BioPharm News

May 08, 2008
BioPharm International
By BioPharm International Editors
On April 9, 2008, Genzyme Corporation (Framingham, MA) announced a recall of three lots of its organ-rejection antibody, Thymoglobulin, because of stability concerns.
May 08, 2008
BioPharm International
By BioPharm International Editors
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).”
May 08, 2008
BioPharm International
By BioPharm International Editors
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.
May 08, 2008
BioPharm International
By BioPharm International Editors
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.
May 08, 2008
BioPharm International
By BioPharm International Editors
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)].
May 08, 2008
BioPharm International
By BioPharm International Editors
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.
May 08, 2008
BioPharm International
By BioPharm International Editors
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).
Apr 30, 2008
By BioPharm International Editors
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.
Apr 22, 2008
By BioPharm International Editors
The contamination of heparin is far more widespread, and began earlier, than first believed, FDA officials announced on April 21, 2008.
Apr 11, 2008
By BioPharm International Editors
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.
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