Despite struggling with extrapolation, the FDA's Oncologic Drugs Advisory Committee (ODAC) unanimously supported approval of two biosimilars referencing Roche Holding AG's Avastin and Herceptin.

Mayo Clinic is expanding its clinical territory into drug discovery and development for the first time by partnering with artificial intelligence (AI) firm Nference to create Qrativ. Virtual for now, the startup plans to forge collaborations with third parties and to in-license drug candidates – either way, applying a data-driven approach that combines a range of AI techniques.

The decision by Johnson & Johnson (J&J) to use a priority review voucher for the submission of the biologics license application for guselkumab apparently paid off. The drug, branded Tremfya, gained FDA approval late Thursday, four months prior to its estimated PDUFA date of Nov. 17.

Sarepta Therapeutics Inc., of Cambridge, Mass., appointed Douglas S. Ingram as president and CEO.

Amgen Inc., of Thousand Oaks, Calif., reported results from the final analysis of the phase III ASPIRE trial, showing it met the key secondary endpoint of overall survival (OS), with proteasome inhibitor Kyprolis (carfilzomib) in combination with Revlimid (lenalidomide, Celgene Corp.) and dexamethasone (KRd), reducing the risk of death by 21 percent over lenalidomide and dexamethasone alone (Rd) (median OS 48.3 months for KRd vs. 40.4 months for Rd, HR = 0.79, 95 percent CI, 0.67 – 0.95).

Digestive Care Inc., of Bethlehem, PA, and its marketing partner, Chiesi USA Inc., of Cary, NC, said the FDA approved a labeling revision to include gastrostomy tube administration of the 4,000 USP lipase units capsule of Pertzye (pancrelipase) for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Amicus Therapeutics Inc., of Cranbury, N.J., said it priced an underwritten offering of 18.3 million shares of its common stock at $12.25 each with gross proceeds expected to be $225 million.

Enterome Bioscience SA and Nestlé Health Science SA are creating a new startup – Microbiome Diagnostics Partners (MDP) – which is poised to focus on the development of a test for inflammatory bowel disease (IBD) and finding additional biomarkers.

PERTH, Australia – Dimerix Ltd. reported positive phase IIa data with its lead program, DMX-200, in chronic kidney disease.

Can machine learning glean useful information from whole genome analysis faster than conventional approaches? And, more crucially, can that help lead to better treatment for cancer patients? A new study published by researchers at the New York Genome Center (NYGC), The Rockefeller University and IBM suggests that the answer to those questions may be yes.