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US warns Bayer API facility in Germany over GMP violations

 
• By Sue Sutter

A US FDA warning letter citing good manufacturing practice violations at a Bayer Schering Pharma facility focuses largely on the firm's practice of averaging analytical sample results that failed specifications.

A US FDA warning letter citing good manufacturing practice violations at a Bayer Schering Pharma facility focuses largely on the firm's practice of averaging analytical sample results that failed specifications.

The letter stems from a March inspection of a non-sterile active pharmaceutical ingredient manufacturing facility in Bergkamen, Germany. The inspection...

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

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.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

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

 
• By Andrew McConaghie

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

 
• By Andrew McConaghie

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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Supernus Secures Sage With CVR-Supported Deal

 
• By Jessica Merrill

Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.

BMS’s Breyanzi Stands To Further Expand Broad Lymphoma Coverage

 
• By Alaric DeArment

The drugmaker presented data at a lymphoma meeting showing strong efficacy for the CAR-T in marginal zone lymphoma, the second most common indolent lymphoma.

Early Blood Cancer Data Impresses As Incyte Plots Post-Jakafi Strategy

 
• By Kevin Grogan

First results for a first-in-class mutCALR-targeted therapy in essential thrombocythemia presented at EHA point to a lucrative future for the early-stage product.