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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?
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.
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.
Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
THE LATEST
The FDA will kick off March with three target action dates, including one for an insomnia treatment and another for a multiple sclerosis therapy.
Eli Lilly is planning to launch its blockbuster diabetes drug Mounjaro next year in India, the world’s most populous nation, ahead of its main competitor Novo Nordisk which is eyeing an Indian launch of Wegovy in 2026.
Sarepta Therapeutics on Wednesday called the launch of the gene therapy for Duchenne muscular dystrophy “exceptional” but the company does not expect to see significant growth in the first half of 2024 due to its currently limited patient pool.
Incannex Healthcare on Wednesday said its investigational psychedelic psilocybin met the primary endpoint, demonstrating it can reduce Hamilton anxiety scores by more than nine points versus placebo.
On Wednesday, the CDC’s Advisory Committee on Immunization Practices voted to recommend Valneva’s chikungunya virus vaccine Ixchiq for certain high-risk patient groups.
This episode explores the drug pricing gap between consumer experience and industry norms. Join Lori and our KOLs as we explore the drivers of healthcare costs, the CBO, rebates, and overall spend in this new series.
Congressional legislation seeks to “equalize” the negotiating period between biologics and small molecules under the Inflation Reduction Act’s Drug Price Negotiation Program.
Electronic consent can personalize the patient experience in clinical trials and even improve retention. At Medable, where I am CSO, we’re committed to driving the adoption of this transformative technology.
Under the research and development agreement announced Wednesday, Viatris is securing global rights to Idorsia’s late-stage heart and lupus candidates.
The vaccine maker’s fourth-quarter revenue and earnings on Wednesday missed Wall Street expectations, while providing full-year 2024 sales guidance of flat to lower than last year.