News

The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) issued a revised draft guidance on July 20 to help ensure that the safety, purity, and potency of biologics products is not compromised as a result of innovative, flexible manufacturing arrangements.

Genzyme Corp. (Cambridge, MA, www.genzyme.com) and the Oswaldo Cruz Foundation (FIOCRUZ, www.fiocruz.br) have announced plans to collaborate on research into new drugs focusing on neglected diseases.

Biotech giant Amgen (Thousand Oaks, CA, www.amgen.com) will shrink its workforce by 12–14 %, or approximately 2,200–2,600 employees, as part of its strategy to save more than $1 billion next year.

Lonza (Basel, Switzerland, www.lonza.com) purchased Zyentia's (Cambridge, UK, www.zyentia.com) Aggresolve technology, a comprehensive in silico protein analysis platform that can be applied to problem solving of protein aggregation, for an undisclosed sum.

New Brunswick Scientific (www.nbsc.com) has incorporated Allen Bradley PLC controls into its BioFlo Pro fermentors and bioreactors for system regulation, as well as easy exchange of data with auxiliary bioprocessing systems.

SemBioSys Genetics, Inc. (Calgary, Canada, www.sembiosys.com) announced that it has successfully produced commercial levels of apolipoprotein AI and its variant apolipoprotein AI(Milano), collectively referred to as Apo AI, in safflower seed lines.

Silence Therapeutics (London, England, www.silence-therapeutics.com) has appointed Jeffrey Scott Vick as Group CEO.

The August 7, 2007, issue of The Wall Street Journal Patent Scorecard ranks Wyeth (Madison, NJ, www.wyeth.com) first among 35 global pharmaceutical companies evaluated for patent-based intellectual property (IP).

The US Pharmacopeia (USP, Rockville, MD, www.usp.org) board of trustees has elected René H. Bravo, MD, as president of the USP convention for the remainder of its 2005–2010 cycle.

Roche Pharmaceuticals (Basel, Switzerland, www.roche.com) has named Severin Schwan, PhD, the current head of diagnostic division, new chief executive.

Genentech, Inc. (South San Francisco, CA, www.gene.com), has announced an agreement with Tercica, Inc. (South San Francisco, CA, www.tercica.com), for the development, manufacture, and commercialization of two products containing Genentech?s recombinant human growth hormone Nutropin AQ (somatropin, rDNA origin) and Tercica?s recombinant insulin-like growth factor-1 Increlex (mecasermin, rDNA origin) for the treatment of short stature, adult growth hormone deficiency (AGHD), and potentially other metabolic disorders.

The US Pharmacopeia (Rockville, MD, USP, www.usp.org) recently announced that the implementation period for its USP­–NF general notices statement requiring all manufacturers to conform to recently revised residual solvent standards in General Chapter <467> has been extended from July 1, 2007 to July 1, 2008.

Karen Daniels has joined Althea Technologies, Inc. (San Diego, CA, www.altheatech.com), as president of the company's bio-services division.

Acambis plc (Cambridge, UK, www.acambis.com) has initiated a Phase 1 clinical trial of its universal influenza vaccine candidate, ACAM-FLU-A.

The US FDA (Rockville, MD, www.fda.gov) recently announced the availability of a draft guidance, entitled, Q10 Pharmaceutical Quality System.

FDA has named Virginia Behr as the Center for Drug Evaluation and Research (CDER, www.fda.gov/cder/) ombudsman.

NanoMed Pharmaceuticals, Inc. (Kalamazoo, MI, www.nanomedpharm.com), has appointed Harry C. Ledebur, Jr., PhD, as the company's vice president of research and development and chief scientific officer.

Novartis Vaccines (Basel, Switzerland, www.novartisvaccines.com) plans to produce approximately 40 million doses of its Fluvirin vaccine for distribution in the US during the upcoming 2007–2008 influenza season-a 30% increase in supply from Novartis compared with the previous influenza season.

The Kobio pump from Bioengineering (www.bioengineering.ch) has three pneumatically actuated diaphragm valves arranged in a series.

Althea Technologies, Inc. (San Diego, CA, www.altheatech.com), has been contracted by GeoVax Labs, Inc. (Atlanta, GA, www.geovax.com), to manufacturer its HIV-1 DNA vaccine.

In late June and early July, the US Congress moved forward on three important bills affecting the biopharmaceutical industry, related to follow-on biologics, the Prescription Drug User Fee Act (PDUFA), and the 2008 FDA budget.

Roche (Basel, Switzerland, www.roche.com) and the biopharmaceutical company Alnylam Pharmaceuticals, Inc. (Cambridge, MA, www.alnylam.com), have entered into a major alliance in which Roche obtains a nonexclusive license to Alnylam's technology platform for developing RNAi (RNA interference) therapeutics.

Indian biotech revenues grew almost 31% to more than $2.08 billion in 2006–2007, according to a recent report.

PepTcell (High Wycombe, UK, www.peptcell.com) recently released preclinical data indication that Flu-V, its new flu vaccine, has the potential to protect against both pandemic and seasonal strains of influenza.

In late June, the European Commission granted marketing authorization for Merck Serono S.A.’s (Geneva, Switzerland, www.serono.com) Pergoveris, the first biologic intended for the stimulation of follicular development in women with severe luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency.

In the April issue of BioPharm International, the article "BioPharmaceutical Operations Roadmap," provided a summary of the key industry gaps executives would like to close in the next 10 years. These goals came to my mind while I was attending Interphex this April in New York.

A Colorado State University (Fort Collins, CO, www.colostate.edu) research team has developed a novel vaccine to prevent tuberculosis (TB).

Avir Green Hills Biotechnology (GHB, Vienna, Austria, www.greenhillsbiotech.com) has started the first clinical Phase 1 study for its novel influenza vaccine FLUVACC. FLUVACC is based on the deletion of the NS1 gene.