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An in-depth analysis of blood from patients recovering from the H5N1 avian influenza virus has provided important insights into how to combat the potentially lethal virus.

In its latest setback, Discovery Labs (Warrington, PA) has failed to receive FDA approval for the fourth time for Surfaxin (lucinactant).

Millipore Corporation (Billerica, MA) and Microbix Biosystems, Inc. (Toronto, Canada), have formed a collaboration to develop a novel purification process for influenza virus vaccine manufacturing.

Members of the pharmaceutical and biotech industries have formed a new industry coalition, called "Rx-360," with the goal of improving supply chain safety.

Merck & Co., Inc. (Whitehouse Station, NJ), Medarex, Inc. (Princeton, NJ), and Massachusetts Biologic Laboratories (MBL, Jamaica Plain, MA) of the University of Massachusetts Medical School (UMMS) have signed an exclusive worldwide license agreement for CDA-1 and CDB-1.

In response to requests from the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration has authorized the use of the antiviral drugs Tamiflu and Relenza beyond their approved indications in response to the outbreak of swine flu.

The current outbreak of the H1N1 influenza strain is exactly the kind of situation the vaccine company Novavax (Rockville, MD) has been preparing for over the last three years.

A new excipient monograph standard for recombinant human albumin (HSA) became official in the United States Pharmacopeia-National Formulary (USP-NF) today, and Novozymes Biopharma (Nottingham, UK) says that its "Recombumin" and "Albucult" products are the first to comply with the new standard.

In response to requests from the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration yesterday authorized the use of the antiviral drugs Tamiflu and Relenza beyond their approved indications in response to the outbreak of swine flu.

Centocor Ortho Biotech (Horsham, PA), a subsidiary of Johnson & Johnson, received approval from the US Food and Drug Administration on April 24 for Simponi (golimumbad), a monthly treatment for moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

Novavax, Inc. (Rockville, MD), has formed a joint venture with Cadila Pharmaceuticals, Ltd. (Ahmedabad, India), to develop, manufacture, and market vaccines, pharmaceuticals, and diagnostic products in India.

Roche (Basel, Switzerland) will acquire 100% of Innovatis, AG (Bielefeld, Germany).

Covance Inc. (Princeton, NJ) has completed an additional 8,000-sq. ft. to its biotechnology services facility in Harrogate, UK.

SAFC Biosciences (Lenexa, KS) has completed the conversion of its dry powder cell culture media continuous milling production site in Lenexa, KS to animal component free (ACF) status. This is the first of several similar conversions planned by SAFC Biosciences to support growing customer requirements for ACF manufacturing.

The US Food and Drug Administration has released a new draft guidance on somatic cell therapies that are designed to advance the treatment of heart disease through the regeneration of cardiac tissues.

ImClone Systems, Inc. (Branchburg, NJ), and Bristol-Myers Squibb (BMS, New York, NY) voluntarily recalled 13 lots of their cancer drug Erbitux (cetuximab) after a report from a doctor?s office about a leaking cap on a vial of the biologic.

Pall Corporation (East Hills, NY) has acquired an exclusive license to manufacture, market, and sell Single Pass TFF (SPTFF), an SPF Innovations, LLC (Watertown, MA) technology for biopharmaceutical applications.

When the final version of the Quality by Design (QbD) case study is made public this summer, it will be an aspirational document, says Ken Seamon, PhD, one of the project?s facilitators. "If the regulatory authorities read our final document and said 'yes, this is all fine,' we will have failed," he said.

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.

ImClone Systems, Inc. (Branchburg, NJ), and Bristol-Myers Squibb (BMS, New York, NY) voluntarily recalled 13 lots of their cancer drug Erbitux (cetuximab) after a report from a doctor?s office about a leaking cap on a vial of the biologic.

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.