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.
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.
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.
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.
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.
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.
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.
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