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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The U.S. Food and Drug Administration approved another biosimilar. On Friday, the regulatory agency approved Herzuma, a biosimilar to Genentech’s Herceptin developed by South Korea-based Celltrion, Inc. and Israel-based Teva Pharmaceuticals.
Fidelta Ltd is pleased to announce that it has signed an integrated drug discovery agreement with Galapagos based on Fidelta’s macrocyclic platform.
Axovant Sciences, announced that it has licensed exclusive worldwide rights for the development and commercialization of two novel gene therapy programs to address GM1 gangliosidosis and GM2 gangliosidosis from the University of Massachusetts (UMass) Medical School.
As the holidays approach, the U.S. Food and Drug Administration (FDA) is getting in a few drug approvals to wrap up the year. This week there are two decision dates, with another that has been delayed for several months. Here’s a look.
The rule could have allowed generic manufacturers to independently update safety data on drugs, which could have opened the companies to potential lawsuits over side effects.
In writing literally hundreds of stories this year, two BioSpace writers, Alex Keown and Mark Terry, found certain stories particularly intriguing or impactful. Some of those were such big topics that they were covered over a series of stories. Looking back at 2018, here are their Top 10.
Earlier this week, the U.S. Food and Drug Administration cleared the company’s Investigational New Drug Application to allow the company to initiate clinical studies with Xeno-Skin, a product designed to provide help for patients who have suffered from significant burns.
As we look back over the year, we noticed some stories just grabbed readers more than others. Here’s a look at the top 10 stories of the year, including job cuts, best-selling drugs, up-and-coming companies,scandals, clinical trials, and more.
There are plenty of great scientific research stories out this week. Here’s a look at just a few of them.
Lawsuit Charges FDA, NIH With Failing to Follow Established Law for Reporting of Clinical Trial Data
The lawsuit alleges that the government is letting a number of researchers off the hook of reporting clinical data.