The FDA has given expanded labeling to Nevro's Senza spinal cord stimulation system, allowing it to be used to treat non-surgical refractory back pain. "Nevro is now the only SCS company with specific, on-label indications for treating both NSRBP and painful diabetic neuropathy patients," said President and CEO Keith Grossman.
The FDA has given 510(k) clearance to Claritas HealthTech for its Claritas iPET image processing software. The software sharpens organ boundaries to improve the quality of PET scans.
Robert Califf, President Joe Biden's nominee for FDA commissioner, agreed with other industry experts that confirmatory trial completion is key to the success of the FDA's accelerated approval program, and he said new legislation may be necessary to stimulate generation of confirmatory data. Speaking at a recent summit, Califf praised the program's design but said its biggest problem is "the failure to produce confirmatory evidence quickly and in a way that really gives us the information that we need as patients and clinicians to decide which treatments are most effective and in which order."
The FDA has presented three case studies that serve as examples of innovative clinical study designs that can be accepted in the agency's Complex Innovative Trial Designs pilot meeting program. The goal is to help drug developers understand the factors that need to be considered when making a CID proposal.
Mylan Pharmaceuticals is recalling one batch of its Semglee prefilled insulin injection pens due to missing labels. The affected products carry the batch number BF20003118 and have an August 2022 expiration date.
On Thursday, the Medicines Patent Pool backed by the UN announced that Merck will allow production of COVID-19 pill molnupiravir, co-developed with Ridgeback Therapeutics, by 27 generic-drug makers so that the drug can be more widely available in 105 developing countries. The agreements with the companies stipulate that they may produce both the drug's raw ingredients and the final product.
GlaxoSmithKline extended a drug discovery collaboration with 23andMe to July 2023, which 23andMe CEO Anne Wojcicki says has been "an absolute amazing journey." The companies have the option to split costs and profits on joint programs, but 23andMe chose to earn royalties on future sales of a cancer drug that is in Phase 1 testing so that capital can be used for "more things that are at earlier stages," says 23andMe CFO Steve Schoch.