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.

Spectrum Pharmaceuticals Inc., of Henderson, Nev., reported total revenue of $34 million in the second quarter.

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.