News

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.

A team of Wyeth (Madison, NJ, www.wyeth.com) scientists involved in the discovery, development, and manufacture of Prevnar-pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein)-was awarded the 2005 National Medal of Technology by President George W. Bush at a White House ceremony in late July.

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The US FDA (Rockville, MD, www.fda.gov) recently announced the availability of a draft guidance, entitled, Q10 Pharmaceutical Quality System.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

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.

Vical Incorporated (San Diego, CA, www.vical.com) has introduced a cell-free manufacturing process designed to produce large quantities of vaccine in a matter of days, compared with the several months required for conventional vaccine production.

Roche (Basel, Switzerland, www.roche.com) has opened its new biotechnology production center in Basel.

The members of the VBU Association of German Biotech Companies (www.v-b-u.org) have unanimously elected Uwe Gottschalk, VP of purification technologies at Sartorius Biotech GmbH (Goettingen, Germany, www.sartorius.com), to the board.

The FDA issued MedImmune, Inc. (Gaithersburg, MD, www.medimmune.com), a warning letter for violating the agency's manufacturing rules and held off approving the company's influenza vaccine for use in children younger than age five until the problems are resolved.

The federal government will be awarding a $500 million contract to Bavarian Nordic A/S (Kvistgård, Denmark, www.bavarian-nordic.com) to deliver 20 million doses of an advanced smallpox vaccine.

A consortium led by Cobra Biomanufacturing (Keele, UK, www.cobrabio.com) has been awarded a £1.1m grant from the UK Department of Trade and Industry to evaluate the application of Cobra’s proprietary ORT-VAC vaccine technology.

Pharmaceutical Product Development, Inc. (PPD, Wilmington, NC, www.ppdi.com), has selected William J. Sharbaugh as its new chief operating officer.

Dendreon Corporation (Seattle, WA, www.dendreon.com) received a complete response letter, commonly referred to as an "approvable" letter, on May 8, 2007, from the FDA regarding its biologics license application (BLA) for Provenge (sipuleucel-T) for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.