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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.

The decision comes two months after Bristol-Myers Squibb's rival multiple myeloma product Empliciti (elotuzumab) received its own accelerated decision...

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More from Cardiovascular

Ionis’s Olezarsen Data Meet Multiple Marks In Blockbuster sHTG Indication

 
• By Mandy Jackson

Phase III CORE and CORE2 results presented at the AHA meeting in severe hypertriglyceridemia showed durable triglyceride lowering and reductions in acute pancreatitis across patient subgroups, supporting expansion of Tryngolza (olezarsen) into a second, larger indication.

Amgen’s ‘Stunning’ VESALIUS Results Could Push Repatha Into The Mainstream

 
• By Mandy Jackson

Cardiologists know PCSK9 inhibition is a powerful LDL-lowering tool and now Amgen’s VESALIUS data show it may be worth adding to the primary care physician’s toolbox for prevention of high-risk patients’ first major cardiovascular events.

Intellia Hits Pause On Phase III Nex-z Studies After Second Liver Enzyme Event

 
• By Alaric DeArment

The company reported that a patient went to the emergency room after experiencing grade 4 transaminase elevations, which unlike a similar event in May caused symptoms.

Ionis Poised To Break Even In 2028 Fueled By A Cadence Of Launches

 
• By Jessica Merrill

Ionis showcased its first two wholly owned launches and plans for two more independent launches in 2026 during a recent pipeline and portfolio review.

More from Therapy Areas

Lilly’s Eloralintide Success Sets Bar For Amylin Rivals

 
• By Andrew McConaghie

The US pharma giant may have a best-in-class amylin agonist to go with incretin blockbuster Zepbound, but challengers could still go one better on safety and tolerability.

Lilly, Novo Lower US Obesity Drug Prices To Secure Government Coverage

 
• By Jessica Merrill

Wegovy and Zepbound will cost around $250 per month under Medicare and Medicaid, and the drugs will cost around $350 per month through TrumpRx.

Lilly Plans Phase III Trials After Positive Results From Amylin Drug Eloralintide

 
• By Alaric DeArment

The drugmaker presented positive data from its Phase II study at ObesityWeek that help validate the amylin class overall, which includes more than a dozen entrants.