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"Shock waves" from GSK's $750M settlement on alleged cGMP failures, lawyers say

 
• By Nancy Faigen

GlaxoSmithKline's recent agreement to pay $750 million to resolve civil and criminal liability in connection with alleged cGMP failures at its now-shuttered facility in Cidra, Puerto Rico, is outside the norm and some believe opens up a new frontier for US whistleblower suits.

GlaxoSmithKline's recent agreement to pay $750 million to resolve civil and criminal liability in connection with alleged cGMP failures at its now-shuttered facility in Cidra, Puerto Rico, is outside the norm and some believe opens up a new frontier for US whistleblower suits.

It is undoubtedly sending "shock waves" throughout the industry and means that any FDA-regulated firm "must pay close attention to...

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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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Lilly CEO Ricks Advocates Rebalancing Drug Pricing Between US And Europe

 
• By Mandy Jackson

As President Trump focuses on “most favored nation” pricing to bring down US drug costs, CEO David Ricks used Lilly’s Q2 earnings call to advocate for a slow approach to reducing the difference between US and EU drug prices.

Genmab/AbbVie’s Epkinly Likely To See Label Expansion After Phase III Win

 
• By Alaric DeArment

The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.

Sanofi’s Sarclisa Wins Another EU Multiple Myeloma Nod In Its Unequal Battle With J&J’s Darzalex

 
• By Sushmita Panda

The French drugmaker's anti-CD38 antibody has racked up another approval in first-line multiple myeloma, but it marks a small victory while the company develops a subcutaneous version to help level the field with J&J’s Darzalex.