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Shire has gained European approval for its gaucher disease treatment

ImClone, a subsidiary of Eli Lilly, has closed a manufacturing facility at its site in Branchburg, NJ, as originally reported by MyCentralJersey.com and confirmed by BioPharm International.

EMa and FDA are seeking potential candidate companies for a joint GMP inspection pilot program.

The UK?s Engineering and Physical Sciences Research Council (EPSRC) has awarded a Knowledge Transfer Secondment grant to BioPharm Services (Chesham, UK) and University College London?s Innovative Manufacturing Research Centre (IMRC) for Bioprocessing.

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).

ATMI Inc. has established a North American hub for the production, marketing, and development of its single-use technologies for biopharmaceutical and other life sciences applications by expanding its Bloomington, MN manufacturing facility.

Human Genome Sciences (HGS, Rockville, MD) has selected Lonza (Basel, Switzerland) as its contract manufacturer for the future commercial supply of Benlysta.

Genzyme has signed a new supply agreement with Hospira Inc

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).

After 18 years, Human Genome Sciences (HGS, Rockville, MD) may soon have its first drug on the market. And thanks to a bold scale-up strategy, HGS?s manufacturing organization is ready.

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.

Celgene to Acquire Abraxis

FDA approves Genentech's Lucentis

Vetter held a groundbreaking ceremony for its new facility in Ravensburg.

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