The FDA will convene an advisory committee to discuss Johnson & Johnson and Legend's Carvykti filing in earlier multiple myeloma. AstraZeneca has won a world-first approval for its rare blood disorder add-on therapy in Japan. Samsung Biologics tallied an “exceptional” year in 2023. And more.
1. J&J, Legend's Carvykti bid for earlier multiple myeloma use will face FDA adcomm
Johnson & Johnson and Legend Biotech’s application for Carvykti for earlier treatment of multiple myeloma will have to endure an FDA advisory committee meeting. Bristol Myers Squibb previously announced that the company’s rival CAR-T therapy, Abecma, will also face such a meeting. The FDA reviews come as the agency pushes for a new boxed warning outlining the risk of patients developing secondary T-cell cancers following the treatment of existing CAR-T therapies.
2. AstraZeneca adds to rare blood disease portfolio with world-first Voydeya approval in Japan
AstraZeneca’s oral factor D inhibitor, danicopan, has won its world-first approval in Japan. Now branded as Voydeya, the drug is approved by Japanese authorities for use alongside a C5 inhibitor such as AZ’s Ultomiris to treat paroxysmal nocturnal hemoglobinuria patients who’ve had an inadequate response to a C5 inhibitor.
3. With record year, Samsung Biologics bucks CDMO industry's troublesome 2023
Samsung Biologics touted what it called an “exceptional” performance in 2023 despite an industrywide slowdown. In the fourth quarter, the Korean CDMO grew sales by 11% to 1.07 trillion Korean won ($802 million), pushing the full-year growth rate to 23.1%. Further, the company amassed contracts worth over $12 billion through expanded partnerships with 14 of the top 20 global pharma companies.
Meanwhile, Samsung Electronics is working on noninvasive blood sugar monitoring for its Galaxy family of consumer devices, Hon Pak, M.D., head of the company’s digital health division, said. Samsung’s rival, Apple, is also trying to achieve a breakthrough in the same field. Pak also talked about the possibility of adding continuous cuffless blood pressure monitoring to Samsung’s wearables.
5. Glenmark bags subcutaneous checkpoint inhibitor, moving to turf targeted by Big Pharma
Glenmark has picked up some regional rights to 3D Medicines and Jiangsu Alphamab Biopharmacueticals’ subcutaneous anti-PD-L1 antibody envafolimab. With a Chinese nod in 2021, the drug became the first subcutaneous checkpoint inhibitor approved anywhere. Glenmark is paying “low double-digit millions” for rights to sell the drug in India, Asia Pacific, the Middle East, Latin America, Africa, Russia and other places.
6. Gene therapy with dual viral vector restores hearing in children with hereditary deafness (release)
A new study in China showed that a gene therapy restored hearing in five of six children with a form of deafness caused by mutations of the OTOF gene. The children showed a 40 to 57 decibel reduction in the auditory brainstem response testing after 26 weeks, according to results published in The Lancet. The therapy belongs to Refreshgene Therapeutics in Shanghai, and it utilizes a dual-AAV viral vector to deliver a functional OTOF gene.
Other News of Note:
7. WuXi XDC, hot off $520M IPO, inks antibody-drug conjugate deal with Celltrion
8. Saudi Arabia launches plan to become biotech hub by 2040
9. Apotex, Heritage and Breckenridge settle with purchasers in generics price-fixing case