BioPharm International Editors

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.

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

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.

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.

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.

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.

Profectus BioSciences, Inc. (Baltimore, MD), a clinical stage biopharmaceutical company focused on the development of novel vaccine candidates for serious chronic infections, has signed a research collaboration agreement with the PATH Malaria Vaccine Initiative (Bethesda, MD) to conduct proof-of-concept studies with its proprietary, recombinant vesicular stomatitis virus (rVSV) vector technology as a preventative malaria vaccine.

GlaxoSmithKline has partnered with Brazil?s Oswaldo Cruz Foundation (Fiocruz) to develop and manufacture vaccines for pressing public health problems in Brazil.

Protalix BioTherapeutics received "fast track" designation from the US FDA yesterday for prGCD, a development drug for Gaucher's disease.

A new vaccine for norovirus has been produced in tobacco plants, a scientist reported on August 18 at the national meeting of the American Chemical Society in Washington DC.

Amgen (Thousand Oaks, CA) and GlaxoSmithKline (GSK, London, UK) will share commercialization of Amgen's monoclonal antibody denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand, and Mexico once the product is approved in these countries.

FDA Acting Commissioner Margaret Hamburg outlined six steps to improve FDA enforcement in a speech given on August 6, eight weeks into her tenure.

Baxter International, Inc. has completed production of its first commercial batches of Celvapan A/H1N1 pandemic vaccine in late July and is discussing plans for distribution with national health authorities, subject to obtaining appropriate authorizations.

Millipore Corporation (Billerica, MA) has filed a lawsuit in the US District Court for the District of Massachusetts against W.L. Gore & Associates for infringement of Millipore's patent rights under US Patent No. 7,293,477, "Disposable, Pre-Sterilized Fluid Receptacle Sampling Device."

Preliminary evidence has shown that ImmuneRegen BioSciences' selective Neurokinin 1-receptor agonist Homspera is active on oral administration and provides therapeutic effects against the current pandemic H1N1 virus infection.

ImmunoVaccine Technologies, Inc. (IVT) has formed a research agreement with Scancell, Ltd. to explore the potential of using IVT's DepoVax delivery system for Scancell's ImmunoBody DNA vaccines.

Debiopharm Group (Lausanne, Switzerland) and MSM Protein Technologies (MSM, Boston, MA) have entered into an exclusive agreement for the development and commercialization of Debio 0929, an antibody targeting a G protein-coupled receptor (GPCR), to be developed into a new oncology therapeutic drug.

The US FDA has approved Genentech's Avastin (bevacizumab) plus interferon-alfa for people with metastatic renal cell carcinoma, the most common type of kidney cancer.

Wyeth has voluntarily recalled one lot of single-dose prefilled syringes of Prevnar, the company?s pneumococcal 7-valent conjugate vaccine.