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ATMI, Inc. has acquired the Belgian biotechnology firm Artelis SA, which offers technologies for cell culture research and manufacturing scale-up.

In a speech on October 6, 2010, FDA Commissioner Margaret Hamburg outlined the FDA's plan for advancing regulatory science. Her address introduced an FDA document, Advancing Regulatory Science for Public Health, which was released concurrent to her talk.

The US Department of Health and Human Services? (HHS) Biomedical Advanced Research and Development Authority (BARDA) is providing three sets of grants totaling $10.4 million to help the World Health Organization (WHO) strengthen developing countries? ability to produce flu vaccines, potentially reducing the global threat from influenza.

Laureate Pharma, Inc. (Princeton, NJ) has secured $20 million in debt and equity financing to grow its business. The new funds will be used to expand existing capacity in protein production and aseptic filling and to expand its service offerings in analytical testing and cell line development.

On September 21, 2010, Gilead Sciences (San Dimas, CA) received a warning letter from the US Food and Drug Administration, citing violations of current good manufacturing practices (cGMP) for its manufacturing and quality processes related to the production of antifungal agent AmBisome at its California facility.

US Health and Human Services Secretary Kathleen Sebelius has predicted that a cell-based seasonal flu vaccine could be on the market by the 2011?2012 flu season, as reported by CIDRAP of the University of Minnesota.

ARTES Biotechnology (Langenfield, Germany) has acquired the Anavax virus-like particle (VLP) technology from Select Vaccines Ltd. (Melbourne, Australia). Anavax is a patent-protected VLP technology that can be applied to develop vaccines for the prevention of several infectious diseases.

IDT Biologika, GmbH (Dessau-Rosslau, Germany), a contract manufacturer of vaccines and biopharmaceuticals, will expand its viral vaccine production capacity with the addition of a new high-speed filling line and additional lyophilization capacity. The company also will add 80 employees to its workforce?an increase of approximately 11%?to meet growth in demand for its biologics production.

SP Scientific (Gardiner, NY) has signed a license agreement to use Praxair's (Danbury, CT) ControLyo nucleation-on-demand technology, which provides pharmaceutical and biotechnology companies with control over the freeze-drying process for drug developmental efforts.

Amgen has issued Epogen and Procrit recall.

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

Genzyme Corporation (Cambridge, MA) has reported that production of its Gaucher treatment, Cerezyme is now up to historical averages and they began increasing shipments in August.

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.