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The US Food and Drug Administration (FDA) has approved an efficacy supplemental biologics license application (sBLA) for Eisai Corporation of North America’s (Woodcliff Lake, NJ) ONTAK (denileukin diftitox).

Millipore Corporation (Billerica, MA) and Applikon Biotechnology BV (Schiedam, The Netherlands) have announced an agreement to co-develop and distribute disposable bioreactor systems for biopharmaceutical applications.

Frederic Chereau has been named president and chief executive officer of Pervasis Therapeutics, Inc. (Cambridge, MA).

MedImmune (Gaithersburg, MD) has licensed its proprietary reverse genetics intellectual property to Omninvest, a Hungarian research and manufacturing company, to support the development and construction of new vaccine strains to produce non-live human influenza vaccines.

BAC BV (Naarden, The Netherlands) has announced the expansion of its collaboration with GE Healthcare with the addition of new bioprocess affinity chromatography media to GE Healthcare’s range of custom-designed media.

The US Food and Drug Administration (FDA) has approved New York City-based Lev Pharmaceuticals’ Cinryze [C1 inhibitor (human)] for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), also known as C1 inhibitor deficiency.

The US Food and Drug Administration (FDA) has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE, West Lafayette, IN) a contract to develop the science behind Quality by Design (QbD) and design space specifications

A centralized quality control strategy may be the best solution.

The US Food and Drug Administration has approved Talecris Biotherapeutics’ (Research Triangle Park, NC) Gamunex as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).

MedImmune (Gaithersburg, MD) has licensed its proprietary reverse genetics intellectual property to BIKEN, the Research Foundation for Microbial Diseases of Osaka University in Japan, to support the development of new vaccine strains to produce non-live human influenza vaccines.

Rainer Lichtenberger, PhD, has been appointed the new chief executive officer of CEVEC Pharmaceuticals (Cologne, Germany).

Genentech, Inc. (South San Francisco, CA) has appointed Morgan Sheng, MD, PhD, vice president, neuroscience.

Massachusetts continued to establish itself as an important hub for biopharmaceutical research and product development with the opening of the University of Massachusetts Lowell’s (UMass Lowell) fully automated BioManufacturing Pilot Plant and Genzyme’s (Cambridge, MA) new Science Center in September.

New investments by two different pharmaceutical companies in programs to manufacture biologics in tobacco plants are reviving hope in the promise of plant-made pharmaceuticals.

Nomad Bioscience GmbH (Munich, Germany) has entered into a broad licensing agreement with Bayer Innovation GmbH (Düsseldorf, Germany) and Icon Genetics group (Halle, Germany).

The Texas A&M University System (College Station, Texas) and XOMA, Ltd., (Berkeley, CA), have signed an agreement to explore options for developing and manufacturing antibodies and protein-based therapeutics for human and veterinary applications.

To reduce the risks involved in outsourcing pharmaceutical operations to Asia, many Western firms are increasingly taking an “insourcing” approach, a new report says.

A new test developed by the US Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses has been cleared by the FDA.

The boards of directors of Eli Lilly and Company (Indianapolis, IN) and ImClone Systems, Inc. (New York, NY) have approved a definitive merger agreement under which Lilly will acquire ImClone through an all cash tender offer of $70.00 per share, or approximately $6.5 billion.

Eli Lilly acquires Imclone

Eli Lilly (Indianapolis, In) is the mystery bidder "in advanced talks" to acquire ImClone Systems (New York, NY).

In biomanufacturing today, there is increasing focus on improving process development. The goal is to accelerate development and reduce costs, without compromising the ability to scale up to a robust commercial process later on.

Human Genome Sciences (HGS, Rockville, MD, www.hgsi.com) has recently entered into manufacturing partnerships with Hospira (Lake Forcest, IL, www.hospira.com) and Eden Biodesign (Liverpool, UK, www.edenbiodesign.com).

Biotechnology company ImClone Systems (New York, NY) has rejected the offer it received last month from its cancer drug partner Bristol-Myers (BMS, New York, NY) to acquire ImClone for $60 per share.

Pfizer Inc. (New York, NY) and Medivation, Inc. (San Francisco, CA) have joined forces to develop and commercialize Dimebon, Medivation’s investigational drug for treating Alzheimer’s disease and Huntington’s disease.

Christopher S. Henney has been appointed chairman of the board of Anthera Pharmaceuticals Inc. (San Mateo, CA).

Artelis SA (Brussels, Belgium) and Selexis SA (Geneva, Switzerland) have announced  manufacturing yields of more than 31 grams per liter in a CHO-based monoclonal antibody production process, in multiple harvests from a perfusion-like process.

Novavax, Inc. (Rockville, MD) has announced favorable results from the second stage of the Phase 1/2a human clinical trial of its pandemic influenza virus-like particle (VLP) vaccine candidate.

The North Carolina Biotechnology Center has announced the five sponsoring companies chosen for the first year of its Industrial Fellowship Program.

Robert Leisk has joined Biokinetics as a senior vice president responsible for international biopharmaceutical business development for projects emanating from North America.