News

Genzyme and Sanofi cut jobs.

President's Council and HHS Call for Overhaul of Pandemic Response Programs

Lonza Expands Service Platform to Viral Vaccines, Gene Therapy Vectors

Medicago Awarded $21 million from the US Department of Defense

Regulators, Industry Disagree Over Noncritical Process Parameters at CMC Forum

Nabi Receives Key Patent for Nicotine Vaccines, Enters Manufacturing Agreement with Diosynth

Temasek Life Science Ventures Pte, Ltd. (TLV, Singapore) and Emergent BioSolutions Inc. (Rockville, MD) will form EPIC BIO Pte Ltd, a joint venture to develop, manufacture, and commercialize a multivalent, cross-protective human vaccine to protect against influenza caused by a broad range of circulating H5 influenza strains.

RecipharmCobra Biologics Receives Patent for Antibiotic-Free Plasmid Maintenance System

ISCT Joins Forces with Roche and Genzyme to Launch Cell Therapy Industry Partnership

The Maryland Technology Enterprise Institute (Mtech, College Park, MD) Bioprocess Scale-Up Facility (BSF) will double its facilities and staff, expand into Shady Grove, acquire new equipment, and create a pilot plant for biofuels in College Park through the support of a $200,000 shared resource grant from the Maryland Biotechnology Center (MBC).

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.