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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.

When CDER director Steven Galson left last year, Janet Woodcock shifted back as temporary chief. And now, after a long search for a replacement, she has decided to take on the job herself.

According to a report released by the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO), the three most common types of influenza strains have changed in such a way that they are now showing signs of resistance to the Tamiflu and Relenza vaccines

The US Pharmacopeia (USP) held an official grand opening celebration on March 3, 2008, for its new global headquarters in Rockville, MD.

“We need to improve our ability to measure protein variants in real time and understand how to correlate to biological significance,” commented Duncan Low, PhD, scientific executive director at Amgen, in a January 28 presentation at the IFPAC 2008 meeting in Baltimore, Maryland.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, has announced that the reorganization of the Office of Surveillance and Epidemiology (OSE) has been completed.

Franz B. Humer has stepped down as chief executive officer (CEO) of the Roche Group (Basel, Switzerland), after holding that title for 10 years.