China's Pro-science Leaders To Make Biotech Drugs A Central Plank In New Five Year Plan

 

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Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

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Galapagos Expands Point-Of-Care CAR-T Study To The US

 

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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Takeda Plans US Investment But Sees Little Impact From Tariffs

 

The Japanese drug maker is on track for three pivotal Phase III readouts and two regulatory submissions in 2025.

Q1 S&E In Brief: Tracking New Launches And Catalysts In Biopharma

 

Neurocrine, Madrigal and Vanda updated investors on new drug launches, while Cytokinetics talked to investors about an FDA extension for aficamten.

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.