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Q3 results

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Pfizer/BioNTech submit FDA application for BA.4/BA.5 COVID-19 vaccine in children under five

The vaccine is already authorised as a booster for ages five years and older in the US and EU

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Kinarus’ KIN001 shows strong antiviral activity against BA.2 and BA.5 Omicron subvariants

The phase 2 trial of KIN001 in ambulatory COVID-19 patients is actively recruiting

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FDA approves Rigel’s Rezlidhia for acute myeloid leukaemia

Phase 2 data showed a complete remission rate of 35% and median duration of 25.9 months

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FDA approves Scynexis’ Brexafemme for recurrent vulvovaginal candidiasis

The antifungal is already approved in the US for vulvovaginal candidiasis

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Lilly’s donanemab shows promise in early symptomatic Alzheimer’s comparator study

Brain amyloid clearance was achieved in 37.9% of patients treated with the investigational antibody

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bluebird bio sells Rare Pediatric Disease Priority Review Voucher

The company was granted two PRVs upon the FDA approvals of Zynteglo and Skysona

Can Cinderella save us?

UK government launches consultation on silent AMR pandemic

The consultation will call upon the latest data from experts on antimicrobial resistance

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FDA approves first gene therapy for adults with haemophilia B

CSL’s Hemgenix allowed patients to produce mean factor IX activity of 39% at six months

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Roche’s high-throughput monkeypox test approved for emergency use by FDA

The tests will be conducted on the company’s 6800/8800 cobas systems

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FDA advisory committee recommends Ardelyx’s Xphozah for chronic kidney disease

The phase 3 trials supporting the submission met all primary and key secondary endpoints

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Moderna’s bivalent Omicron-targeting boosters show superiority to original COVID-19 vaccine

Both boosters produced a better immune response against Omicron BA.4/BA.5 subvariants

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FDA approves ImmunoGen’s Elahere for platinum-resistant ovarian cancer

An overall response rate of 31.7% was demonstrated, including five complete responses

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