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Quell takes new Treg into clinic after transplant study halt

Quell Therapeutics changes tack, starting trials of a CAR-Treg in rheumatoid arthritis and systemic sclerosis and parking its transplant therapy.

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United's PAH drug clears phase 3 trial, setting up filings

United Therapeutics will file ralinepag as a treatment for pulmonary arterial hypertension later this year, but can it compete in a crowded market?

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New FDA knockback hits uniQure and Huntington patients hard

uniQure looks like it may have to run another trial of its Huntington's disease gene therapy AMT-130, delaying the highly anticipated programme.

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After phase 3 clean sweep, Roche plans oral BTK filing in MS

Roche is preparing to file for its oral multiple sclerosis drug fenebrutinib after a third phase 3 win, but could liver toxicity be a stumbling block?

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New biotech Atrium born out of Novartis/Avidity marriage

Atrium Therapeutics has launched with $270m in funding and two preclinical siRNA candidates for rare genetic cardiomyopathies.

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US lawmakers take FDA to task over rare diseases record

Lawmakers and patient advocates in the US are concerned that the FDA's regulation of rare disease therapies has been inconsistent and overly cautious.

Quell takes new Treg into clinic after transplant study halt

United's PAH drug clears phase 3 trial, setting up filings

New FDA knockback hits uniQure and Huntington patients hard

After phase 3 clean sweep, Roche plans oral BTK filing in MS

New biotech Atrium born out of Novartis/Avidity marriage

US lawmakers take FDA to task over rare diseases record

AI in clinical development & ‘white space’, with Andrew McKi...

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