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FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus

Morphotek, Inc. (Exton, PA), a subsidiary of Eisai, Inc., has entered into a license agreement with Centocor Ortho Biotech, Inc. (Horsham, PA), for the development and commercialization of an antibody that targets a tumor-associated antigen over-expressed in many solid tumors.

SAIC-Frederick, Inc. (Frederick, MD), has signed a contract with GenVec, Inc. (Gaithersburg, MD), for the development of influenza and HIV vaccines in support of the Vaccine Research Center (VRC, Frederick, MD).

Octapharma Group (Bad Homburg, Germany) and Fresenius Kabi (Lachen, Switzerland) have signed a license, development, and supply agreement for the use of Fresenius Kabi's HESylation technology to develop a HESylated recombinant protein.

The US Food and Drug Administration has granted priority review for Shire plc's (Cambridge, MA) New Drug Application (NDA) for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease.

Brain drug delivery company to-BBB, (Leiden, The Netherlands) has entered into a research collaboration with Genzyme Corporation (Cambridge, MA) to evaluate to-BBB?s proprietary G-Technology to enhance delivery of biologics for neurodegenerative diseases.

In an attempt to save around $60 million annually, the Danish biopharmaceutical company Genmab is planning to sell its manufacturing facility located in Brooklyn Park, MN, and reduce headcount by approximately 300 positions.

The US Food and Drug Administration has granted orphan drug designation to GenVec, Inc.'s TNFerade for the treatment of pancreatic cancer.

In a ribbon-cutting ceremony held on October 30, 2009, Sartorius (Goettingen, Germany) inaugurated its new plant at the Sartorius Group's location in Bangalore, India.

CPL Biologicals Pvt. Ltd. has begun construction of a state-of-the-art manufacturing facility in India that will be used to produce pandemic and seasonal influenza vaccines.

In keeping with the growing trend of iPhone applications for every conceivable convenience, DASGIP AG (Juelich, Germany), a provider of parallel bioreactor systems at benchtop scale, has launched an iPhone application for accessing bioprocesses online.

SAFC Pharma has announced the completion of an addition to its Carlsbad, CA, facility, which specializes in the process development and manufacturing of viral vaccines and viral therapeutics.

The Korean CMO Celltrion and Hospira, a small-molecule injectable generics and drug delivery company based in Lake Forest, IL, agree to co-market biosimilars developed by Celltrion.

The US Food and Drug Administration?s Vaccines and Related Biological Products Advisory Committee voted that clinical data support both the efficacy and safety of Cervarix, GlaxoSmithKline?s (GSK, Middlesex, UK) candidate cervical cancer vaccine.

Neoprobe Corporation (Dublin, OH) and Laureate Pharma, Inc. (Princeton, NJ) have entered into a Biopharmaceutical Development and Manufacturing Agreement.

The US Food and Drug Administration today approved Stelara (ustekinumab), a biologic manufactured by Centocor Ortho Biotech, Inc. (Horsham, PA),for adults who have a moderate to severe form of psoriasis.

Diminutive bacteria with the right geometry (i.e. very thin) may be useful for research and development work on sterilizing-grade and other 0.2 uM filters, said Kurt Brorson, PhD, a staff scientist for the FDA/CDER's Division of Monoclonal Antibodies.

New heparin standards recently adopted by the United States Pharmacopeia (USP) include new tests to ensure the quality of the drug.

Baxter International Inc. (Deerfield, IL) has been granted marketing authorization for Celvapan H1N1 pandemic vaccine using Baxter's Vero cell technology by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).

Florida Biologix (Alachua, FL) has signed a development and manufacturing contract with America Stem Cell (Helotes, TX) for a Phase 1 cell therapy product, ASC-101. ASC-101 is a human recombinant enzyme technology that increases the efficiency of engraftment in transplantation of cord blood derived stem cells.

Colorado-based InVitria, a division of the biopharmaceutical company Ventria Bioscience, has launched an animal-free recombinant transferrin for use in mammalian cell culture.

The US Food and Drug Administration announced yesterday that it has approved four vaccines against the 2009(A)H1N1 (?swine?) influenza virus.

Lonza (Basel, Switzerland), broke ground earlier this week on a new cell therapy manufacturing facility in Tuas Biomedical Park, Singapore, adjacent to Lonza?s large-scale mammalian manufacturing facility.

Protalix BioTherapeutics, Inc. (Carmiel, Israel) gained orphan drug status from the US FDA for prGCD, a development drug for Gaucher?s disease, on September 9. The orphan drug designation for prGCD was granted by the FDA?s Office of Orphan Products Development and comes less than a month after the drug received fast-track designation from the FDA.

Sales of the Top 10 biotech drugs exceeded $41.5 billion in 2008, according to a new report issued by BioWorld Today.

To assess current trends in cleanrooms and engineering & facilities, BioPharm International turned to Parrish Galliher, founder and chief technology officer, Xcellerex, Inc.; Jim Maslowski, owner, PDC Aseptic Filling Systems; Morgan Polen, vice president, application technology, Lighthouse Worldwide Solutions; and Benoît Verjans, commercial director, Aseptic Technologies.

The European Commission has granted marketing authorization for Genzyme Corporation?s (Cambridge, MA) Mozobil (plerixafor injection) for patients with the blood cancers lymphoma and multiple myelomawho require an autologous stem cell transplant.

CatalentPharma Solutions (Somerset, NJ) has created a business unit dedicated to helping customers bring new pharmaceutical and biologic products to market.