
The US Food and Drug Administration has approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia.

The US Food and Drug Administration has approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia.

Merck & Co. (Whitehouse Station, NJ) has announced restructuring plans that include reducing its companywide workforce by 15% by the end of 2012.

Sanofi Pasteur (Lyon, France) has recalled an additional six lots of its Influenza A (H1N1) 2009 Monovalent Vaccine in prefilled syringes after routine testing found that the antigen content had declined below the specification limit.

Following its recent acquisition of Wyeth, Pfizer has 79 manufacturing plants around the world?43 from Pfizer and 36 from Wyeth-and relationships with about 250 contract manufacturers. It?s a wealth of resources, which altogether make 32,000 SKUs. Now, how to consolidate it all?

Novavax will discontinue negotiations for the previously announced collaboration with Madrid-based ROVI Pharmaceuticals.

The US Food and Drug Administration will collaborate with PATH to advance development of a conjugate vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia.

Vivalis (Nantes, France) has acquired Humalys SAS, a private French biotech research and development company based in Lyon, specialized in the generation of human MAbs.

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).

Watson Pharmaceuticals has acquired Eden Biodesign for $15 million.

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.

London-based pharmaceutical company AstraZeneca plans to slash 8,000 jobs, or 12% of its work force, by 2014 to cut costs.

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.

The results of BioPharm International's fourth annual salary survey, conducted in the fall of 2009, shows that women lag behind their male counterparts.

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.


Genzyme (Cambridge, MA) will outsource fill-and-finish operations for its drugs Cerezyme, Fabrazyme, Myozyme, and Thyrogen to Illinois-based Hospira, Inc.

This article presents ongoing research at VIDO-InterVac for the development of safer and more effective adjuvants. These include adjuvants that stimulate innate immunity in the body and combination adjuvants.

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).

Sanofi Pasteur, the vaccines division of France-based Sanofi-Aventis Group, is voluntarily recalling about 800,000 doses of H1N1 (swine) flu vaccine meant for children between the ages of 6 months and 35 months because quality assurance tests indicate the vaccine doses lost some potency.

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.