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An old saying goes, "Success has a thousand fathers; failure is an orphan."

Dr. Arzu Selen joins FDA's Office of New Drug Quality Assessment (Rockville, MD, www.fda.gov/cder) as the associate director for biopharmaceutics.

Genentech (South San Francisco, CA, www.gene.com) announced on November 9 that it will acquire Tanox, Inc. (Houston, TX, www.tanox.com), a biotechnology company specializing in the discovery and development of biotherapeutics based on monoclonal antibody technology.

Dr. Roberto Machuca has been named operations manager at Ace BioSciences (Odense, Denmark, www.acebiosciences.com).

A recent study by the Tufts Center for the Study of Drug Development (CSDD, http:csdd.tufts.edu) shows that development costs are higher for biotechnology products than previously estimated development costs for traditional pharmaceuticals.

Merck & Co., Inc. (Whitehouse Station, NJ, www.merck.com) will purchase Sirna Therapeutics (San Francisco, CA, www.sirna.com), a biotechnology company developing a new class of medicines based on RNA interference (RNAi) technology, for $1.1 billion.

Lyle Flom has been promoted to senior director of site operations for San Antonio at DPT Laboratories, Ltd. (San Antonio, TX, www.dptlabs.com).

William Slikker, Jr., PhD, has been appointed Director for the National Center for Toxicological Research (NCTR, www.fda.gov/nctr).

The US Food and Drug Administration (FDA) issued a new guidance September 28 to help manufacturers develop safe and effective cell-based viral vaccines.

Gilead Sciences, of Foster City, CA (www.gilad.com), has agreed to acquire Myogen for about $2.5 billion, a move aimed at gaining ownership of Ambrisentan, a treatment for pulmonary arterial hypertension that is in late-stage clinical trials.

Dutch biotechnology company Crucell N.V. (Leiden, The Netherlands, www.crucell.com) has purchased Florida-based Berna Products Corp. from Acambis.

The US Food and Drug Administration says the final version of "Quality Systems Approaches to Pharmaceutical Good Manufacturing Practice (cGMP) Regulations," issued September 29, will help manufacturers maintain consistent high quality while allowing them to make technological improvements more easily.

GTC Biotherapeutics (Framingham, MA, http://www.gtc-bio.com) and LFB Biotechnologies (France) have signed an agreement to collaborate in the development of selected recombinant plasma proteins and monoclonal antibodies using GTC's transgenic production platform.

Pfizer has agreed to purchase PowderMed (London, England, www.powdermed.com), a British company that develops DNA-based vaccines.

XOMA Ltd. (Berkeley, CA, http://www.xoma.com) and Affimed Therapeutics AG (Heidelberg, Germany, www.affimed.com) have signed a cross-license and collaboration agreement for antibody-related technologies.

Malcolm Rollins, PhD, has been appointed manager of projects and process development at QSV Biologics (www.qsvbiologics.com).

A new pharmaceutical industry benchmarking study found that better manufacturing performance results when operations staff make key decisions.

Leonard Kanavy joins Genentech (www.gene.com) as vice president of commercial operations.

A new biotech consortium in the UK believes it can develop tools to improve biopharmaceutical process development.

Celsis International plc (Chicago, IL, www.celsis.com) has acquired In Vitro Technologies, Inc. (Baltimore, MD, www.invitrotech.com).

Pfizer (New York, NY, www.pharmtech.com) will license TransTech Pharma's (High Point, NC, www.ttpharma.com) portfolio of large- and small-molecule compounds that target the receptor for advanced glycation end products (RAGE), which have potential use in treating Alzheimer's disease.

TcLand S.A. (Nantes, France, www.tcland-biotech.com) has named Alain Huriez, MD, one of the company's co-founders, as Chairman and CEO.

PerkinElmer Inc. (Wellesley, MA, www.perkinelmer.com) has acquired Avalon Instruments Limited (Belfast, Northern Ireland).

Syntaxin Ltd. (Wiltshire, UK, www.syntaxin.com), a 2005 spinout from the UK Health Protection Agency, has entered into a research and license arrangement with Allergan (Irvine, CA, www.allergan.com).

Recent announcements of several new biopharmaceutical development and manufacturing sites point to the continued growth and internationalization of the industry, as European-based companies expand operations in the US and vice-versa.

The bioreactor manufacturer Applikon Biotechnology, Inc. (Foster City, CA, www.applikon.com) has signed an agreement with process-controls company Finesse, LLC (Santa Clara, CA, www.finesse-inc.com).

Idenix Pharmaceuticals, Inc. (Cambridge, MA, www.idenix.com) has appointed John F. Weidenbruch to the position of executive vice president and general counsel.

Avecia (Tees Valley, UK, www.avecia.com) has appointed Peter Williams to the position of Quality Director for its biologics business.

Serono, Inc. (Rockland, MA, www.serono.com) has named Paul Lammers, MD, as its US Chief Medical Officer.

Drugs developed by the fastest companies each gained an average of $1.1 billion in incremental prescription revenue and saved an average of $30 million in out-of-pocket development costs, compared to those of the slowest companies, according to Tufts University's Center for the Study of Drug Development (CSDD).