Teva Pharmaceutical Industries Ltd. is raising its bet in the migraine-fighting market by buying Labrys Biologics Inc. for $200 million up front and up to $625 million in pre-launch milestone payments. The single-compound company's once-monthly injectable migraine prevention drug, LBR-101, could capture $2 billion to $3 billion in sales, according to Teva estimates, adding a lucrative new dimension to its growing portfolio of pain treatments. Read More
In a move that could potentially signal greater flexibility by regulators in reviewing groundbreaking drugs with new mechanisms of action in rare diseases with clear unmet medical need, the FDA provided guidance for a potential regulatory path, under accelerated approval, for drisapersen, the lead program in development by Prosensa Holding NV to treat Duchenne muscular dystrophy (DMD). Read More
SHANGHAI – Hutchinson China Meditech Ltd. (Chi-Med) has struck a new deal with its joint venture partner of 13 years, Shanghai Traditional Chinese Medicine Co. Ltd. (STCM), to exclusively sell six prescription drugs in China. Chi-Med's commercial operations help to fund its extensive R&D efforts, with seven candidates in the clinic for oncology, immunology and inflammation. Read More
HONG KONG – Chinese biopharmaceutical companies are upping the ante in the development of biological drugs and biosimilars of existing bestsellers, many of them looking to capitalize on the huge domestic market. Read More
SHANGHAI – It is no secret that China is heavy on generics and light on innovation. But what happens when a successful drugmaker with deep pockets and a visionary chairman decides to take on drug discovery? Haiyan Pharmaceutical Technology Co. Ltd., the drug development subsidiary of the Yangtze River Pharmaceutical Group (YRP), and its team of executive returnees are set to prove that innovation can be implanted anywhere, even in a risk adverse generics maker. Read More
HONG KONG – Adding the oral molecular targeted therapy Afinitor (everolimus, Novartis AG) to conventional chemotherapy plus anti-HER2 treatment reduced the risk of progression of human epidermal growth factor receptor-2 (HER2)-positive advanced breast cancer resistant to Herceptin (trastuzumab, Roche AG) by 22 percent and may provide clues to the mechanisms underlying Herceptin resistance, researchers reported. Read More
GW Pharmaceuticals plc, of London, disclosed an agreement with New York state to initiate clinical trials using cannabidiol (CBD) to treat children diagnosed with epilepsy who suffer from seizures and other medical complications. New York will be the second state in the U.S. to initiate trials for CBD in children who have not been treated successfully by other methods. Read More
Bristol-Myers Squibb Co., of New York, and Syngene International Ltd., of Bangalore, India, extended their drug discovery and development collaboration in India for five years. Financial terms were not disclosed. The collaboration has produced six drug candidates to advance to first-in-human studies. Read More
Arena Pharmaceuticals Inc., of San Diego, said it started dosing in a phase Ib trial of APD334, an oral candidate designed to target sphingosine 1-phosphate subtype receptor for treating autoimmune diseases. The study will evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses in up to 96 healthy adult volunteers. Read More
Nanotherapeutics Inc., of Alchua, Fla., has secured a $30 million loan facility from Hercules Technology Growth Capital Inc. to support efforts to expand its manufacturing infrastructure. The cGMP manufacturer of preclinical and clinical-stage biopharmaceuticals said it intends to partner with government and other companies, as well as continue to fund the development of its biodefense-focused internal pipeline. Read More
Viralytics Ltd., of Melbourne, reported additional interim results from its ongoing phase II CALM trial testing oncolytic immunotherapy candidate Cavatak in patients with stage IIIc and stage IV malignant melanoma, with data showing that 19 of 51 (37 percent) evaluable patients demonstrated immune-related progression-free survival at six months after first dose. Read More