Txcell SA, of Valbonne, France, said it concluded a milestone in its transfer of its manufacturing technology to contract manufacturer Mastercell for the European manufacturing of its product portfolio, including lead product Ovasave, with the completion of a series of defined validation runs. Read More

Amarin Corp. plc, of Dublin, recognized $26.4 million in net product revenue from Vascepa (icosapent) sales and $26.6 million in total revenue in the fourth quarter of 2015, reflecting a 24 percent increase over the previous quarter and 60 percent increase over the same quarter of the previous year's net product sales, and leading to full-year net product revenue of $81 million and full-year total revenue of $81.8 million, increases of 49 percent and 51 percent, respectively, over 2014. Read More

Avraham Pharmaceuticals Ltd., of Yavne, Israel, closed an investment round of about $4 million. Investors in the round include Yissum Research Development Co. Ltd., the technology transfer arm of the Hebrew University of Jerusalem, Pontifax, Clal Biotechnology Industries, Integra Holdings, Yissum's biotech holdings company, the Technion Research and Development Foundation Ltd. and others. Read More

TOKYO – Japan's Anges MG Inc. said a new inflammation treatment it has been developing since 1999 should reach the Japanese market as early as next year. Read More

ATLANTA – Speakers at the second day of the Accelerating Osteoarthritis (OA) Clinical Trials Workshop co-sponsored by the Arthritis Foundation and the FDA pointed to a wealth of trials examining drug, surgical and other interventions to treat the disease, citing more than 500 studies in the U.S. and five dozen in Europe under the sponsorship of dozens of biopharmas and academic institutions. Read More

Now that it has the funding to launch its part of the Precision Medicine Initiative (PMI), the NIH awarded a contract to Vanderbilt University to launch the first phase of a cohort of 1 million volunteers who will form the foundation of a massive research effort to transform the understanding and practice of medicine. Read More

DUBLIN – Abivax SA has seen enough of an efficacy signal in a phase IIa trial of its first-in-class HIV drug ABX464 to warrant another phase IIa, to test its potential to delay viral rebound after cessation of therapy. "It's a proof of concept – it's a small phase IIa again," Abivax's chief medical officer, Jean-Marc Steens, told BioWorld Today. Read More

Somewhat like a vaccine for HIV, a cure has been on the horizon yet out of reach for a frustratingly long time. "I think it's fair to say that the score card is not very impressive," Mario Stevenson, chief of the division of infectious disease at the University of Miami Medical School, told the audience at a the plenary session of the Conference on Retroviruses and Opportunistic Infections (CROI), which is going on in Boston this week. Read More

In shooting for the moon with cancer research, the FDA must pull down the silos between researchers and breach the internal barriers separating its own oncology experts on drugs, diagnostics and devices, acting FDA Commissioner Stephen Ostroff told a House Appropriations subcommittee Thursday. Read More

Rigel Pharmaceuticals Inc., of South San Francisco, said it started a phase II trial of fostamatinib, its oral SYK inhibitor, in patients with chronic autoimmune hemolytic anemia. Read More