News
While the FDA did not announce the recipient names of the Commissioner’s National Priority Vouchers, the agency’s descriptions of the awarded products match those in development at Compass Pathways, Transcend Therapeutics and Usona Institute.
FEATURED STORIES
The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
With a greenlight for ibogaine to enter clinical testing and three unnamed products set to receive Commissioner’s National Priority Vouchers this week, it’s full speed ahead for psychedelics. But will sidestepping normal regulatory protocols actually be a net negative for the field?
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
THE LATEST
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the importance of target product profiles, particularly when navigating funding challenges, with Ian Fisher, head of development analytics.
Looking for a manufacturing job? Check out the BioSpace list of 11 companies hiring life sciences professionals like you.
Nine states in the Southeast showed growth in bioscience employment and establishments from 2019 to 2023, according to 2024 data from BIO and TEConomy Partners. NCBiotech and Bexion executives discuss the area and the pros and cons of setting up shop far from major hubs.
Canada’s health agency says it has been “taking all necessary action safeguard the drug supply and ensure Canadians have access to the prescription drugs they need.”
The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in patients with prostate cancer who do not carry HRR mutations.
The FDA had given Pfizer and Moderna until May 17 to propose changes to the labels of their COVID-19 vaccines or challenge the agency’s directive. The products’ labels already include myocarditis warnings, albeit for different age groups.
The CMS last month declined to include anti-obesity medications in its Medicare coverage for Part D, a move that Lilly says could interfere with patients getting the appropriate medical care.
The deal helps revitalize the TREM2 target after the high-profile failure of AbbVie and Alector’s candidate last year.
After discussions with the FDA, Moderna has withdrawn its application for a combination shot, which had demonstrated efficacy in eliciting antibodies in data announced earlier this month.
BioSpace’s NextGen companies are rising in one of the most confounding biotech markets ever experienced. Executives sounded off on how to keep your head above water during our webinar, Are We There Yet?