For a whopping $7.1 billion up front, Roche AG is buying Telavant Holdings Inc., a firm that is owned by Roivant Sciences Ltd. and Pfizer Inc. The deal also includes $150 million on the back end, and Roche gains rights to develop, manufacture and commercialize a fully human monoclonal antibody targeting tumor necrosis factor-like ligand 1A, RVT-3101, for treating inflammatory bowel disease (IBD) and possibly other diseases in the U.S. and Japan. Pfizer retains the rights for the rest of the world. Read More
Harpoon Therapeutics Inc. provided updated interim monotherapy data from 71 patients in its phase I/II trial testing HPN-328 in small-cell lung cancer (SCLC) and other neuroendocrine tumor types in a poster at the European Society of Medical Oncology Congress (ESMO). Wall Street immediately began comparing the compound, which takes aim at delta-like ligand 3 (DLL3) with a similar prospect from Amgen Inc. that recently yielded promising results. Read More
Out of the 30 companies comprising BioWorld’s Drug Developers Index (BDDI), 22 stocks saw a decrease in their stock prices in September, while two remained stable, and six showed positive gains. At the end of the third quarter, 80% of companies on BDDI experienced a decline in their stock values, with only six recording an increase. Read More
Chimeric Therapeutics Ltd.‘s chlorotoxin (CLTX) CAR T therapy, CHM-1101, which is derived from scorpion toxin, saw a disease control rate of 55%, exceeding the historical disease control rates of 20% to 37% in heavily pre-treated patients with glioblastoma. Read More
GSK plc is the latest pharma giant to bite the “magic bullet” of antibody-drug conjugate (ADC) drugs, promising to pay the Chinese immunotherapy developer Hansoh Pharmaceutical Co. Ltd. $85 million up front and over $1.4 billion in milestone payments in a licensing deal for HS-20089. Read More
Some cancers with a poor prognosis have had no new treatments in decades. Advances in the genetic characterization of these tumors now offer a range of possibilities for the development of new therapies that could completely change the quality of life and survival of these patients. Read More
The U.S. FDA is once again revising its guidance on how drug and device makers can share scientific reprints and reference texts with health care providers regarding off-label uses of their approved or cleared products. Read More
With an eye on increasing U.S. competitiveness and expanding the opportunities of technology hubs beyond those already established on the country’s two coasts, the Biden administration designated 31 communities, out of more than 370 applicants, as Regional Innovation and Technology Hubs. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeon, Almirall, Amgen, Apellis, Arcutis, Astrazeneca, Avadel, Dermavant, Dr. Reddy's Eli Lilly, Foundation, Gilead, Journey, Merarini, Merck & Co., Novartis, Novo Nordisk, Petros, Riboscience, TME. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avenacy, Celltrion, Cybin, Erydel, Fuji, Mithra, Quince, Small. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Celltrion, Ipsen, Lipella, Pfizer, Regeneron, Rise, Sanofi, Spago, Sumitomo. Read More
