News

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.

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.

Cytos Biotechnology AG (Schlieren, Switzerland) has entered into an exclusive global research, option, and license agreement with Pfizer Vaccines LLC (Pfizer, New York, NY) to research, develop, manufacture, and commercialize novel vaccines for a defined number of human diseases.

Scott Neilson has been appointed to the position of Chief Operating Officer of AAIPharma.

Pall Corporation (East Hills, NY) has purchased GeneSystems (Bruz, France), a privately held biotechnology company that has developed a molecular diagnostics platform.

Chemists are reporting a major advance toward developing a safer, fully-synthetic version of heparin, the widely used blood thinner currently produced from pig intestines.

The American biotech giant Genentech, Inc. has rejected an offer by the Swiss drug-maker Roche to acquire the 44% of Genentech it does not already own, but said it would be willing to consider a higher bid.

On August 6, the FDA released a guidance entitled Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States.

Bridge Laboratories (Gaithersburg, MD), a preclinical contract research organization, will build its second preclinical facility in China.