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. Read More
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. Read More
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. Read More
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.” Read More
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. Read More
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. Read More
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. Read More
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. Read More
If a recent warning letter is anything to go by, the U.S. FDA could be using the 2013 Drug Supply Chain Security Act as another enforcement tool to shut down unauthorized suppliers by clamping down on the dispensers that purchase their unapproved drug products. Read More
The U.S. FDA’s latest draft guidance on gene therapies focuses on nonclinical studies using next-generation sequencing-based methods and bioinformatics to evaluate safety risks associated with off-target editing and loss of genome integrity in human gene-edited products. Read More
New hires and promotions in the biopharma and med-tech industries, including: Alx Oncology, Dariohealth, Epitopea, Frontier, Geron, Leal, Lineage, Nrx, OS, Palvella, Pelthos, Prothena. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Hemab, Imagenebio, Lobe, Neomorph, Quiver, Seaport, Sharp. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Abbvie, Allogene, Biontech, Caliway, Caliway, Corcept, Duality, Eli Lilly, Genmab, GSK, Ideaya, Impact, Lixte, Ocular, Pharmasens, Revolution, Servier, Spyre, Synox. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Apotex, Beckman Coulter Diagnostics, Daiichi, Kymera, Merck, Prosomnus, Regeneron, Replimune, Roche, Sanofi. Read More
