regulatory

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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.

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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.

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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.

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Warning letter adds to Applied Tx run of bad news

Applied Therapeutics gets a warning letter from the FDA over a trial of rare disease drug govorestat, which was rejected by the agency last week.

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Cytokinetics' president and chief executive Robert Blum

FDA kicks off review of Cytokinetics' aficamten for HCM

Cytokinetics should hear back from the FDA next September about its application for Camzyos rival aficamten in obstructive hypertrophic cardiomyopathy

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

Warning letter adds to Applied Tx run of bad news

FDA kicks off review of Cytokinetics' aficamten for HCM

Ambrosia's sweet $100m round, and other biofinancings

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