Rgenta Therapeutics Inc. has received IND clearance by the FDA for RGT-61159, which is being developed for adenoid cystic carcinoma, colorectal cancer and other solid tumors, as well as acute myeloid leukemia.
Having secured a 40% price cut and a commitment to not enforce a patent protecting a tuberculosis drug, South Africa’s Competition Commission decided not to prosecute a complaint accusing Johnson & Johnson (J&J) and its subsidiary, Janssen Pharmaceutica (Pty) Ltd., of anticompetitive conduct.
In the recently cast shadow of the U.S. Supreme Court’s Loper Bright decision that unraveled Chevron deference for federal agencies, the FTC’s broad rule banning noncompete employment clauses is on shaky ground. The first tremor hit July 3 when the U.S. District Court for the Northern District of Texas temporarily enjoined the FTC Noncompete Rule that is scheduled to go into effect Sept. 4 on the grounds that the agency overstepped its authority.
The draft version of the U.S. Medicare hospital outpatient rule for 2025 carries more than a dozen applications for a new technology pass-through payment next year, but Boston Scientific Corp.’s Agent balloon for treatment of in-stent restenosis might not be eligible for NTPT payment because of a debate over whether the device can be assigned to an existing Healthcare Common Procedure Coding System code.
Roche Holdings AG received CE mark for its artificial intelligence (AI)-enabled continuous glucose monitoring (CGM) system, Accu-Chek Smartguide. The company said the solution addresses the unmet need around diabetes management and glycemic control as it offers critical predictions to people living with type 1 and type 2 diabetes.
Setpoint Medical Corp. reported positive topline results from its landmark RESET-RA study. The study evaluated the Setpoint system as a potential new neuroimmune modulation treatment for adults living with moderate-to-severe rheumatoid arthritis who are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs.
In an action two years in the making, Dublin-based Medtronic plc withdrew a series of endotracheal tubes because of complaints of lost functionality that carries the risk of respiratory and/or cardiac arrest.
Abata Therapeutics Inc. has obtained FDA clearance for its IND application enabling initiation of a first-in-human study of ABA-101 in patients with progressive multiple sclerosis (MS). A phase I study will open later this year.
Just because a statement turns out to be false doesn’t mean it was intended to be, the U.S. Court of Appeals for the First Circuit said in tossing a stockholder class action against Frequency Therapeutics Inc., now part of Korro Bio Inc.
The redacted interim report released July 9 of an ongoing FTC investigation into pharmacy benefit managers (PBMs) shed little, if any, new insight into PBM practices and how they impact availability and pricing of prescription drugs in the U.S.
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