News

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.

As the use of disposable bioprocessing equipment has increased, a new question is gaining prominence: What is the best way to dispose of the equipment after use?

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.

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.

US 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.

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).

Novavax, Inc. (Rockville, MD) has received positive results from an immunogenicity study in ferrets inoculated with the company’s trivalent seasonal influenza vaccine candidate made using its proprietary virus-like particle (VLP) technology.

Zelos Therapeutics, Inc. (West Conshohocken, PA) and Aegis Therapeutics LLC (San Diego, CA) have announced a collaboration for the development of an intranasal spray formulation of the proprietary parathyroid hormone (PTH) analog ZT-031 [Ostabolin-C, cyclic PTH-(1-31)].

Baxter’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.

The 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.

The 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).”

On April 9, 2008, Genzyme Corporation (Framingham, MA) announced a recall of three lots of its organ-rejection antibody, Thymoglobulin, because of stability concerns.

Frank M. Torti, MD, has been appointed principal deputy commissioner and first ever chief scientist at the FDA.

The National Institute for Bioprocessing Research and Training (NIBRT, Dublin, Ireland) has entered into a new research collaboration with US pharmaceutical company Eli Lilly (Indianapolis, IN).

The FDA issued a warning letter to Merck and Co. (Whitehouse Station, NJ) on April 28, citing numerous GMP violations at Merck’s vaccine production operations in West Point, PA.

DSM Biologics (Heerlen, the Netherlands), and Upfront Chromatography A/S (Copenhagen, Denmark) have announced a collaboration to optimize Upfront’s new, fully disposable chromatography system for use with DSM's proprietary manufacturing technology.

The US FDA has embarked on a multiyear initiative to hire hundreds of individuals with science and medical backgrounds to help meet the agency?s responsibilities to ensure the safety and efficacy of human and veterinary drugs, biological products, medical devices, food, and cosmetics.