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. Government is increasing the measures it is taking to counter what it sees as a growing threat to scientific intellectual property from China.
Moving into the holidays and the fast-approaching end of the year, the U.S. Food and Drug Administration (FDA) got busy wrapping up a number of to-do items. Here’s a look.
At the Drug Development Unit at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust in London, the first patient in Phoenix’s first in human “ACTivate Trial” has received ACT® in combination with chemotherapy for treatment of hepatic metastases associated with colorectal and pancreatic cancer.
Reston Hospital has received verification as a Level II Trauma Center by the American College of Surgeons for a period of three years through the year 2022.
“Today’s announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients,” said Alex Azar, Secretary of HHS.
The FTC alleges that Illumina is trying to unlawfully maintain a monopoly in the U.S. market for next-generation DNA sequencing systems by removing PacBio as a competitive threat.
Follows recent study results showing CelGro® facilitates high quality nerve repair and restores function to previously paralysed muscles
Baebies is pleased to announce that FINDERTM, a near-patient testing platform, now has CE Mark as an In Vitro Diagnostic device and is commercially available in Europe and other countries that recognize CE Mark.
With the latest approval, Xtandi, an androgen receptor inhibitor, is now the only oral treatment approved by the FDA for three distinct types of advanced prostate cancer – non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mCSPC.
If approved by the European Commission, the daratumumab-VTd regimen would represent the first therapeutic option indicated for newly diagnosed patients who are eligible for a stem cell transplant in six years