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
As part of a news series on the H1N1 influenza pandemic, BioPharm International interviewed Ben Machielse, Drs., executive vice president of operations at MedImmune, to ask about his company's experience manufacturing vaccines against H1N1.
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.
In February, we reported on Pfizer's plans for reconfiguring its global manufacturing network of 79 plants, following its recent acquisition of Wyeth. Now, we have the answer.
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.
