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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.

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.

Shire plc (Cambridge, MA) has completed its submission of a new drug application (NDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease, with the US Food and Drug Administration.

Novavax (Rockville, MD) recently achieved positive Phase 2a results for its trivalent virus-like particle (VLP) vaccine against seasonal influenza, and positive preclinical results for a VLP vaccine against H1NI (swine) flu.

Pharmaceutical giant Pfizer, Inc., (New York, NY) has opened a new 64,600-square-foot biotech plant in Strangnas, Sweden.

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.

London-based GlaxoSmithKline?s Hiberix, a haemophilus influenzae Type b (Hib) vaccine, was approved by the US Food and Drug Administration.

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.

Protalix BioTherapeutics received approval from the US FDA on August 17 to proceed with its treatment protocol for prGCD, a development drug for Gaucher's disease.

SAFC Biosciences (St. Louis, MO) has developed a chemically defined cell culture supplement based on the characterization of hydrolysate components proven to provide cell growth and protein production capabilities equivalent to traditional undefined hydrolysate raw materials.

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.

The prospect of conducting risk assessments, as part of the quality risk management strategy promoted by the International Conference on Harmonization (ICH) Q9 guideline, tends to evoke blank stares and confusion. It also prompts many questions: Which of the many tools-PHA, HACCP, FMEA, etc.-should we use?

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.