review of approved applications required by the 21st Century Cures Act.
Motif Bio plc announced that the Company has received the official minutes of the Type B meeting with the U.S. Food & Drug Administration which took place on September 19, 2019..
New DAS organization within cluster reflects changes in health ecosystem and integrates techno-therapies
Heidelberg Pharma AG reported on the first nine months of fiscal year 2019 and the Group’s financial figures.
Researchers found that an injectable hormone called tesamorelin decreases liver fat and prevented liver fibrosis in this patient population.
The U.S. Food and Drug Administration approved Janssen Pharmaceutical’s Xarelto for the prevention of venous thromboembolism, or blood clots, in acutely sick patients in hospitals who are at risk for blood clots but who are not at high risk of bleeding.
The U.S. Food and Drug Administration approved Eli Lilly’s Reyvow (lasmiditan) for the acute treatment of migraines.
In September, House Speaker Nancy Pelosi unveiled a plan to lower prescription drug prices covered by government-funded plans that include tying those medications to an International Pricing Index – a move the pharmaceutical industry opposes wholeheartedly.
The U.K. government is working to ensure adequate quantities of medications and medical devices are on hand for the transition period that will follow any form of Brexit. As for the life sciences and biotech industries – it’s become increasingly clear they face acute disruption as a result of this period of uncertainty.
BioCardia announced renewal of the CE Mark for the Helix™ Biotherapeutic Delivery Catheter and Morph® Universal Deflectable Guide Catheter, both used in the delivery of biotherapeutics to the heart.