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Teva and Allergan finalise terms of US opioid settlements worth $6.6bn combined

Nearly 500,000 died from an opioid overdose between 1999 and 2019

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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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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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AstraZeneca receives CHMP recommendations for Imfinzi, Enhertu and Lynparza

The treatments are for use in prostate, biliary tract and advanced gastric cancer

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Sanofi/Regeneron’s Dupixent receives CHMP recommendation for prurigo nodularis

Two phase 3 trials showed a reduction in itch, skin lesions and health-related quality of life

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Pfizer/BioNTech BA.4/BA.5 COVID-19 booster receives CHMP recommendation for children five to 11 years

If an authorisation is granted, doses of the bivalent booster will be available to all 27 EU member states

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AZ and Avillion’s asthma rescue treatment recommended by FDA Advisory Committee

PT027 significantly reduced the risk of severe asthma exacerbations

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Regeneron’s Libtayo combination granted FDA approval for non-small-cell lung cancer

The decision was based on superior survival outcomes of Libtayo plus chemotherapy

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Pfizer’s multiple myeloma treatment granted FDA Breakthrough Therapy Designation

Elranatamab-treated patients achieved an overall response rate of 61% in a phase 2 trial

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Gilead’s Vemlidy gets FDA approval for paediatric patients with chronic hepatitis B infection

The application was supported by positive 24-week data from a phase 2 trial

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