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APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced that it has entered into a commercialization, manufacture and supply agreement with Teva Pharmaceutical USA, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd., to manufacture and market Gemcitabine HCI for Injection. Under the terms of the agreement APP has been granted a license to market Gemcitabine HCI for Injection in 200 mg and 1 g single dose vials during the 180 day Hatch Waxman exclusivity period. APP plans to launch Gemcitabine immediately.

Merck reported that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, demonstrated significantly higher sustained virologic response (SVR)1 rates in adult patients who previously failed treatment (treatment-failure; HCV RESPOND-2) and in adult patients who were new to treatment (treatment-naïve; HCV SPRINT-2) for chronic hepatitis.

The European Vaccine Initiative, a product development partnership supporting the development of vaccines against diseases of poverty, has brought together to Brussels manufacturers, biotech companies, public/academic researchers, and funding agencies to identify the gaps in vaccine research and development (R&D) in Europe. In addition, a working group, set up in the yesterday’s meeting, will formulate an agenda for action to pave the way for putting in place a permanent infrastructure securing vaccine R&D and manufacturing in Europe. A separate meeting will be organised with European regulatory authorities to discuss how their contributions can be integrated into the activities of this working group.

Nycomed announced that it is significantly expanding its presence in China through the acquisition of a majority stake in Guangdong Techpool Bio-Pharma Co., Ltd. (Techpool), a fast-growing Chinese bio-pharmaceutical company based in Guangdong. Techpool, founded in 1993, specialises in the research, development, manufacturing and marketing of biologic drugs derived from natural sources.

Biocon, Asia's premier biotechnology company, and Pfizer Inc., the world's leading biopharmaceutical company, today announced that they have entered into a strategic global agreement for the worldwide commercialization of Biocon's biosimilar versions of Insulin and Insulin analog products:  Recombinant Human Insulin, Glargine, Aspart and Lispro.  Pfizer will have exclusive rights to commercialize these products globally, with certain exceptions, including co-exclusive rights for all of the products with Biocon in Germany, India and Malaysia.  Pfizer will also have co-exclusive rights with existing Biocon licensees with respect to some of the products, primarily in a number of developing markets.

Novartis announced today an agreement with Synthetic Genomics Vaccines Inc. (SGVI) to apply "synthetic genomics" technologies to accelerate the production of the influenza seed strains required for vaccine manufacturing. The seed strain is the starter culture of a virus, and is the base from which larger quantities of the vaccine virus can be grown. The three-year agreement, supported by an award from the U.S. Biomedical Advanced Research and Development Authority (BARDA), could ultimately lead to a more effective response to seasonal and pandemic flu outbreaks.

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