Tesorx Pharma LLC, of San Francisco, and Aska Pharmaceutical Co. Ltd., of Tokyo, said, following a recently completed pharmacokinetic study, they will start preparing for an upcoming phase I/IIa trial of Tesorx's oral testosterone product, TSX-011, expected to be conducted in the U.S. and to include Japanese patients to expedite development in both regions. Read More

Alkermes plc, of Dublin, reported total revenues of $191.8 million for the quarter, falling short of analyst estimates of $197.3 million. Read More

Matinas Biopharma Holdings Inc., of Bedminster, N.J., named Dominick DiPaolo senior vice president of quality and regulatory compliance. Read More

Flexion Therapeutics Inc., of Burlington, Mass., priced a $175 million convertible senior note offering. Read More

The U.K.'s National Institute for Health and Care Excellence (NICE) published its final appraisal determination recommending Blincyto (blinatumomab), the bispecific antibody from Thousand Oaks, Calif.-based Amgen Inc. as an option for treating adults with Philadelphia-chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukemia, on the basis of the discount agreed in the patient access scheme. Read More

PERTH, Australia – The pharma industry largely supports the Therapeutic Goods Administration's (TGA) update to its orphan drug regulations, expected to become effective July 1, though industry stakeholders offered some suggestions for modifications, mostly regarding eligibility criteria for orphan designation and the time lapse for the validity period. Read More

Bridgebio Pharma Inc. disclosed the second company in its growing portfolio of subsidiaries targeting genetic diseases, endowing Eidos Therapeutics with $27 million to advance its lead compound, AG-10, for the treatment of transthyretin (TTR) amyloidosis. Read More

With just-approved PARP inhibitor Zejula (niraparib) making its way in the marketplace, Tesaro Inc. has turned its phase I dose-escalating trial with anti-PD-1 antibody TSR-042 into a registration experiment in patients with metastatic, microsatellite instability (MSI)-high endometrial cancer who have progressed following one or two prior chemotherapy treatments. Read More

The FDA is one step closer to having its next commissioner. Read More

Zogenix Inc., of Emeryville, Calif., said the last patient was randomized in the treatment period of Study 1, its first phase III trial testing ZX-008 (low-dose fenfluramine) as an adjunctive treatment for seizures in children and young adults with Dravet syndrome. Read More