News
The FDA’s extension will give reviewers more time to review a major amendment to Biogen and Eisai’s application for a subcutaneous induction formulation of Alzheimer’s therapy Leqembi. The new target action date is on Aug. 24.
FEATURED STORIES
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
THE LATEST
After a record low in 2022, the pharma industry in 2023 saw a surprise rebound in productivity following one of its slowest years on record, according to a report from audit firm Deloitte.
A one-fifth dose of Bavarian Nordic’s mpox vaccine Jynneos can elicit a similar antibody response as its standard-dose regimen, according to findings presented Saturday at the European Society of Clinical Microbiology and Infectious Diseases Global Congress.
With its first-in-class endothelin and angiotensin II receptor antagonist Filspari, Travere Therapeutics is providing a more efficacious treatment option for the rare autoimmune disease.
With GLP-1 agonists slated to become the best-selling drugs in 2024, the biopharma industry is already pivoting to explore treatments that preserve muscle mass as patients shed pounds.
Humira maintained its blockbuster status and market share dominance in the first quarter of 2024, but experienced a drop in sales as biosimilar competition heated up, AbbVie reported on Friday.
Gilead on Thursday reported revenue growth in the first quarter of 2024, driven by the strong sales of its HIV, cancer and liver diseases franchises, while culling a number of candidates.
Starting in June 2024, Evernorth Health Services will offer Humira biosimilar products with no out-of-pocket cost through its Accredo specialty pharmacy.
With its lawsuit filed against Pfizer and BioNTech, the British multinational biopharma has joined the high-profile patent battle over mRNA technology used in COVID-19 vaccines.
Pfizer will go toe-to-toe with CSL Behring following the FDA’s Friday approval of its hemophilia B gene therapy Beqvez and will launch a warranty program based on the durability of response.
The genetic engineering startup, recently honored by BioSpace readers for its work environment, is downsizing as it seeks to launch its first clinical trials.