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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Teva Pharmaceuticals recalled 35 lots of bulk Losartan Potassium after a known carcinogen was discovered in the active pharmaceutical ingredient.
NHS England will acquire hepatitis C drugs from the companies at competitive prices and work to identify patients around the country.
The U.S. Department of Health and Human Services Office of the Chief Technology Officer and the American Society of Nephrology have selected 15 winning teams for Phase 1 of the KidneyX Redesign Dialysis prize competition.
BioArctic AB to publish the company’s Interim Report for the period January – March 2019 on Thursday, May 9, 2019 at 08:00 a.m. CET.
uBiome said it “does not have any control over physician billing. Any improper billing by physicians, if it occurred, is not related to uBiome’s billing practices,”
Four biotech companies recently filed with the U.S. Securities and Exchange Commission their plans for initial public offerings (IPO). Let’s take a look.
The NDA was based on positive Phase III data that shows the once-a-month treatment is as effective as the daily standard of care.
Ireland-based Horizon Pharma reported additional statistically significant secondary data from its positive Phase III study at a conference and plans to continue to share analysis at future medical conferences.
This week has a number of approvals expected by the U.S. Food and Drug Administration. Let’s take a look.
In September 2018 a leap forward in treating burn victims was made with the approval of Avita Medical’s RECELL Autologous Cell Harvesting Device. The Food and Drug Administration (FDA) green lit the California-based company’s burn treatment device that uses a small amount of a patient’s own skin to prepare what is called Spray-On Skin Cells.