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Chantix

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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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The key to psoriasis innovation? Dispelling the shadow of the JAK inhibitor

Powerful therapies that can improve skin clarity dominate the psoriasis landscape, so why are most patients stuck in a cycle of ineffective topicals? Fishawack Health explores the market and reveals how life...

Avalere Health

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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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Pfizer, BioNTech eye US approval for COVID-19 booster dose

Companies plan to request an emergency use authorisation from the FDA for the booster dose in August

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AbbVie, Biogen and Pfizer collaboration creates new resource for genetic exome sequence analysis

Companies have created 'world’s largest' resource for genetic exome sequence analysis

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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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Israel study suggests Pfizer/BioNTech vaccine is less effective against Delta variant

Data suggests vaccine is 64% effective at preventing infection caused by Delta variant after two doses

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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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Pfizer/BioNTech, AZ vaccines effective against Delta COVID-19 variant after two doses

Pfizer/BioNTech and AZ vaccines found to be 96% and 92% effective against variant, respectively

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