BioPharm International Editors

Workshops Based on the A-MAb Case Study

TenX Biopharma, Inc. (Philadelphia, PA) has signed a licensing agreement to acquire exclusive worldwide rights to develop and commercialize zanolimumab (HuMax-CD4) from Genmab A/S (Copenhagen, Denmark).

GlaxoSmithKline (GSK, London, UK) has begun a series of initiatives, which aim at combating diseases that affect the world?s poorest countries.

Repligen Corporation (Waltham, MA) has extended its longstanding relationship with GE Healthcare Bio-Sciences AB by entering into a five-year supply agreement for recombinant Protein A, a consumable used in the manufacture of monoclonal antibodies (MAbs).

SciClone Pharmaceuticals, Inc. (Foster City, CA) and its partner Sigma-Tau, S.p.A. (Rome, Italy) have received initial topline results in a clinical study evaluating the potential of Zadaxin (thymalfasin) to enhance immune response to the MF59 adjuvanted H1N1 influenza monovalent vaccine, Focetria, from Novartis (Basel, Switzerland).

The US Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the President's fiscal year 2011 budget?a 23% increase over the agency?s current $3.28 billion budget.

The US Food and Drug Administration has approved Sanofi Pasteur's Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older, to prevent disease caused by influenza virus subtypes A and B.

Shire plc (Cambridge, MA) has submitted a biologics license application (BLA) with the FDA for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease.

The US Food and Drug Administration has approved Genentech's Actemra (tocilizumab) to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved therapies for rheumatoid arthritis.

BiondVax Pharmaceuticals Ltd, an Israeli biopharmaceutical company, has completed Phase 1-2 clinical trials of its Multimeric-001 universal flu vaccine.

Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, has signed an agreement with KaloBios Pharmaceuticals for the development of humanized antibody fragment to both treat and prevent Pseudomonas aeruginosa infections.

MedImmune, a division of AstraZeneca (London, UK), yesterday recalled 13 lots (4.7 million doses) of its nasal spray H1N1 (swine) flu vaccine, because of a drop in potency.

Merck & Co. Inc., (Whitehouse Station, NJ) has announced plans to buy the biologics business of the Avecia group (Tees Valley, UK), through a Merck affiliate (Merck Sharp & Dohme, MSD).

GlaxoSmithKline Biologicals SA (GSK, London, UK) and Intercell (Vienna, Austria) have formed a strategic alliance to accelerate the development and commercialization of needle-free, patch-based vaccines.

Artes Biotechnology (Langenfeld, Germany) and Rhein Minapharm Biogenetics (Cairo, Egypt) have produced a new target of a therapeutic protein.

Novo Nordisk has initiated its first Phase 1 clinical trial with an oral insulin analog, NN1952, which was created using Merrion Pharmaceuticals' GIPET technology.

Gyros AB (Uppsala, Sweden), a provider of automated micro-immunoassays for therapeutic protein development, has signed a distribution agreement with DI Biotech (Seoul, Korea), a supplier to the Korean life sciences market.

A ground breaking ceremony for the commencement of construction of the National Institute for Bioprocessing Research and Training (NIBRT) at Belfield Innovation Park in Dublin was held on November 29.

Sinovac Biotech Ltd. (Beijing, China), a developer and provider of vaccines, has executed a joint venture agreement to establish Sinovac (Dalian) Vaccine Technology Co., Ltd. (Sinovac Dalian).

Genzyme Corporation (Cambridge, MA) has begun shipping vials of newly produced Cerezyme (imiglucerase for injection) manufactured at its plant in Allston Landing, MA.

The FDA and Genzyme have notified healthcare professionals about the potential for foreign particle contamination of several Genzyme products: Cerezyme, Fabrazyme, Myozyme, and Thyrogen, which are supplied as lyophilized powders requiring reconstitution before administration; and Aldurazyme, which is supplied as a liquid solution. The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process, and could potentially cause serious adverse events in patients.

Abraxis Biosciences, a Los Angeles-based biotechnology company, unveiled a $70-million biopharmaceutical manufacturing plant in Phoenix, to serve as the company's manufacturing site for its pipeline of biologics.

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.

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