Policy
Marty Makary, likely FDA commissioner under President Trump, appeared before Congress this week as the agency he’s set to lead continues to be rocked by sweeping changes and about-faces.
FEATURED STORIES
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
Having seen Congress spend money to onshore semiconductor production, pharma groups are pushing for similar incentives for domestic drug manufacturing.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Two months after winning FDA approval in the same indication, AbbVie and Genmab on Monday secured the European Commission’s nod for its bispecific antibody Tepkinly for the most common type of low-grade non-Hodgkin lymphoma.
Amgen’s Enbrel, Bristol Myers Squibb’s Eliquis and Johnson & Johnson’s Stelara will account for 51.4% of the Inflation Reduction Act’s drug price negotiation savings in 2026, according to the Brookings Institution.
In June, the regulator placed a partial clinical hold on a Phase I trial of the companies’ antibody-drug conjugate after three patient deaths were reported.
For the Biden-Harris administration to compare the newly announced negotiated Medicare prices to the list prices for these drugs is, at best, not very meaningful. At worst, it’s disingenuous.
Just months after a jury ordered payment to Pfizer in the patent infringement case, a Delaware judge has nullified the award and invalidated the patents behind the lawsuit involving AstraZeneca’s blockbuster lung cancer drug.
The Biden administration on Thursday touted discounts of up to 79%, but many of these first 10 drugs are already sold well below list price.
The Biden administration on Thursday announced that the Inflation Reduction Act’s Medicare Drug Price Negotiation Program will save the U.S. government around $6 billion in its first year of implementation.
The new Medicare prices for the first 10 drugs negotiated under the Inflation Reduction Act are expected soon. Analysts and researchers are divided on the long-term effects of the law.
The European Union has approved the first-ever combination therapy consisting of an immunotherapy and a PARP inhibitor for the treatment of endometrial cancer, AstraZeneca announced Wednesday.
As the U.S. moves away from reliance on Chinese CDMOs, Southern cities provide a model for how we can bolster domestic production capacity.