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Accelerated EU Committee Nod for J&J/Genmab's Darzalex

 
• By Alexandra Shimmings

Janssen-Cilag (Johnson & Johnson) and Genmab's CD38 monoclonal antibody product Darzalex (daratumumab) has been granted the green light for approval in adults with relapsed and refractory multiple myeloma, under an accelerated procedure.

Janssen-Cilag (Johnson & Johnson) and Genmab's CD38 monoclonal antibody product Darzalex (daratumumab) has been granted the green light for approval in adults with relapsed and refractory multiple myeloma, under an accelerated procedure.

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More from Cardiovascular

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.

US FDA Expands Label For BMS’s Camzyos Days After Phase III Stumble

 
• By Alaric DeArment

The agency loosened requirements for echocardiograms and removed contraindications for a number of commonly used drugs.

Camzyos nHCM Failure Could Open Door To Threat From Cytokinetics’ Aficamten

 
• By Alaric DeArment

BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.

More from Therapy Areas

Zai’s R&D Head Touts ‘Beauty’ Of Novel Internal Assets

 
• By Dexter Jie Yan

Two potentially first-in-class molecules signify Zai Lab’s renewed drive for the in-house discovery of drugs that it requires “to be innovative, differentiated and to have the potential to make a big difference for patients,” its global R&D head tells Scrip.

J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 
• By Jessica Merrill

The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

GSK Chief Optimistic About BD Despite Volatile Environment

 
• By Kevin Grogan

Emma Walmsley tells Scrip that the "biotech market is under a certain degree of pressure," so reasonably priced deals are available.