Minerva Neurosciences Inc. could regain at least some of June's disappointing initial public offering (IPO) and better align its pipeline candidates, thanks to enthusiasm over preclinical data from nonhuman primates – marmosets – in Parkinson's disease (PD), results that let shares (NASDAQ:NERV) close Tuesday at $6.49, up 8.2 percent. Read More
Gilead Sciences Inc. is intensifying its efforts to tackle the growing incidence of nonalcoholic steatohepatitis (NASH), buying privately held Phenex Pharmaceuticals AG's early stage farnesoid X receptor (FXR) program for up to $470 million. Read More
LONDON – The momentum continues to build behind chimeric antigen receptor (CAR) T cells, with Cardio3 Biosciences SA acquiring Oncyte, the immuno-oncology arm of privately held Celdara Medical LLC, in the second CAR T-cell deal of the new year. Read More
DUBLIN – Cytos Biotechnology AG was thrown a lifeline in the form of a new licensing deal for its Qbeta (Qb) virus-like particle (VLP) vaccine platform. Read More
HONG KONG – The pharmaceutical arm of Chinese conglomerate Fosun Group plans to channel its research and development efforts into biosimilars and generic chemicals with more than ¥5 billion (US$800 million) of investment in the coming years. Read More
The much-awaited guidance on interchangeability the FDA promised last year? It's now on the schedule for 2015, along with other biosimilar draft guidances on labeling, statistical approaches for evaluating analytical similarity data and implementation of the Biologic Price Competition and Innovation Act (BPCIA). Read More
SHANGHAI – China's Phagelux Inc. has made a deal with Delaware-registered Iveria Technologies Inc. to acquire several biodegradable polymer delivery systems for its phage technologies being developed for both human and agricultural uses. Read More
Avalanche Biotechnologies, Inc., of Menlo Park, Calif., said it filed a registration statement on Form S-1/A with the SEC relating to a proposed public offering of 2 million shares of its common stock. Read More
Kite Pharma Inc., of Santa Monica, Calif., reported that the European Commission has conferred orphan status on KTE-C19 for the treatment of diffuse large B-cell lymphoma. Kite has filed an investigational new drug application to conduct a phase I/II trial for KTE-C19 with the FDA, which has also granted the candidate orphan status. Read More
Alkermes plc, of Dublin, disclosed top-line results from FORWARD-1, one of a series of supportive clinical studies in the comprehensive FORWARD phase III pivotal program for the opioid modulator ALKS 5461, a once-daily, oral medicine for major depressive disorder (MDD). Read More
Leo Pharma A/S, of Ballerup, Denmark, said it submitted a new drug application to the FDA for calcipotriene/betamethasone dipropionate aerosol foam 0.005 percent/0.064 percent for the treatment of psoriasis vulgaris. Read More
