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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.
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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.
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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.
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A year after Roche returned Gavreto’s global rights to Blueprint Medicines, Rigel Pharmaceuticals has acquired the U.S. rights to the FDA-approved treatment for non-small cell lung cancer.
The biotech will use the oversubscribed Series C financing to advance its next-generation KRAS blocker FMC-376, which saw its first patient dosed in a Phase I/II clinical trial on Thursday.
Seeking a slice of the lucrative obesity market, Indian pharma companies are developing their own versions of Novo Nordisk’s blockbuster weight-loss drug Wegovy, Reuters reports.
The inspiration behind two blockbuster biopharma deals in 2023, anti-TLIA drugs have the potential to improve efficacy and durability of response for a number of autoimmune diseases, experts tell BioSpace.
ORI Capital announced Thursday that it has raised more than a quarter of a billion dollars for its second life sciences fund, which will invest in early-stage biotech companies using the firm’s proprietary AI-driven platform.
The settlement, which includes an upfront $75 million payment to Gavi, ends arbitration related to a 2021 advance purchase agreement involving Novavax’s prototype vaccine NVX-CoV2373.
Both Pfizer and Moderna surprised analysts with sales of COVID-19 vaccines and treatments, yet the companies still need to manage declining revenues in the years to come.
While COVID vaccine revenue dropped 43% compared to the same period last year, Moderna on Thursday reported a profit of $217 million which beat analyst estimates, driven by deferred payments and cost savings.
With the departure of AbbVie and AstraZeneca from the trade group, Pharmaceutical Research and Manufacturers of America has named new members to its leadership including Gilead Sciences chief Daniel O’Day.
After treatment with a CD19 CAR-T therapy, patients with systemic lupus erythematosus, idiopathic inflammatory myositis or systemic sclerosis achieved long-lasting remission, according to results published in the NEJM.