USP Tightens Supply Chain Controls with Risk-Based Vendor Qualification; Aims To Prevent New Heparin Crisis

The U.S. Pharmacopeia is taking a forward-looking, risk-based approach to protecting the supply chain for biological drug products from intentional and unintentional adulteration, even as it adds testing requirements aimed at preventing a new heparin crisis

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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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Phase III Success For AstraZeneca’s $5bn Hypertension Hope Baxdrostat

 

Rivals Mineralys could be first to file but AstraZeneca is banking on its cardiovascular market know-how to lead the emerging class.

Leo Lands Another Big Pharma Pact With Boehringer Spevigo Deal

 
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Paying €90m upfront for rights to generalized pustular psoriasis drug.

Pipeline Watch: Ten Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.