A new oral HER2-directed breast cancer therapy from Bayer AG, and its companion diagnostic from Thermo Fisher Scientific Inc., have been approved by the U.S. FDA. Hyrnuo (sevabertinib), a reversible tyrosine kinase inhibitor, was greenlit by the agency for adults with locally advanced or metastatic non-squamous advanced HER2-mutant non-small-cell lung cancer. Read More
Two Flagship Pioneering Inc. biopharma companies founded in the last five years and focused on proteomic and genomic technologies entered agreements to help discover new therapeutics for respiratory and liver diseases under a framework collaboration with GSK plc. Under that agreement, Profound Therapeutics Inc. and Quotient Therapeutics Inc. would use their platform technologies to discover novel proteins and targets for developing drugs to treat chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis, with Quotient taking on a third indication with metabolic dysfunction-associated steatohepatitis. Read More
It’s the biological resource that keeps on giving, and now UK Biobank has released the final tranche of data on the levels of 249 metabolites in the blood of its half a million participants. Read More
Sandoz Inc. came out the big winner Nov. 18 when the U.S. Court of Appeals for the Federal Circuit wiped out $39 million in infringement damages a jury had awarded to Allergan plc. Sandoz overcame “the doubly high burden of persuading us to overturn a jury verdict of no invalidity,” the appellate court said in its precedential opinion. Read More
Could GLP-1 receptor agonists (GLP-1RAs), already used in obesity and diabetes, be repurposed as drugs to slow aging? Hong Kong, one of the places in the world with the highest human longevity, is also home to a scientific study on the effects of GLP-1RAs. For the first time, scientists at the Chinese University of Hong Kong (CUHK) have assessed their pharmacological potential in later life using a multiomics preclinical approach. Read More
U.S. and European organ-on-a-chip specialty biotechnology companies are driving development of organ-on-a-chip technologies, fueled by the U.S. FDA’s decision to phase out animal testing for investigational new drugs. Read More
New hires and promotions in the biopharma industry, including: Ability, Autoimmunity, Avenzo, Elicio, Hyloris, Minerva, Neurona, Nuvig, Resverlogix. Read More
Biopharmas raising money in public or private financings, including: AI Proteins, Fibrobiologics, Genmab, HCW, Hemostemix, Lifordi, Mendus, Nervgen, Nuvalent, Olema, Seragene, Skeletalis. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Abbvie, Arrowhead, Insmed, Merck, Oncolytics, Regeneron, Roche. Read More
