Policy
Citing lack of evidence and manufacturing issues, the regulator has rejected Outlook Therapeutics’ bid to have its bevacizumab formulation approved for wet age-related macular degeneration.
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
Experts from U.S. health regulatory agencies have announced plans to conduct a clinical trial to assess the safety and efficacy of TPOXX (tecovirimat) as an antiviral for monkeypox.
In its Q2 conference call, Sarepta Therapeutics indicated plans to accelerate its timeline for SRP-9001 a gene therapy for Duchenne muscular dystrophy (DMD).
The debate over drug pricing tends to heat up during election season. With the mid-terms in November, we’re going through the cycle once again, sparked by provisions in the Inflation Reduction Act.
Whistleblowers Erika Cheung and Tyler Shultz discussed their experiences at Theranos during the recent 2022 AACC Annual Scientific Meeting & Clinical Lab Expo.
The FDA has placed a clinical hold on Beam Therapeutics’ leukemia/lymphoma therapy and has lifted the hold on Celyad’s CAR-T candidate for colorectal cancer.
The FDA granted Priority Review for omidubicel with a target action date of January 30, 2023. Omidubicel is a first-in-class, advanced NAM (nicotinamide)-enabled stem cell therapy.
The end of July is busy for the FDA, with Coherus, Sanofi, Acadia, Myovant and Pfizer having PDUFA dates filling the calendar. Here’s a look.
InMed updated its INM-755 for patients with epidermolysis bullosa, Seagen and Astellas announced positive topline results for Padcev with Merck’s Keytruda, and more.
The measures will allow San Francisco and New York to coordinate efforts across different agencies and raise the public’s awareness to curb the spread of monkeypox.
The probe will be led by investigators experienced in determining whether or not entities have defrauded consumers, investors or government agencies.