The FDA's Endocrinologic and Metabolic Drugs Advisory Committee meets Thursday to review Saxenda (liraglutide) to treat obesity. If the drug passes muster, it could give Novo Nordisk A/S a new entry into the market for weight loss therapies and extend use of the drug, which is already sold at a lower dose as Victoza for type 2 diabetes. Read More
Following up the early U.S. approval of in-licensed Beleodaq (belinostat) for peripheral T-cell lymphoma, Spectrum Pharmaceuticals Inc. offered good news from another deal, making public the plans to push SPI-2012, a long-acting granulocyte stimulating factor (GCSF), into phase III trials next year. Read More
TOKYO – The Japanese arm of Swiss pharma giant Novartis AG admitted to government regulators it failed to report more than 2,500 cases of serious side effects in patients who had received its leukemia and cancer drugs. Read More
NEW DELHI – India's expected share in the global market for biosimilars is between 20 percent and 25 percent in the next five years, but analysts caution that the country needs to improve its funding, innovation capabilities and regulation for large molecule drugs. Read More
SHANGHAI – Upstart Beigene Co. Ltd. wowed observers last year when it landed two deals with Merck Serono, a division of Merck KGaA, which licensed global rights to two of their preclinical oncology candidates for a combined value of close to $500 million. Read More
Shaking up the color wheel, the FDA released what it's calling the Purple Book – a listing of biologics that may serve as reference products for biosimilars and interchangeables. Read More
Aerie Pharmaceuticals Inc., of Bedminster, N.J., said that Deerfield Management Co. is investing $125 million through a senior secured convertible notes financing, which is expected to be funded before the end of September. Read More
Biondvax Pharmaceuticals Ltd., of Nes Ziona, Israel, said it has been awarded NIS4.87 million (US$1.34 million) by the Chief Scientist in the Ministry of Economy for the continued development of its universal influenza vaccine. The grant will be used to promote the company's effort toward a phase III trial with its universal vaccine. Read More
C3 Jian Inc., of Los Angeles, successfully completed an initial phase II trial for C16G2, the first peptide therapeutic derived from its pheromone signaling platform. Read More
Chimerix Inc., of Durham, N.C., reported results from in vitro and phase II studies of oral antiviral brincidofovir to treat adenovirus and to prevent and treat cytomegalovirus (CMV). Read More
Valeant Pharmaceuticals International Inc., of Laval, Quebec, expanded its Bausch + Lomb manufacturing facility, adding 120 new jobs in Rochester, N.Y., to produce its silicone hydrogel contact lens, Bausch + Lomb ULTRA. Read More
