Policy
A U.S. federal court upheld a prior ruling in favor of Roche’s Genentech, finding that its blockbuster hemophilia treatment Hemlibra did not infringe on patent protections held by Takeda’s Baxalta.
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.
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Biden issued an executive order to keep U.S.-based innovation ahead of advances made by counterparts in China biotechnology and biomanufacturing Monday.
A Manhattan court dismissed a whistleblower lawsuit against Novartis, which had alleged the company paid doctors to promote its multiple sclerosis drug Gilenya.
Pres. Joe Biden vowed to bolster the U.S. biotechnology sector after signing an executive order to improve the fight against cancer.
President Joe Biden tapped Ginkgo Bioworks veteran Renee Wegrzyn to helm the recently-established Advanced Research Projects Agency for Health (ARPA-H).
The FDA is heading into fall with a few Prescription Drug User Fee Act (PDUFA) dates. Here’s a look at this week’s upcoming action.
Although it was a short week due to the Labor Day holiday, the FDA maintained a steady pace of business.
A new report has shed light on some pharmaceutical companies’ attempts to circumvent federal anti-kickback statutes by profiting from large donations to patient assistance organizations.
Wednesday evening, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 7-2 to recommend approval of Amylyx ALS candidate AMX0035.
Thousands of FDA employees may lose their jobs if Congress doesn’t reappropriate funding currently in place by the end of the month.
The FDA removed the clinical hold on Sarepta’s investigational treatment for certain types of DMD after the company agreed to adjust its clinical trial protocols.