Patricia Van Arnum was executive editor of Pharmaceutical Technology.
FDA Approves Sandoz's Omnitrope as Follow-on Protein Product
June 2nd 2006Sandoz (Holzkirchen, Germany), the generics arm of Novartis (Basel, Switzerland), received approval from the US Food and Drug Administration (Rockville, MD) for "Omnitrope" (somatropin [rDNA origin]), a follow-on version of a previously approved recombinant human growth hormone (rhGH) product.
China Seeks to Strengthen Regulatory Supervision of Drug Manufacturers
June 2nd 2006China?s State Food and Drug Administration (SFDA, Beijing, China) issued a notice on May 18, 2006, requiring drug regulatory departments of provinces, autonomous regions, and municipalities to further strengthen the supervision and management of drug manufacturers.
National Science Foundation Awards Multimillion Grant in Pharmaceutical Manufacturing
May 25th 2006Rutgers, the state university of New Jersey (New Brunswick, NJ), the New Jersey Institute of Technology (Newark, NJ), Purdue University (West Lafayette, IN), and the University of Puerto Rico (Mayag?ez, PR) won a $15-million, five-year grant from the National Science Foundation (Arlington, VA) to improve the manufacturing of pharmaceuticals, food, and agricultural products.
Merck To Acquire Biologics Companies GlycoFi and Abmaxis
May 11th 2006Merck & Co Inc. (Whitehouse Station, NJ) has agreed to acquire two biologics companies: GlycoFi Inc. (Lebanon, NH), a specialist in yeast glycoengineering for $400 million, and the biopharmaceutical company Abmaxis Inc. (Santa Clara, CA) for $80 million.
Clariant Divests Pharmaceutical Fine Chemicals Business
May 4th 2006Clariant (Muttenz, Switzerland) has agreed to sell its pharmaceutical fine chemicals unit to the private equity firm TowerBrook Capital Partners LP (New York, NY) for CHF 110 million ($89 million). The price includes an earn-out participation of CHF 40 million ($32 million) to be paid in two years.
Discovery Laboratories Reports on Surfaxin Manufacturing Issues
April 27th 2006The biotechnology company Discovery Laboratories Inc. (Warrington, PA, www.discoverylabs.com) reports that analysis of ongoing stability data from "Surfaxin" process validation batches indicates that certain stability parameters have not been achieved, and additional process validation batches will likely have to be produced.
Sandoz Wins EU Approval, US Progress for Biogeneric Product
April 20th 2006Sandoz (Holzkirchen, Germany), the generics division of Novartis (Basel, Switzerland) received European marketing authorization for its recombinant human growth hormone, ?Omnitrope? (somatropin), making it the first biogeneric product approved under the biosimilar pathway of the European Commission.
Biosciences Employment and Earning Power Increases
April 13th 2006Total employment in the biosciences in the United States reached 1.2 million in 2004, the latest year for which data are currently available, according to the study, "Growing the Nation's Bioscience Sector: State Bioscience Initiatives 2006," which was released this week at BIO 2006