Privately held Lycera Corp. attracted its second major partner – and a potential buyer – in an exclusive global collaboration with Celgene Corp. focused on advancing Lycera's preclinical RORgamma agonists for cancer immunotherapy and a clinical-stage candidate, LYC-30937, in development for IBD. Read More
The first of two protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors to lower low-density lipoprotein cholesterol (LDL-C) made its way with favor through the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), setting the stage for the second – maybe more fraught – PCSK9, which EMDAC will evaluate today. Read More
Sage Therapeutics Inc. shares (NASDAQ:SAGE) rose 15.4 percent to $86.71 on Tuesday after hitting a 52-week high on news that the company is accelerating plans to begin testing its most advanced compound, SAGE-547, in a new trial for the treatment of postpartum depression before the end of this year. Read More
LONDON – A workshop convened Monday by the EMA to discuss major issues related to the approval of bacteriophage therapies –or phagotherapies – as medicinal products heard from two companies that have developed GMP standard facilities for their manufacture. Read More
DUBLIN – Cosmo Pharmaceuticals SA is spinning out its dermatology unit, Cassiopea SpA, as an independent company, which plans to go public on the Six Swiss Exchange in Zurich. Read More
Bringing the patient perspective in drug development to a new level, the FDA issued its first draft guidance based on a guidance proposed by a patient advocacy group – in this case, the Parent Project Muscular Dystrophy (PPMD). Read More
SHANGHAI – New out of the gate, Suzhou Neupharma Co. Ltd., has put its first candidate, RX-108, into clinical trials. Like many companies in China with global ambitions, Neupharma is collecting its first-in-human data in Australia while it waits for its trials to get a green light in China. Read More
Oncosec Medical Inc., of San Diego, said it closed its registered direct offering of about 2.5 million shares of its common stock at $5.50 per share. The gross proceeds were approximately $13.6 million. Read More
Aytu Bioscience Inc., of Englewood, Colo., said it entered an agreement with Jazz Pharmaceuticals plc, of Dublin, to acquire the rights to Prostascint, an imaging agent used to detect the extent and spread of prostate cancer. Read More
Angion Biomedica Corp., of Uniondale, N.Y., said the FDA issued a clearance letter allowing the company to begin its phase II GUARD (GUard Against Renal Damage) trial of BB3 in patients at risk for acute kidney injury. Read More
Aegerion Pharmaceuticals Inc., of Cambridge, Mass., appointed David Aubuchon, current chief accounting officer, acting chief financial officer. Read More
