Policy
The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Record Sales of $4.25 Million, Sales Growth of 42%, and Material Net Earnings
Under the terms of the deal, AbbVie will grant Germany-based Boehringer Ingelheim a non-exclusive license for Cyltezo, its biosimilar to Humira.
Bayer said the award conflicts with an April report from the EPA that says glyphosate, the active ingredient in Roundup, is not a carcinogen.
“With today’s FDA approval, Eylea has once again set a high bar for the treatment of diabetic eye diseases,” stated George D. Yancopoulos, president and chief scientific officer at Regeneron.
The drug was approved as a second-line treatment for HCC patients who have an alpha-fetoprotein biomarker.
The new guidance should allow switches from branded products to biosimilars that are alike in safety and efficacy without prescriber approval.
Insys owes more than $240 million in legal-related fees but the company only has about $87 million in available cash.
The two generic drugmakers, along with many others, have been accused of conspiring to inflate the price of more than 100 generic drugs.
May has been a fairly slow month for approvals by the U.S. Food and Drug Administration (FDA). There are currently only two scheduled for the rest of the month, with a third that has been withdrawn. Let’s take a look.
Companies that generate revenue less than $100 million would not have to undergo regular outside audits.