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FDA's CMC Guidance For Investigational Gene Therapies Reflects Broader CMC Evolution

 
• By Bowman Cox

New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference.

Gene editiing

When US FDA published a suite of gene therapy guidance documents on July 11 just moments before she took the podium at a cell and gene therapy conference in North Bethesda, Maryland, Denise Gavin of the agency's Center for Biologics Evaluation and Research changed her presentation to discuss the documents.

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Pharma Still Nervous While Riding Trump’s Tariff Rollercoaster

 
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The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.

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• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

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More from Compliance

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• By Andrew McConaghie

Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.

Trump’s Tariffs Will Lead To ‘Instability’ And ‘Less Investment’ In UK

 
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While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
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Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?