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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During the first presidential debate of Democratic candidates vying for that party’s presidential nomination, it didn’t take long for the pharma industry to take center stage.
BioTek’s Synergy™ Neo2 Hybrid Multi-Mode Microplate Reader received expanded certification from Cisbio Bioassays for their proprietary HTRF® technology, a TR-FRET assay platform used in the Life Sciences.
The nation’s drug development efforts have been given additional momentum with the introduction of two new platforms, and a grant scheme for drug discovery and development.
The FDA said the companies marketed the herbal extract with unproven claims. Kratom has not been approved by the FDA for any use.
The Management Board of MagForce AG has resolved and successfully completed, with the approval of the Supervisory Board, on basis of the authorization provided for in the Company’s articles of association, an increase of the registerd share capital of the Company from currently EUR 26,463,802.00 to EUR 27,640,274.00 by issuing 1,176,472 new no-par value bearer shares under exclusion of the shareholders’ statutory subscription rights.
Premark Pharma announced the completion of a licensing deal with Novartis Pharma AG, granting Premark exclusive worldwide rights to develop and commercialise PMP2207, an ophthalmic ointment formulation, as a potential treatment for blepharitis.
In a statement, WHO said it was discontinuing two guidelines that have been in place since 2011 and 2012 “in light of new scientific evidence that has emerged since the time of their publication” regarding the dangers of opioid abuse.
The partial clinical hold was lifted after the company revised the study protocol for the trial. The partial clinical hold remains on other multiple myeloma trials involving venetoclax.
Glenmark said it should be able to resolve the FDA’s concerns within six to nine weeks and will work with the regulatory agency toward approval.
July looks to be a quiet month for the U.S. Food and Drug Administration (FDA), and it sure looks like the agency is trying to get a lot of work done before the July 4 holiday. Here’s a look at the many approvals scheduled for this week.