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Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
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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.
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Following a patient case of severe liver enzyme elevations, Inventiva is suspending its Phase III NATiV3 study in non-alcoholic steatohepatitis as Madrigal Pharmaceuticals awaits a March 14 PDUFA date.
The progression-free survival metric has helped shepherd many products across the regulatory finish line. Experts say the FDA’s new emphasis on overall survival will be felt especially by small biotechs.
Claiming that Karuna Therapeutics’ board of directors withheld crucial information, a shareholder has filed a lawsuit seeking to block the $14 billion merger with Bristol Myers Squibb.
Kelonia Therapeutics’ in vivo gene placement system is being tapped to help Astellas Pharma expand its portfolio of in vivo CAR-T cell therapies for cancer.
While Gilead Sciences did not provide specific reasons for the halt, the company said it is “reviewing the benefit-risk” of its anti-CD47 antibody magrolimab across all ongoing trials.
In the next two weeks, the FDA is set to decide on a Humira biosimilar and a treatment for the negative symptoms of schizophrenia.
The French drugmaker Thursday touted trial results in The New England Journal of Medicine showing frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis.
Co-founded by Nobel Prize winner Carolyn Bertozzi, Firefly’s venture funding is backed by Eli Lilly and Versant Ventures, among others, to support its novel platform for merging antibody-drug conjugates with protein degraders.
Freenome announced Thursday a fundraising round of more than a quarter of a billion dollars, led by Roche, to advance its blood-based cancer tests as pivotal readouts approach.
A longer-acting formulation of Otsuka Pharmaceuticals’ aripiprazole could help soften the blow of Abilify Maintena’s loss of exclusivity coming later this year, according to a new report from GlobalData.