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Micro Labs

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Biogen and Eisai announce FDA submission for early Alzheimer’s treatment

The licence application for the treatment of mild cognitive impairment due to Alzheimer’s disease was made as part of the accelerated approval pathway programme

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AstraZeneca’s Imfinzi plus chemotherapy accepted for Priority Review in the US

The drug combination offers biliary tract cancer patients a new treatment option

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FDA limits use of Janssen’s COVID-19 vaccine

Authorisation of Janssen COVID-19 vaccine restricted among certain people following analysis and evaluation

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FDA grants Prothena fast-track designation for next-generation Alzheimer’s disease therapy

Approximately 50 million people worldwide are estimated to be living with Alzheimer’s disease or other dementias

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FDA approves Alexion’s Ultomiris for generalised myasthenia gravis

gMG is a rare autoimmune neuromuscular disease that causes a loss of muscle function and severe weakness

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Pfizer and Valneva announce positive phase 2 paediatric data for lyme disease vaccine

VLA15 is currently the only Lyme disease vaccine candidate in clinical development

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FDA approves COVID-19 treatment for those under the age of 12

Veklury is currently the only COVID-19 treatment approved for this age group

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Kite’s new CAR T-cell therapy manufacturing facility given the go-ahead by the FDA

The site in the US will produce CAR T-cell therapies for patients with blood cancers

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NHS to offer two new treatments for drug-resistant superbugs as part of a new subscription-style payment plan

Manufacturers will receive a fixed yearly fee of £10m, instead of receiving individual payments per dose

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Enhertu to provide patients with vital targeted therapy option

Therapy receives FDA priority review as patients with HER2-mutant metastatic non-small cell lung cancer seek alternative treatment

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BMS Foundation announces Robert A Winn Diversity in Clinical Trials Award Program

The $100m initiative was started in 2020 to increase diversity in clinical trials

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Pfizer appoints David Denton as chief financial officer and executive vice president

Denton’s appointment follows the departure of Frank D’Amelio, the current CFO and executive vice president

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