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Bayer Acquires Biologics Manufacturing Facility, Rights from Novartis

October 9, 2007

Bayer Schering Pharma AG, (Berlin, Germany) has completed the acquisition of a biologics manufacturing facility in Emeryville, CA, from Novartis.

Bristol-Myers Squibb to Acquire Adnexus Therapeutics

October 9, 2007

Bristol-Myers Squibb (Princeton, NJ) will acquire privately held Adnexus Therapeutics (Waltham, MA), the developer of a new therapeutic class of biologics called Adnectins.

PAREXEL Appoints Three New GMP Consultants for Europe

October 9, 2007

PAREXEL Consulting (Boston, MA) has hired three senior GMP consultants based in Europe with the hope of helping its clients address complexities of European Union directives in areas such as manufacturing regulations, quality, and safety.

Discovery Labs Sorts Out Manufacturing Issues, on Track for FDA Approval Letter

October 9, 2007

Discovery Laboratories (Warrington, PA) could see the end of its struggle to launch its Surfaxin (lucinactant) drug on the US market soon, as the manufacturing issues it has faced have been resolved.

On the Biotechnology Frontier: Personalized Medicine, A Discussion with E.J. Brandreth

October 1, 2007

Favrille, a San Diego-based biopharmaceutical company, is one of a handful of firms on the forefront of personalized medicine. Because personalized treatment is tailored to an individual's biology, it has the potential to be far more effective than current approaches to disease management.

Final Word: In the Quest to Manage Capacity, Biology Trumps Stainless Steel

September 1, 2007

From the earliest days of the biotechnology industry, companies have grappled with the complexities of making innovative biopharmaceuticals on a large scale. Success in manufacturing begins with process science, since biotech production requires perfection in maintaining living organisms in a sterile environment under controlled physiological conditions. But unless companies can solve the challenge of planning for and managing manufacturing capacity, they will not be able to achieve the full potential of promising biotech products.

Final Word: The Case for Flexible Manufacturing Capacity

August 1, 2007

The mounting threats of pandemic influenza, bioterrorism, and emerging infectious diseases continue to be the focus of research programs and funding initiatives, not only within governmental agencies, but also universities, private research firms, and commercial manufacturing entities. With all of these efforts, however, the question of manufacturing capacity and the ability to respond to pandemic and emerging threats continues to be a major concern.

Expanded FluMist Indication Delayed by cGMP Violations

June 21, 2007

The FDA issued MedImmune, Inc. (Gaithersburg, MD, www.medimmune.com), a warning letter for violating the agency's manufacturing rules and held off approving the company's influenza vaccine for use in children younger than age five until the problems are resolved.

Roche Opens New Biotechnology Production Center in Switzerland

June 21, 2007

Roche (Basel, Switzerland, www.roche.com) has opened its new biotechnology production center in Basel.

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