Previously treated high-risk chronic lymphocytic leukemia patients saw a significantly better overall response rate when adding TG Therapeutics Inc.'s glycoengineered anti-CD20 candidate, TG-1101 (ublituximab), to Imbruvica (ibrutinib) during a phase III study called Genuine. Read More

Arca Biopharma Inc., of Westminster, Colo., said the 175th patient has been randomized into GENETIC-AF, a seamless design phase IIb/III trial evaluating the beta blocker and mild vasodilator Gencaro (bucindolol hydrochloride) as a potential treatment for atrial fibrillation. Read More

Tigenix NV, of Leuven, Belgium, received the day 180 list of outstanding issues from the Committee for Medicinal Products for Human Use of the EMA and expects to receive a marketing decision Cx601 in 2017. Read More

SHANGHAI – Hutchison Medipharma Ltd. (Chi-Med) announced its first phase III win with fruquintinib, a targeted VEGFR inhibitor studied as a third-line therapy in 416 Chinese patients with colorectal cancer (CRC). Read More

DUBLIN – Ingeneron Inc. has secured $20 million in equity investment from its clinical collaborator Sanford Health, enabling it to conduct U.S. clinical trials of its point-of-care cell therapy treatment in several indications. Read More

TOKYO – Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is looking to play an active role in achieving "rational medicine" in the country, the idea that a patient-centric system should optimize care from the patient's point of view based on the latest scientific knowledge. Read More

HONG KONG – In a final ruling, the U.K.'s High Court of Justice ruled in favor of Tokyo-based Fujifilm Kyowa Kirin Biologics Co. Ltd. in a patent revocation proceeding against Abbvie Inc., which has been fighting to protect its blockbuster Humira (adalimumab). Read More

Novel analogues of a class of antibacterial compounds isolated from soil bacteria could lead to the development of urgently needed new treatments for tuberculosis (TB), according to the findings of a study led by Australian researchers at the University of Sydney. Read More

Australia's Therapeutic Goods Administration (TGA) updated its 2013 guidance on stability testing of prescription drugs. The update provides links to applicable EU guidelines and modifies specific testing requirements for biologics. Read More