News

A jury in the US Federal District Court in Boston ruled on October 23, 2007, that Roche's pegylated-erythropoietin (peg-EPO) product, Mircera, infringes 11 Amgen EPO patent claims.

The US Food and Drug Administration (FDA) has expanded the approved age range for Menactra, a bacterial meningitis vaccine, to include children ages 2 to 10 years.

Scott Monroe, MD, has accepted the position of director of the Division of Reproductive and Urologic Products (DRUP) at the US Food and Drug Administration.

Dynavax Technologies Corporation (Berkeley, CA) and Merck & Co., Inc. (Whitehouse Station, NJ) have announced a global license and development collaboration agreement to jointly develop HEPLISAV, an investigational hepatitis B vaccine that is currently being evaluated in a multi-center Phase 3 clinical trial involving adults and in patients on dialysis.

The upcoming Quality by Design (QbD) pilot program for biotech filings will focus on comparability protocols, Helen Winkle, director of the Office of Pharmaceutical Science at the FDA's Center for Drug Evaluation and Research, said on September 20, 2007.

The approval of a new seasonal influenza vaccine has further diversified the supply to the US market.

Isis Pharmaceuticals, Inc. (Carlsbad, CA), has purchased Symphony GenIsis for $120 million.

The US Food and Drug Administration has approved the use of the nasal influenza vaccine FluMist in children ages 2?5.

Cobra Biomanufacturing is an international full-service manufacturer of biopharmaceuticals, dedicated to designing robust processes that deliver biopharmaceutical products to its life sciences customers for preclinical through Phase 3 studies.

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.

Acambis plc (Cambridge, UK) has appointed Elizabeth Jones chief financial officer (CFO) and an executive director of the board.

Sanofi Pasteur (Lyon, France) has announced positive results from Phase 2 trials of its dengue vaccine candidate based on technology licensed from Acambis plc (Cambridge, UK).

Crucell N.V. (Leiden, the Netherlands) has discovered a set of human monoclonal antibodies (MAbs) that work to neutralize and protect against H5N1.

Wyeth (Madison, NJ) has elected Bernard Poussot president and chief executive officer (CEO), effective January 1, 2008.

Sanofi Pasteur (Lyon, France) has produced data showing that its new investigational H5N1 pandemic influenza vaccine containing a proprietary adjuvant achieved a high immune response at the lowest dose of H5N1 antigen reported to date.

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.

SAFC (St. Louis, MO), a member of the Sigma-Aldrich Group, has announced a $29-million investment to significantly expand its drug substance capabilities in high-potency biologics at the Sigma-Aldrich facility in Jerusalem, Israel

The US Patent & Trademark Office has issued the fifth US patent to MorphoSys AG (Munich, Germany) stemming from MorphoSys’s base HuCAL (human combinatorial antibody library) patent family, providing extended protection to MorphoSys’s core technology.

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

Idenix Pharmaceuticals, Inc. (Cambridge, MA), has announced a strategic restructuring and an amended collaboration agreement with Novartis Pharma AG related to Sebivo (also marketed as Tyzeka), an oral treatment for patients with chronic hepatitis B.

Five European organizations, including three companies and two hospitals, have joined forces to develop a novel pandemic influenza vaccine as a potential emergency vaccination.

Steven Galson, MD, has been appointed acting surgeon general beginning October 1, 2007.

Sandoz (Holzkirchen, Germany), a division of the Swiss pharmaceutical company Novartis, has become the first company to receive European Commission approval for a biosimilar of epoetin alpha.

Cees de Jong will take the position of Chief Operating Officer at Crucell N.V. (Leiden, The Netherlands, cws.huginonline.com).

The BIOSTAT Cultibag RM is a disposable bioreactor that combines rocking motion mixing technology with Sartorius engineered control capabilities.

Jerzy Gruhn has been appointed president of the US affiliate of Novo Nordisk Inc., (Princeton, NJ, www.novonordisk.com), and senior vice president of Novo Nordisk North America.

Small biotechnology companies often need guidance during the development of new therapies-particularly when it comes to manufacturing.

PDL BioPharma (Fremont, CA), has announced that three-month internal investigation of the company's chief executive officer (CEO), Mark McDade, found no credible evidence to substantiate the allegations made by shareholders.