BioPharm International Editors

The US Food and Drug Administration has approved vaccines for the 2010?2011 influenza season in the United States.

ProtAffin AG (Graz, Austria), a biotechnology company developing a class of biopharmaceutical products that act by targeting cell-surface glycan structures, has signed a manufacturing contract with CMC Biologics? Danish operations (Copenhagen, Denmark), for manufacturing its lead product PA401 for the treatment of chronic obstructive pulmonary disease (COPD).

On July 22, 2010, Sanofi Pasteur (Lyon, France) received a warning letter from the US Food and Drug Administration, citing deviations from current good manufacturing practices (cGMPs) in the manufacture of certain biological products and bulk drug substances, including Imovax Rabies, Imogam Rabies, Ipol, Act HIB, and Typhim Vi.

The US Food and Drug Administration has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor manufactured by Amgen (Thousand Oaks, CA), for the treatment of bone metastases to reduce skeletal-related events (SREs) in patients with cancer.

The Department of Health and Human Services (HHS), through the Biomedical Advanced Research and Development Authority (BARDA), has awarded Pfenex, Inc. (San Diego, CA) a contract to support the development of a robust Pfenex expression technology-based production strain and process for the production of bulk recombinant protective antigen (rPA) from anthrax.

The US Food and Drug Administration has designated XOMA 052, an antibody to interleukin-1 beta manufactured by XOMA, Ltd. (Berkley, CA), an orphan drug for the treatment of Behcet's disease.

Watson Pharmaceuticals, Inc. (Morristown, NJ) has signed an exclusive, worldwide licensing agreement with Itero Biopharmaceuticals, Inc. (San Mateo, CA), a venture-backed specialty biopharmaceutical company, to develop and commercialize Itero's recombinant follicle stimulating hormone (rFSH).

Astellas Pharma, Inc. (Tokyo, Japan) has extended its non-exclusive license agreement with Regeneron Pharmaceuticals, Inc. (Tarrytown, NY) through 2023. The agreement allows Astellas to use Regeneron?s VelocImmune technology in Astellas? internal research programs to discover fully human monoclonal antibody (hMAb) product candidates.

Novavax, Inc. (Rockville, MD) has been issued US Patent No. 7,763,450 for Functional Influenza Virus-Like Particles (VLPs).

Following the news that the current supply of Genzyme's (Cambridge, MA) Fabrazyme (agalsidase beta) will not be sufficient to address the needs of the nearly 600 Fabry patients receiving the treatment in Europe, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the use of alternate Fabry treatments, such as Replagal, manufactured by Shire (Dublin, Ireland).

Merck (Whitehouse Station, NJ) expects that emerging markets will account for more than 25% of its global pharmaceutical and vaccine revenue in 2013, based on the implementation of the company?s emerging markets strategy.

ATMI, Inc. (Danbury, CT), and Sartorius Stedim Biotech S.A. (Aubagne, France) have extended their marketing and distribution alliance by adding new technologies.

Intercell AG's (Vienna, Austria) investigational vaccine enhancement patch (VEP) system for avian H5N1 influenza has failed its Phase 2 clinical trial.

Crucell N.V. (Leiden, the Netherlands) has begun a discovery program for the development and commercialization of a universal respiratory syncytial virus (RSV) vaccine.

MorphoSys, AG (Munich, Germany) and biopharmaceutical company Xencor, Inc. (Monrovia, CA) have signed a worldwide exclusive license and collaboration agreement for an antibody in Phase 1 clinical development.

New Brunswick Scientific, an Eppendorf Company (Edison, NJ), and Pall Corporation (Port Washington, NY) have entered into a product development and marketing agreement to create and supply new disposable bioreactor systems.

The US Food and Drug Administration has issued a new draft guidance regarding the types of manufacturing changes that can be reported in annual reports.

FDA approves Genentech's Lucentis

US Food and Drug Administration has granted fast track status to Cambridge, MA-based Genzyme Corporationhas been granted fast track status by the FDA for its alemtuzumab for multiple sclerosis (MS) development program.

BiondVax Awarded $1 Million Universal Flu Vaccine Grant from Israeli Office of the Chief Scientist

CPL Biologicals, a joint venture of Cadila Pharmaceuticals Ltd. (Ahmendabad, India) and Novavax, Inc. (Rockville, MD), has completed construction of its vaccine facility in Dholka, India.

Baxter BioScience (Deerfield, IL) and the US Food and Drug Administration have notified healthcare professionals of a market withdrawal being conducted as a precautionary measure because of an increased number of adverse event reports of allergic reactions associated with two lots of GammaGard Liquid.

Abbott (Abbott Park, IL) will acquire full ownership of Piramal Healthcare Limited?s Healthcare Solutions business (Mumbai, India), a provider of Indian-branded generics, for an up front payment of $2.12 billion, plus $400 million annually for the next four years.

Shimadzu (Kyoto, Japan) and bioMérieux (Marcy l?Etoile, France) will commercialize a mass spectrometry system for bacterial identification in microbiology laboratories.

The US Food and Drug Administration has cleared the Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 influenza virus in patients with signs and symptoms of respiratory infection.

Covidien (Dublin, Ireland), a provider of healthcare products, will sell its Specialty Chemicals business, known in the industry as two brand names, J.T.Baker and Mallinckrodt Laboratory Chemicals to an affiliate of New Mountain Capital, L.L.C. for $280 million.

Teva Pharmaceutical Industries (Tikva, Israel) is developing a generic version of Roche's (Basel, Switzerland) blockbuster antibody drug Rituxan, in what may possibly be the first US generic version of a monoclonal antibody.

A first-of-its-kind vaccine to prevent breast cancer has shown favorable results in animal models, according to a study by researchers at Cleveland Clinic?s Lerner Research Institute (Cleveland, OH).

The US Food and Drug Administration has approved Prolia (denosumab), manufactured by Amgen Inc. (Thousand Oaks, CA), for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Thomson Reuters' Mark Gordon looks at how real partnership opportunities are developing in a virtual pharma world.