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BIO and Battelle Release State-By-State Analysis of Bioscience Trends
July 9th 2008The nation's bioscience industry continues to grow as states and regions vie to attract high-wage jobs, according to a study released on June 18, 2008, by Battelle (Columbus, OH) and the Biotechnology Industry Organization (BIO, Washington, DC).
Boehringer Ingelheim to Acquire Actimis Pharmaceuticals
July 9th 2008Boehringer Ingelheim GmbH (Ingelheim, Germany) will acquire Actimis Pharmaceuticals, Inc. (San Diego, CA), through a structured buyout in which Boehringer Ingelheim will acquire shares of Actimis depending on the achievement of several successive milestones with Actimis’s leading asthma compound AP768.
Peregrine Awarded DTRA Contract to Develop Bavituximab for Viral Hemorrhagic Fevers
July 9th 2008Peregrine Pharmaceuticals, Inc. (Tustin, CA), has entered into a five-year contract worth up to $44.4 million to test and develop bavituximab and an equivalent fully human antibody as potential broad-spectrum treatments for viral hemorrhagic fever infections.
PacificGMP and Pacific Biopharma Group to Create cGMP CMO in China
July 9th 2008PacificGMP (San Diego, CA) and Pacific Biopharma Group (San Diego, CA) have signed a merger agreement to develop a cGMP (current good manufacturing practices) biologics contract manufacturing organization (CMO) in Taizhou, China.
Wyeth Receives Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine
June 11th 2008The US Food and Drug Administration (FDA) has granted Fast Track designation to Wyeth Pharmaceuticals’ (Collegeville, PA) investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers.
GE Healthcare Licenses Single-Use Purification Platforms from SciLog
June 11th 2008SciLog, Inc. (Middleton, WI), a privately held company that designs and manufactures computer-controlled bioprocessing equipment, has announced the signing of a patent licensing agreement with GE Healthcare (Somerset, NJ).
Sweeping Changes Ahead for Biotech, Says Ernst & Young
June 11th 2008The global biotechnology industry achieved record levels in financing and deal making in 2007, as investors and strategic partners showed strong confidence in the sector amid tightening global financial conditions that will continue to test the industry in 2008.
FDA Approves Expanded Adjuvant Indications for Herceptin
May 23rd 2008US Food and Drug Administration's Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.
Leached Impurity Found in Cubicin Stored in Cardinal Health’s ReadyMED Pumps
May 8th 2008Cubist Pharmaceuticals, Inc. (Lexington, MA) informed healthcare professionals on April 4 that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. (Dublin, OH).
Heparin Products the Target of Deliberate Adulteration, Says Baxter CEO
May 8th 2008Baxter’s heparin products appear to have been the target of a deliberate adulteration scheme, Baxter (Deerfield, IL) CEO Robert L. Parkinson said on April 29, 2008, in testimony before the US House of Representatives’ Committee on Energy and Commerce, Subcommittee on Oversight and Investigations.
Robin Robinson Named First Director of BARDA
May 8th 2008The Department of Health and Human Services has announced the selection of Robin Robinson, PhD, as the first director of the Biomedical Advanced Research Development Authority (BARDA), which was established in 2007 in the HHS Office of the Assistant Secretary for Preparedness and Response.
FDA Finalizes CMC Guidance for Gene Therapy INDs
May 8th 2008The FDA has issued its guidance for chemistry, manufacturing, and control information that is included in investigational new drug applications (INDs) for gene therapies, called “Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs).”