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Adult holding the hand of a newborn baby

MSD eyes June verdict for paediatric RSV antibody

The FDA has started a review of MSD's RSV antibody clesrovimab, a potential rival to Beyfortus, with a verdict due in the middle of next year.

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FDA dents J&J's blockbuster hopes for Rybrevant

FDA has sent a complete response letter to J&J, denying approval of its subcutaneous version of lung cancer therapy Rybrevant.

News

Refiling for cALD therapy on the cards after new data

Readout from NEXUS study sets up mid-2025 refiling for Minoryx and Neuraxpharm's leriglitazone for rare disease cerebral adrenoleukodystrophy (cALD).

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uniQure rockets on map to market for Huntington's therapy

uniQure says it has reached agreement with the FDA on a pathway to accelerated approval for its much-anticipated Huntington's disease gene therapy.

News

Novo’s $16.5bn Catalent deal cleared by EU Commission

EU says Novo Holdings’ $16.5 billion takeover of US contract development and manufacturing organisation Catalent does not pose antitrust issues.

News

MHRA's stature undermined by lack of resources says pharma

The MHRA isn't sufficiently funded to meet its obligations and that could threaten UK investment in life sciences, according to an ABPI report.

MSD eyes June verdict for paediatric RSV antibody

FDA dents J&J's blockbuster hopes for Rybrevant

Refiling for cALD therapy on the cards after new data

uniQure rockets on map to market for Huntington's therapy

Novo’s $16.5bn Catalent deal cleared by EU Commission

MHRA's stature undermined by lack of resources says pharma

World Without Disease initiative: 2024 update

The AI effect in pharma commercial strategy: From data to re...

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