BioPharm International Editors

Intercell AG (Vienna, Switzerland) has received the US Food and Drug Administration?s approval for Ixiaro, a vaccine for the prevention of Japanese Encephalitis (JE).

Novozymes Biopharma UK Ltd. (Nottingham, UK) has signed a license agreement with GE Healthcare Life Sciences (Chalfont St. Giles, UK), which enables Novozymes Biopharma to produce and deliver native, animal-free Protein A using GE Healthcare technology.

Nobilon, the human vaccine business of Schering-Plough Corporation (Kenilworth, NJ), have entered into an agreement with the World Health Organization (WHO, Geneva, Switzerland) to provide access to pandemic influenza vaccine manufacturing technology to developing countries.

Sanofi Pasteur (Lyon, France), the vaccines division of the Sanofi-Aventis Group, has received marketing authorization from the European Commission for the first intradermal (ID) influenza vaccine using BD Soluvia microinjection system developed by BD (Franklin Lakes, NJ).

Biopharmaceutical companies have been seeing the importance of sustainability and green efforts. Two companies in particular have embraced sustainability and green manufacturing.

Genzyme Corporation (Cambridge, MA) has received a complete response letter from the US Food and Drug Administration regarding its application to market Lumizyme (alglucosidase alfa). In its letter, the agency outlines the remaining items that must addressed before the application can be approved. To gain approval, Genzyme must also resolve issues identified in a warning letter that the company received simultaneous to the complete response letter.

GE Healthcare (Chalfont St Giles, UK) has entered into a marketing collaboration with Tecan (Mannedorf, Switzerland) to provide customers with access to both companies' expertise in laboratory automation and process development. The agreement will enable process developers to implement specifically designed protocols and accessories for GE Healthcare's PreDictor 96-well plates on Tecan Freedom EVO workstations. The automation collaboration is designed to reduce hands-on time required for screening process conditions.

ImClone Systems, a subsidiary of Eli Lilly and Company (Indianapolis, Indiana), and Bristol-Myers Squibb (BMS, New York, NY), have received a complete response letter from the US Food and Drug Administration for the first-line squamous cell carcinoma of the head and neck supplemental Biologics License Application (sBLA) for Erbitux (cetuximab).

Novavax (Rockville, MD) has achieved favorable preclinical results for a new pandemic influenza virus-like particle (VLP) vaccine candidate that provided protection against several H5N1 virus strains.

Implicit Bioscience Ltd (Brisbane, Australia) has acquired the clinical-stage monoclonal antibody IC14 from Eli Lilly and Company (Indianapolis, Indiana). Implicit has paid an undisclosed consideration combining cash and stock to Lilly. Lilly will also receive a royalty on future IC14 sales.

Waters Corporation (Milford, MA) and LabVantage Solutions, Inc. (Bridgewater, NJ) have formed a partnership to integrate laboratory software for improved efficiency and effectiveness. Collaborating with existing common customers, Waters and LabVantage have already integrated LabVantage's Sapphire Laboratory Information Management Suite (LIMS) with Waters NuGenesis Scientific Data Management System (SDMS) and Empower 2 chromatography data software (CDS) solutions.

Oxford Expression Technologies (OET, Oxford, UK) and Eden Biodesign (Liverpool, UK) have signed a co-marketing agreement.

Apotex, Inc. (Toronto, Canada) and Intas Biopharmaceuticals Limited (IBPL, Ahmendabad, India) have extended their business agreement to develop a biosimilar version of pegfilgrastim, a protein that is used to treat neutropenia (a side effect of cancer chemotherapy).

The US Food and Drug Administration issued its first approval on February 6 for a biological product produced by genetically engineered animals.

Richter-Helm BioLogics GmbH & Co. KG (Hamburg, Germany) and Athera Biotechnologies AB (Stockholm, Sweden) have signed an agreement for the development and manufacturing of Annexin A5, Athera?s novel product for prevention of plaque rupture and athero-thrombosis.

With counterfeit and adulterated medicines posing an increasing risk to patients in the United States and worldwide, the US Pharmacopeial (USP, Rockville, MD) Convention announced on February 4, new standards for two widely used drug products that have been involved in episodes of adulteration resulting in patient deaths.

Following a discussion with the US Food and Drug Administration, ImClone Systems, acquired last fall by Eli Lilly and Company (New York, NY), and Bristol-Myers Squibb (New York, NY) have withdrawn the supplemental Biologics License Application for the use of Erubitux (cetuximab) in advanced non-small cell lung cancer.

The US Food and Drug Administration has launched a voluntary pilot program that will help promote the safety of drugs and active drug ingredients produced outside the United States.

Teva (Jerusalem, Israel), the world?s largest generics company, and Lonza (Basel, Switzerland) have formed a joint venture to develop, manufacture, and market biosimilars.

Indian biotechnology company Intas Biopharmaceuticals (IBPL, Ahmedabad, Gujarat) has signed a memorandum of understanding (MoU) with the government of Gujarat for setting up a separate manufacturing facility for Monoclonal Antibodies (MAbs).

AmVac AG (Zug, Switzerland) has formed a collaboration with the National Health Research Institutes in Taiwan to develop a nasal spray vaccine against the H5N1 avian influenza.

The US Food and Drug Administration has approved Gleevec (imatinib mesylate) for a new indication?keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor (GIST).

Novozymes (Bagsvaerd, Denmark) has entered into a global licensing and collaboration agreement with Sanofi-Aventis (Paris, France) for the development and marketing of a new potential antibiotic.

Intercell AG (Vienna, Austria) has begun the Phase 2 clinical trial of the company's vaccine candidate to prevent infections with the bacterium Pseudomonas aeruginosa.

Celvapan, the first cell culture-based H5N1 (avian flu) pandemic vaccine, has moved closer to approval in the European Union. On December 18, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA), issued a positive opinion, recommending market authorization for the vaccine, made by Baxter International, Inc. (Deerfield, IL).

AFFiRiS (Vienna, Austria) has initiated pre-clinical development of a Parkinson's vaccine. The vaccine, known as PD01, can be used to target a specific protein that is closely associated with the causes of this degenerative neurological disease.

PPD, Inc. (Wilmington, NC) has entered into a strategic collaboration with Merck & Co., Inc. (Whitehouse Station, NJ), involving vaccine testing and assay development.

On January 20, FDA Commissioner Andrew von Eschenback, MD, will step down as commissioner and Frank Torti, MD, will take over as acting commissioner.

MannKind Corporation (Valencia, CA) has purchased an option to license plant-produced recombinant human insulin from SemBioSys Genetics Inc. (Calgary, Canada) for use primarily in MannKind's ultra-rapid acting insulin, Afresa.

The US Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) opened HHS/FDA offices in Costa Rica on January 7. The HHS/FDA presence in the region will allow the countries to work closely together. The office in Costa Rica is the first in a series in Latin America, which will eventually include an HHS/FDA presence in South America and Mexico later in 2009.