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 advanced HER2-mutant non-small-cell lung cancer. The tumors must have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations and patients must have received a prior systemic therapy. The FDA granted the drug, previously known as BAY-2927088, its breakthrough therapy designation in February. The priority NDA was accepted by the FDA in May and granted priority review. Thermo Fisher’s Ion Torrent Oncomine Dx Target Test is Hyrnuo’s companion diagnostic.

GSK-Flagship deal validates Profound, Quotient discovery platforms

Two Flagship Pioneering biopharma companies founded in the last five years entered agreements to help discover new therapeutics for respiratory and liver diseases under a framework collaboration with GSK plc. Under that agreement – signed between GSK and Flagship in 2024 – Profound Therapeutics Inc. and Quotient Therapeutics Inc. would each earn $150 million up front to 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. GSK has the exclusive option to advance into clinical studies any of the programs, with each one worth up to $720 million, inclusive of the up-front payment, as well as development and commercial milestones, and preclinical funding and tiered royalties.

UK Biobank delivers largest metabolomics dataset of 500K profiles

It’s the biological resource that keeps on giving, and now UK Biobank (UKB) has released the final tranche of data on the levels of 249 metabolites in the blood of its half a million participants. The metabolomic data “represent the next link in the chain” said Rory Collins, chief executive of UKB. “When combined with the UK Biobank genetic, proteomic and imaging information, these data open up a new dimension of discovery, allowing scientists to study the combined effect of genes, proteins and environmental factors on health,” he said.

Multiomic study shows antiaging effects of GLP-1RAs

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 have assessed their pharmacological potential in later life using a multiomics preclinical approach.

US, European biotechs lead budding organ-on-a-chip market

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. With a handful, but growing number of biotechs gaining traction, some big pharmaceutical companies are entering the organ-on-a-chip sector through partnerships, including with forerunners such as Emulate Inc., Mimetas BV, CN Bio Innovations Ltd., Hesperos Inc. and Organovo Holdings Inc.

Fed Circuit lets Sandoz off $39M hook

Sandoz Inc. came out the big winner this week 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. The court agreed with Sandoz that the hair-growth patent Allergan alleged the generics company had infringed lacked an adequate written description.

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