LONDON – The Pew Charitable Trusts is stepping in to fill a gap in the international fight against antimicrobial resistance (AMR), with the formation of a virtual laboratory that will bring together disparate datasets and leading experts in an open platform for use by industry, academics and nonprofits. Read More
Activating mutations in the BRAF kinase, such as those targeted by melanoma drug Zelboraf (vemurafenib, Roche Holding AG), are a well-known cause of cancer. Read More
Omeros Corp., of Seattle, said the FDA granted orphan designation to OMS-721, its lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, in immunoglobulin A (IgA) nephropathy. Read More
Infinity Pharmaceuticals Inc., of Cambridge, Mass., said it completed the monotherapy dose-escalation portion of its four-part phase I trial testing IPI-549 in patients with advanced solid tumors. Read More
Neovacs SA, of Paris, said it closed its €6 million (US$7.1 million) share capital increase via private placement. Proceeds will support the company's development plan for IFNalpha Kinoid, including completion of a phase IIb trial in lupus, a phase IIa trial in dermatomyositis and preclinical proof-of-concept testing in type 1 diabetes. Read More
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is asking for industry feedback on whether Australia should change its naming mechanisms for biosimilars and biologics and if it should adopt practices of other international regulators. Read More
Mallinckrodt plc said it plans to acquire Infacare Pharmaceutical Corp., the developer of a late-stage severe jaundice treatment, for $80 million up front plus up to $345 million in potential milestone payments. If approved, the FDA fast-tracked candidate, stannsoporfin, could potentially be used to reduce or prevent the need for phototherapy, risky exchange transfusions and the incidence of pricey hospital readmissions. Read More
Two-year-old IFM Therapeutics Inc. became the latest biopharma unicorn, as Bristol-Myers Squibb Co. (BMS) picked up the Boston-based company for $300 million up front and another $1.01 billion in potential development, regulatory and sales milestones for each of the first products from the deal's two oncology programs. IFM is eligible for more contingent milestone payments for additional products that emerge from the programs. Read More
Enanta Pharmaceuticals Inc. CEO Jay Luly told BioWorld that, with the FDA's approval for Abbvie Inc.'s hepatitis C virus (HCV) drug Mavyret (glecaprevir/pibrentasvir), his firm is one milestone away from hitting every goal set by the deal. Read More
