Galectin Therapeutics Inc., of Norcross, Ga., said it completed enrollment in its phase II trial of GR-MD-02, a complex carbohydrate targeting galectin-3, in patients with non-alcoholic steatohepatitis with advanced fibrosis. The NASH-FX trial enrolled a total of 30 liver biopsy-confirmed patients and is assessing fibrosis using multiparametric magnetic resonance imaging as the primary endpoint. Top-line results are expected by the end of September. Read More
United Therapeutics Corp., of Silver Spring, Md., appointed Michael Benkowitz president and chief operating officer, effective June 26; Martine Rothblatt will resume her previous role as CEO. Read More
Biofrontera AG, of Leverkusen, Germany, said the FDA approved the combination of topical drug Ameluz (BF-200 ALA) and medical device BF-Rhodoled for photodynamic therapy treatment of mild to moderate actinic keratosis on the face and scalp. The approval covers lesion-directed as well as field-directed treatment. Ameluz received EMA approval in December 2011, with BF-Rhodoled approved as a medical device in the EU in November 2012. Read More
Viriom Inc., of San Diego, said it raised $4.7 million of equity and non-equity financing, including a three-year grant of 150 million rubles (US$2.35 million) from the Skolkovo Foundation, for the development of fixed-dose combinations and long-acting injection formulations of Elpida (elpivirine), its non-nucleoside reverse transcriptase inhibitor for HIV/AIDS. Read More
After years of taking a back seat to research efforts in indications such as cardiovascular disease, cancer and pulmonary disease, the gastrointestinal space is hot. Read More
Wall Street speculation that a pending ex-U.S. partnership "could lead into something greater or bigger" helped bump shares of Celator Pharmaceuticals Inc., but CEO Scott Jackson told BioWorld Today the promise of more color than expected on Vyxeos at next month's American Society of Clinical Oncology meeting may have helped, too. Read More
A day after settling with two of seven drugmakers seeking to advance generic challenges to its top-selling product, Xyrem, Jazz Pharmaceuticals plc moved to acquire Alizé Pharma II, the developer of a pegylated recombinant L-asparaginase program that could bolster Jazz's second largest commercial program, Erwinaze. Read More
DUBLIN – Novimmune SA closed a CHF30 million (US$31 million) funding round, taking the total cash it has raised this year to CHF60 million and its lifetime total to more than CHF300 million. Read More
