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‘Disappointed’ UCB And Amgen Will Appeal CHMP’s Negative Evenity Decision

 
• By Sten Stovall

The EMA’s CHMP cited concerns over cardiovascular side effects as the reason why it took a negative stance on Evenity’s use in the EU for treating severe osteoporosis.

Osteoporosis
CHMP rejection contrasts with FDA's approval of Evenity in April • Source: Shutterstock

UCB Group and Amgen Inc. said they were “disappointed” by the negative opinion given their osteoporosis drug Evenity (romosozumab) on 27 June by the European Medicines Agency's drug evaluation committee, CHMP, and promised to appeal the decision which, if left unchanged, would block the investigational medicine’s prospects to treat severe osteoporosis in Europe.

The European Medicines Agency said it and the CHMP were “concerned” because the results submitted by UCB “suggested that patients given Evenity had an increased risk of serious effects on the

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Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Shionogi In $1bn Deal For Japan Tobacco’s Pharma Ops

 
• By Ian Haydock

Mid-sized Japanese pharma firm to acquire tobacco giant’s pharma operations and take private the listed Torii Pharmaceutical business, in bid to build sales reach and strengthen manufacturing.

Sarepta Slammed By Double Blow: Elevidys Sales Miss, Prasad’s CBER Appointment

 
• By Mandy Jackson

Sarepta’s stock price was battered after Vinay Prasad was appointed to lead the US FDA’s CBER, then the company’s shares were bruised when Q1 Elevidys sales came in below consensus.

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

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BeiGene To Trade Beach For Chalet In Swiss Redomiciling As BeOne

 
• By Alaric DeArment

The biotech saw a slight quarter-over-quarter decline in sales from the BTK inhibitor Brukinsa, which it attributed to seasonality, while revenues overall missed some analyst estimates.

Industry Makes Its Case To Trump In Effort To Sidestep Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a 232 investigation.

Copycats Compound Novo’s Wegovy Growth Problems

 
• By Andrew McConaghie

The US FDA has ordered compounders of the Danish firm's obesity drug semaglutide to shut up shop later this month, but competition from Eli Lilly is only increasing.