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FDA opens door to COVID-19 booster jabs

FDA approves third shot of mRNA vaccine for the immunocompromised but EMA says there’s “not yet enough data”

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FDA grants orphan drug status to Allogene’s BCMA-targeted treatment for multiple myeloma

The decision follows the RMAT designation granted by the FDA in April

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FDA requests further safety trials for AZ, FibroGen’s roxadustat

The response follows concerns over serious thrombotic events and seizures

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Gene therapy company bluebird bio quits Europe

The decision comes after a trial in a rare neurological disease is halted over safety concerns and the FDA has placed the eli-cel programme on clinical hold

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Roche engaged in talks with FDA for Alzheimer’s drug candidate

CEO Severin Schwan told reporters Roche will complete a phase 3 trial of gantenerumab in the second half of 2022

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Merck, Eisai’s Keytruda/Lenvima regimen scores full approval in endometrial cancer

Keytruda plus Lenvima was previously approved under the FDA’s accelerated approval process

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Bayer’s BlueRock Therapeutics gains FDA fast track for Parkinson’s disease cell therapy

In 2019, Bayer bought out its private equity partner Versant Ventures and founders in BlueRock Therapeutics for $240m

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Keytruda scores a win in treating early-stage breast cancer pre- and post-surgery

The FDA had previously rejected a supplemental biologics licence application in this indication

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FDA advisory committee votes against approval of AZ, FibroGen’s roxadustat

Briefing documents published earlier this week raised questions over the safety profile of roxadustat

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FDA rejects Provention Bio’s type 1 diabetes prevention drug

FDA said a study of healthy volunteers failed to demonstrate that the planned commercial product is comparable to an older version used in previous clinical trials

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Breakthrough therapy designated for Lilly’s investigational Alzheimer’s drug donanemab

The BTD is based on data from the phase 2 TRAILBLAZER-ALZ study in early symptomatic Alzheimer's patients

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Biogen plans confirmatory trial as FDA documents show struggle over Aduhelm approval

Confirmatory trial is planned to be completed ahead of nine-year time frame

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