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Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been implemented across all therapeutic areas before now.
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Alternatives to opioids are desperately needed to better treat moderate to severe acute pain, but to date, we’ve seen few novel analgesics hit the market.
LB Pharma needed $350 million to advance a promising schizophrenia candidate at a time when the biotech markets were locked up tight. Fortunately, it wasn’t CEO Heather Turner’s first rodeo.
Rare disease drug developers struggle to survive in a biopharma investment market that prioritizes large patient populations. Initiatives like the Orphan Therapeutics Accelerator are attempting to solve what CEO Craig Martin says is not a science problem, but a math problem.
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Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
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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.