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Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
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.
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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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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Venture Capital firms Atlas Venture, Bain Capital Life Sciences and RTW Investments have led a $400 million Series A for Kailera Therapeutics, the latest obesity biotech to hit the scene.
A week after it released positive early-stage data, Metsera has partnered with Amneal Pharmaceuticals in an effort to secure the development and supply of its investigational weight loss therapy MET-097.
In an effort to expand its cash runway beyond 12 months, Prime Medicine has signed a deal with Bristol Myers Squibb worth a potential $3.5 billion, while also streamlining its pipeline to trim costs.
The acquisition was featured Monday in Roche’s Pharma Day presentation, which also included projections of more than $3 billion in annual sales from three early-stage obesity and diabetes drugs.
Six months after treatment with the radiopharmaceutical therapy, 77.8% of patients with meningioma were alive and had not experienced further disease progression, beating the 26% benchmark established in earlier studies.
Johnson & Johnson linked Carvykti to a 45% reduction in risk of death and Darzalex to a 61% improvement in minimal residual disease-negativity, boosting the prospects of two key growth drivers for the company.
After the FDA declined to approve Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder, companies are pivoting away from or delaying similar therapeutics targeting the psychiatric disease.
Women are already underrepresented in clinical trials; the new abortion and IVF laws could make it worse.
One upcoming decision—on a perioperative PD-1 regimen for lung cancer—comes as the FDA considers an overhaul of trial designs in this treatment setting.