BioPharm International Editors

Genentech (South San Francisco, CA) has informed healthcare professionals that an increased number of complaints have been received regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent.

The FDA is launching a pilot program to allow manufacturers to electronically file drug establishment registration and drug listing information, such as ingredients, labeling, and manufacturing information.

French biopharmaceutical company Trophos SA (Marseille, France) has appointed Damian Marron as chief executive officer.

Intas Biopharmaceuticals Limited (IBPL, Ahmedabad, India) has acquired the US-based biotechnology corporation, Biologics Process Development Incorporated (BPD Inc., Poway, CA).

Roche (Nutley, NJ) has introduced a flexible purchase program that will allow US businesses to maintain access to their own stockpile of Tamiflu for use in a pandemic situation, with limited upfront investment and more adaptability to deal with unknown factors inherent in pandemic planning.

The United States and the Socialist Republic of Vietnam have signed a memorandum of understanding (MOU) to enhance the safety of food, feed, drugs, and medical devices traded between the two nations.

Sanofi Pasteur (Lyon, France), the vaccines division of the Sanofi-Aventis Group, has announced the inauguration of a high-tech vaccine production facility in France to respond to soaring demand worldwide.

The 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 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 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 (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.

BN ImmunoTherapeutics, Inc. (Mountain View, CA), has initiated Phase 1/2 clinical studies with its therapeutic vaccine candidate against prostate cancer.

Significant improvement has been made since last year to enhance the safety of imported products, according to a new report released by the interagency working group on import safety.

Eden Biodesign, Ltd. (Liverpool, UK), has confirmed its expansion plans for Eden Biodesign, Inc., the Group’s US subsidiary, with the announcement of a facility in the highly coveted biotech hub, Research Triangle Park, NC.

The FDA has appointed David Horowitz as the assistant commissioner for policy.

ThromboGenics NV (Leuven, Belgium) and BioInvent International AB (Lund, Sweden) have entered into a license agreement with Roche (Basel, Switzerland) for their jointly developed anti-cancer agent TB-403.

Dave Mott, president and chief executive officer (CEO) of AstraZeneca’s (London, UK) biologics business unit, MedImmune (Gaithersburg, MD), has decided to leave the company at the end of July.

Ronald D. Snee, PhD, a principal with Tunnell Consulting (King of Prussia, PA), has been elected to the International Academy for Quality (IAQ).

SemBioSys Genetics, Inc. (Calgary, Canada) has demonstrated that its safflower-produced Apo AI(Milano) is functional in a widely accepted animal model.

Novartis (Basel, Switzerland) will acquire Protez Pharmaceuticals (Malvern, PA) for up to $400 million in cash.

3M Drug Delivery Systems (St. Paul, MN) has signed a non-exclusive license agreement with the Infectious Disease Research Institute (IDRI, Seattle, WA) in support of vaccine research for humanitarian efforts in developing countries.

Curtis (Curt) Rosebraugh, MD, has been appointed as the new director of the US Food and Drug Administration’s (FDA) Office of Drug Evaluation II.

The 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.

Daiichi Sankyo Co., Ltd. (Tokyo, Japan) will acquire U3 Pharma AG (Martinsried, Germany), a German biotechnology company focusing on research into antibodies for the treatment of cancer.

SciLog, 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).

The US Pharmacopeial (USP) Convention (Rockville, MD) has announced updates to the guideline for its pending monographs approach.

WuXi PharmaTech (Shanghai, China) has appointed Peng Wang, PhD as vice president of discovery biology.

The 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.

Bavarian Nordic, (Kvistgaard, Denmark), has initiated a Phase 1–2 clinical study with its HIV vaccine candidate, MVA-BN HIV multiantigen.

Cubist 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).