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Bayer's Xarelto 'Safe' Despite ROCKET Device Defect

 
• By Alexandra Shimmings

A defective INR device used to monitor blood clotting in the main study supporting the 2011 approval of Bayer AG's new oral anticoagulant Xarelto (rivaroxaban) in stroke prevention in atrial fibrillation had no effect on the safety and benefit/risk balance of the product, the EMA has concluded. Xarelto can continue to be used as before, in line with the current prescribing information, it said.

A defective INR device used to monitor blood clotting in the main study supporting the 2011 approval of Bayer AG's new oral anticoagulant Xarelto (rivaroxaban) in stroke prevention in atrial fibrillation had no effect on the safety and benefit/risk balance of the product, the EMA has concluded. Xarelto can continue to be used as before, in line with the current prescribing information, it said.

The conclusions provide reassurance for the top-selling product ahead of Bayer's full year results presentation on Feb. 25

More from Cardiovascular

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

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.

Merck & Co. CMO Eliav Barr Assures On Pipeline As Keytruda LOE Looms Large

 
• By Jessica Merrill

Chief medical officer Eliav Barr, responsible for overseeing clinical development, talked to Scrip in an interview at Merck’s headquarters about the company’s pipeline diversification.

CNS, Cardiometabolics A Bright Spot In Recent Chinese VC/PE Fundings

 
• By Dexter Jie Yan

Over the past few months, Chinese developers of CNS and cardiometabolic therapies have attracted the interest of domestic investors, amid generally modest funding activity.

More from Therapy Areas

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.

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.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.