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The US FDA (Rockville, MD, www.fda.gov) recently announced the availability of a draft guidance, entitled, Q10 Pharmaceutical Quality System.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

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.

Royal DSM NV (Heerlen, the Netherlands, www.dsm.com) and Dutch biotechnology company Crucell NV (Leiden, the Netherlands, www.crucell.com) have announced a nonexclusive PER.C6 research licensing deal with Sartorius Biotech GmbH (Goettingen, Germany, www.sartorius.com).

The inaugural West Coast meeting for the Clinical Supplies Support Group (CSSG, www.jeiven.com/clinical_supplies_support_group.htm) was held in San Diego on June 8, 2007.

Amgen (Thousand Oaks, CA, www.amgen.com) will acquire Alantos (Cambridge, MA, www.alantos.com), a private company developing drugs for the treatment of diabetes and inflammatory diseases.

AstraZeneca PLC (London, UK, www.astrazeneca.com) has announced the resignation of its CFO Jon Symonds, at the end of July. Symonds joined Zeneca in 1997 as CFO after 17 years at KPMG.

The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) has issued final recommendations for increasing the supply of safe and effective influenza vaccines for both seasonal and pandemic use.

Intas Biopharmaceuticals Limited (IBPL, Gujarat, India, www.intasbiopharma.co.in) has become India's first dedicated biopharmaceutical company to receive certification from the European Agency for the Evaluation of Medicinal Products (EMEA, London, UK, www.emea.europa.eu) or an EU-GMP certification for its manufacturing facility at Ahmedabad, Gujarat.

The BioWelder and BioSealer from Sartorius (www.sartorius.com) are suitable for connecting or disconnecting thermoplastic tubing in biopharmaceutical manufacturing processes.

Kythera Biopharmaceuticals, Inc. (Calabasas, CA, www.kytherabiopharma.com), has appointed Patricia Walker, MD, PhD, as chief medical officer and vice president of clinical development and regulatory affairs.