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naltrexone

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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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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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Pfizer and viral infection specialist ReViral agree on $525m deal

According to the deal, Pfizer will acquire ReViral for a total of up to $525m

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FDA delays Merck’s pneumococcal vaccine Vaxneuvance

It is predicted that the vaccine could make over $1bn in peak sales

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FDA grants Pfizer/BioNTech expanded EUA for an additional COVID-19 vaccine booster

The second booster authorisation is for those aged 50 years and older to promote high levels of protection against COVID-19 in the most vulnerable groups

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