All News

Crucell N.V. (Leiden, the Netherlands) has signed an exclusive collaboration and commercialization agreement with Sanofi Pasteur (Lyon, France) for Crucell’s rabies monoclonal antibodies, the next-generation rabies biologicals to be used in association with rabies vaccine for post-exposure prophylaxis against this fatal disease.

Merck Serono (Geneva, Switzerland), a division of Merck KGaA, will collaborate with Flamel Technologies (Lyon, France) to investigate the applicability of Flamel’s Medusa technology for the extended release of a therapeutic protein in Merck Serono’s portfolio.

Nektar Therapeutics (San Carlos, CA) will work with subsidiaries of Baxter International, Inc. (Deerfield, IL), to develop new PEGylated therapeutics for hemophilia.

Apitope Technology Ltd. (Bristol, UK), has announced the completion of dosing for all six multiple sclerosis (MS) patients in a Phase 1/2a trial of ATX-MS-1467

AM2 PAT, Inc., (Angier, NC) has initiated a nationwide recall of one lot of prefilled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H.

On December 26, 2007, President Bush signed into law H.R. 2764, which gives the FDA nearly $1.73 billion in funding for fiscal 2008.

The FDA has announced that it is seeking a director for the Center for Drug Evaluation and Research (CDER).

International Society for Pharmaceutical Engineering (ISPE, Tampa, FL), a global not-for-profit association of 25,000 pharmaceutical science and manufacturing professionals, has announced its 2007 award winners.

Nashville–based GenHunter Corporation has been granted a US patent (7,268,116) for a new protein expression technology.

Maxygen, Inc. (Redwood City, CA), has announced the licensing of its proprietary dengue virus antigen technology to Sanofi Pasteur (Lyon, France).

MorphoSys AG (Munich, Germany) and Novartis (East Hanover, NJ) have formed a comprehensive strategic alliance for the discovery and development of biopharmaceuticals.

Under a new agreement with ProGenetics LLC (Blacksburg, VA), GTC Biotherapeutics (GTC, Framingham, MA) will expand its portfolio to include protein therapeutics produced in the milk of transgenic pigs.

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.