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.
The contamination of heparin is far more widespread, and began earlier, than first believed, FDA officials announced on April 21, 2008.
Takeda Pharmaceutical Company Limited (Osaka, Japan) will acquire Millennium Pharmaceuticals, Inc. (Cambridge, MA), for approximately $8.8 billion through a cash tender offer of $25.00 per share.
BAC BV, the Bio Affinity Company (Naarden, The Netherlands), has entered into a license and supply agreement with Hematech, Inc. (Sioux Falls, SD), a subsidiary of Kirin Pharma, that specializes in the production of human antibodies in transgenic cows.
Shobha Parthasarathi, PhD, has joined the North Carolina Biotechnology Center (Research Triangle Park, NC) as technology development director in the Business and Technology Development unit.
In what CEO and Chairman Fred Hassan is calling “tough actions that are needed to respond to a tough situation,” Schering-Plough (Kenilworth, NJ) has announced plans to eliminate 5,500 jobs (10% of its workforce).
American Health Packaging (AHP, Valley Forge, PA), B. Braun Medical Inc. (Irvine, CA), and Covidien (Mansfield, MA), have all announced voluntary recalls of heparin products after being notified by their supplier, Scientific Protein Laboratories LLC (SPL, Waunakee, WI), of a nationwide recall of heparin sodium USP active pharmaceutical ingredient (API) because of a heparin-like contaminant.
BioPharm Services (BPS, Chesham, UK) has appointed Miriam Monge vice president of Marketing and Disposables Systems Implementation.
In its effort to ensure that consistent definitions of terminology are being applied by all constituents of the ICH, the FDA has released a new guidance, E15, containing definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics.
Sinovac Biotech Ltd. (Beijing, China) has announced that Panflu, its pandemic influenza H5N1 whole viron inactivated vaccine, has been granted a production license by the China State Food and Drug Administration (SFDA).
The US FDA announced on April 4, 2008, the approval of Rotarix, the second oral US licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children.
Vincent J. Milano has succeeded Michel de Rosen as president and chief executive officer of ViroPharma Incorporated (Exton, PA) and has been elected to its board of directors, effective March 31, 2008.
GTC Biotherapeutics, Inc. (GTC, Framingham, MA) has entered into an extended agreement with PharmAthene, Inc. (Annapolis, MD) under which GTC will provide continuing process development and clinical supply manufacturing services for PharmAthene’s Protexia program.
Emerson Process Management (St. Louis, MO) has been chosen to automate the first Chinese plant to produce monoclonal antibody drugs.
PharmAthene, Inc., (Annapolis, MD), has completed its acquisition of Avecia’s (Manchester, UK) biodefense vaccines business.
Darren Head has been named chief executive officer of Cytovance (Oklahoma City, OK). Head comes to Cytovance from Atlanta-based Immucor where he served as vice-president of worldwide operations, overseeing the manufacturing of biological products in the US, Europe, and Canada.
Novozymes (Bagsvaerd, Denmark) has signed an exclusive worldwide licensing agreement for its albumin fusion technology, albufuse, with CSL Behring (King of Prussia, PA).
The FDA has identified the "heparin-like" contaminant in the API of Baxter's recalled heparin products to be over-sulfated chondroitin sulfate, a commonly available, cheap chemical compound.
The FDA is putting into effect a border alert for all heparin products manufactured by the Changzhou SPL plant, Baxter's supplier of heparin API. This alert would stop all heparin products produced by Changzhou SPL that are slated for entry into the US now and in the future.
