Following the U.S. FDA’s expansion of competing BCMA-targeting CAR T therapy Abecma (idecabtagene vicleucel) to include third-line and later treatment in multiple myeloma (MM) patients, the agency cleared Carvykti (ciltacabtagene autoleucel) from Legend Biotech Corp. and Johnson & Johnson’s Janssen unit for use in MM patients as early as second-line treatment. The label, which RBC Capital Markets analyst Leonid Timashev called a “best-case scenario,” includes no notable updates to the black box warning and should help accelerate and expand Carvykti’s update in the U.S., with 2024 revenues expected to top $950 million.
Med-tech powerhouse Johnson & Johnson made a bold bid to bolster its interventional cardiology holdings with the news on April 5 that it is acquiring Shockwave Medical Inc. for approximately $13.1 billion including cash acquired. The $335 per share cash price represents a more than 5% premium to Shockwave’s (Nasdaq: SWAV) April 4 closing price.
Yes, even a phase III protocol for a “failed” trial can constitute prior art, the U.S. Court of Appeals for the Federal Circuit told a lower court April 1 when it returned Janssen Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc.’s patent squabble for a do-over.
An increasingly popular target across varied cancer types is the immune system regulator V-domain Ig suppressor of T-cell activation (VISTA), where a number of developers have taken early stage aim – among them Sensei Biotherapeutics Inc., with SNS-101, which Wainwright analyst Edward White believes could be the first anti-VISTA monoclonal antibody approved as a therapeutic agent. But there’s plenty of work ahead.
While some states are beginning to double down on the prices they pay for prescription drugs, the state of Colorado is taking it to a whole new level with its Prescription Drug Affordability Review Board that was empowered to set maximum prices of prescription drugs it considers “unaffordable.”
The U.S. FDA’s Oncology Drugs Advisory Committee, in two separate sessions, took up the matters of Carvykti (ciltacabtagene autoleucel) from Johnson & Johnson and the Bristol Myers Squibb Co. product Abecma (idecabtagene vicleucel) – specifically, whether the benefits of each CAR T therapy outweigh the risks in relapsed or refractory multiple myeloma (MM).
There’s no denying that Johnson & Johnson’s Carvykti (ciltacabtagene autoleucel) and Bristol Myers Squibb Co.’s Abecma (idecabtagene vicleucel) show clinical benefit as they seek to move up in the line of treatment for relapsed or refractory multiple myeloma. But the question that will be put to the U.S. FDA’s Oncology Drugs Advisory Committee March 15 is whether the benefit outweighs a risk of early deaths seen with both CAR T therapies.
With two U.S. courts rejecting constitutional challenges to Medicare drug price negotiations, every company that had a drug selected for the first round of negotiations countered Medicare’s initial offer of what it considered a maximum fair price by the March 2 deadline, according to the Biden administration.
Continuing the spate of regulatory approvals for pulsed field ablation (PFA) devices around the world, Johnson & Johnson’s Biosense Webster Inc. unit secured CE mark for the Varipulse platform for treatment of symptomatic, drug-refractory recurrent paroxysmal atrial fibrillation.
The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics.
