The U.S. FDA sent out a friendly reminder to more than 2,200 sponsors and researchers, associated with more than 3,000 clinical trials, who may be delinquent in disclosing the results of those studies on clinicaltrials.gov.

Avanos Medical Inc. has agreed to be acquired by affiliates of American Industrial Partners (AIP)  in an all-cash deal valuing the company at approximately $1.272 billion. Under the terms of the definitive agreement, Avanos stockholders will receive $25 per share in cash for each share of common stock they hold.

Abbvie Inc. is buying exclusive rights to develop, manufacture and commercialize two Nav1.8 inhibitors for pain – HSK-55718 and HSK-51155 – from Haisco Pharmaceutical Group Co. Ltd. for $30 million up front and up to $715 million in milestone payments, plus royalties.

Tr1x Inc. was founded with a simple but ambitious goal: to change how autoimmune and inflammatory diseases are treated, moving away from chronic treatment and toward durable cures. “We are trying to flip the script on regulatory T cells (Tregs),” Tr1x CEO David de Vries told BioWorld. “The goal is to reset the immune system rather than continuously suppress it, and we believe we have a unique technology to do that.”

Cortec GmbH is preparing to implant its brain-computer interface (BCI) technology into a third stroke patient, with early clinical data showing that the device leads to significant improvement in hand and arm function. The company believes its Brain Interchange system could transform the lives of millions of patients.

Amazon is extending the reach of its “everything store” into drug R&D with the launch of an artificial intelligence-powered Bio Discovery business. The company has compiled a catalogue of 40-plus foundation models that have been trained on extensive biology datasets and are able to generate and evaluate drug molecules in silico. For now, this covers antibodies only, but it is intended to move into other modalities.

Researchers at the University of Edinburgh are pioneering a cancer therapy that destroys tumors from within while reawakening the immune system, using synthetic super-enhancers (SSEs) to drive targeted killing and durable protection against recurrence. The work builds on a decade of research focused on how glioblastoma stem cells (GSCs) sustain their aggressive cancer identity.

Becoming the first and only fully FDA-approved treatment for focal segmental glomerulosclerosis (FSGS), Travere Therapeutics Inc.’s Filspari (sparsentan) has gained access to a second lucrative market with a regulatory package that validates proteinuria as a surrogate endpoint.

In a move that could give patients quick access to drugs their doctors prescribe, the U.S. CMS is proposing a rule giving insurers no more than 24 hours to respond to urgent prior authorization requests and 72 hours for standard requests. The rule also would require full disclosure of claims denials and appeals outcomes.