BioPharm International Editors

The US Food and Drug Administration (FDA, Rockville, MD) has proposed changes to pharmaceutical good manufacturing practices (GMPs).

Eden Biodesign, Ltd. (Liverpool, UK), has appointed Derek Ellison, PhD, vice president of development and manufacturing. Ellison, a co-founder of Eden, had previously held the title of business development director.

Sartorius Stedim Biotech has developed SARTOFLOW Alpha plus, a flexible modular benchtop crossflow filtration system, which provides semi-automatic micro-, ultra-, and diafiltration, and is especially suited for process development, clinical testing, and smaller production processes.

ImmunoVaccine Technologies, Inc. (IVT, Halifax, Nova Scotia), has successfully scaled up the manufacturing process for its vaccine platform, VacciMax.

The Society for Biological Engineering (SBE, New York, NY) has awarded the James E. Bailey Award to Professor George Georgiou, PhD, for his research and advancements in protein engineering and therapeutics.

Boehringer Ingelheim (BI, Ingelheim, Germany) has received FDA approval for the contract manufacture of an unnamed biological drug in glass prefilled syringes.

The International Federation of Red Cross and Red Crescent Societies (Geneva, Switzerland) and Eli Lilly and Company (Indianapolis, IN) have signed an agreement that will allow an eight-fold increase in the number of International Federation-supported programs to fight multidrug-resistant tuberculosis (MDR-TB) over the next four years.

An Israeli-based subsidiary of Modigene, Inc. (Vienna, VA) has received approval for a grant from the Israeli Office of the Chief Scientist (OCS) to support the company?s development of a long-acting version of human growth hormone (hGH), called hGH-CTP.

Fovea Pharmaceuticals SA (Paris, France) has entered into a collaborative research agreement with Genzyme Corporation (Cambridge, MA). The alliance is anchored around Fovea's proprietary high content technology platform that allows the identification of new targets involved in photoreceptor degeneration in retinal dystrophies.

The co-located Interphex China and API China exhibitions, held November 13–15 in Shenzhen-just across the river from Hong Kong-attracted 30,000 dealers, buyers, and sellers of ingredients, intermediates, excipients, and processing and packaging machinery.

Bristol-Myers Squibb (BMS, New York, NY) has announced plans to reduce its workforce by approximately 4,800 positions, more than 10% of its current workforce.

BioWa Inc., (Princeton, NJ) has entered into a second agreement with MedImmune to provide additional access to BioWa’s patented Potelligent technology platform for the development of antibody-dependent cellular cytotoxicity (ADCC) enhanced antibodies.

Eden Biodesign Ltd., (Liverpool, UK) has appointed Roger Lias, PhD, president of Eden Biodesign, US. Lias has extensive experience in the biotechnology industry with a specific emphasis on biomanufacturing services.

John Stageman, PhD, current vice president of AstraZeneca’s biopharmaceutical strategic planning, will assume the role of interim site head for the new MedImmune site in Cambridge, UK, after the name change from Cambridge Antibody Technology (CAT), announced on October 29, 2007.

A state-of-the-art biotechnology training center formally opened at North Carolina State University (NCSU, Raleigh, NC) on September 19, 2007.

John F. Carpenter, PhD, a member of BioPharm International’s editorial board, has been awarded the AAPS Research Achievement Award in Biotechnology.

Hospira (Lake Forest, IL) has received a "positive opinion" recommending European Union (EU) approval for its biosimilar Retacrit (epoetin zeta), a treatment for anemia associated with chronic renal failure and chemotherapy-induced anemia.

Genzyme Corporation (Cambridge, MA) and Sunway Biotech Company Limited (Shanghai, China) will collaborate to manufacture, develop, and commercialize the experimental gene therapy Ad2/HIF-1a in China.

Boston Analytics (Boston, MA) has released a report examining economic opportunities in the pharmaceutical market in India.

Bioengineering AG has developed a hygienic vacuum-breaking valve for the protection of large-scale sterile plants.

Novartis (Basel, Switzerland) officially opened a new pharmaceutical manufacturing site in Tuas, Singapore on October 29, 2007, adding capacity to its global production network to meet business growth and support new product launches in the US and Japanese markets.

Sanaria Inc., (Rockville, MD) and the PATH Malaria Vaccine Initiative have officially opened a clinical manufacturing facility to produce a vaccine that uses a weakened form of the malaria parasite to fight malaria, a disease that annually kills more than one million people.

Recent scientific advances and increased vaccine manufacturing capacity have prompted experts to increase their projections of how many pandemic influenza vaccine courses can be made available in the coming years.

Merck Serono (Geneva, Switzerland), a division of Merck KGaA, and Ecole Polytechnique Fédérale de Lausanne (EPFL, Lausanne, Switzerland) have entered into a research collaboration agreement in neuroscience, oncology, and drug delivery.

Xencor (Monrovia, CA) has appointed Jeffrey D. Bloss, MD, chief medical officer. Bloss will direct Xencor's clinical and preclinical development strategies.

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