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The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
FDA
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
Job Trends
Follow along as BioSpace tracks job cuts and restructuring initiatives.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
THE LATEST
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.
FDA
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.
Is there a connection between Bristol Myers Squibb’s announcement that it will reduce its headcount by 6% and the company’s recent acquisitions of Karuna, Mirati and RayzeBio?