News

According to a report released by the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO), the three most common types of influenza strains have changed in such a way that they are now showing signs of resistance to the Tamiflu and Relenza vaccines

The US Pharmacopeia (USP) held an official grand opening celebration on March 3, 2008, for its new global headquarters in Rockville, MD.

“We need to improve our ability to measure protein variants in real time and understand how to correlate to biological significance,” commented Duncan Low, PhD, scientific executive director at Amgen, in a January 28 presentation at the IFPAC 2008 meeting in Baltimore, Maryland.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, has announced that the reorganization of the Office of Surveillance and Epidemiology (OSE) has been completed.

Franz B. Humer has stepped down as chief executive officer (CEO) of the Roche Group (Basel, Switzerland), after holding that title for 10 years.

PDL BioPharma, Inc. (Redwood City, CA) announced on March 4, 2008 that it will no longer actively pursue the sale of the company or of its biotechnology discovery and development assets.

Laureate Pharma, Inc. (Princeton, NJ), has appointed Gary Swan vice president of operations.

Pfizer, Inc. (New York, NY) will acquire Serenex, Inc. (Durham, NC), a biotechnology company with a Phase 1 clinical candidate and an extensive compound library that targets Heat Shock Protein 90 (Hsp90), a target in the fight against cancer.

Sangamo BioSciences, Inc. (Richmond, CA) has entered into a second research and license agreement with Genentech, Inc. (South San Francisco, CA), expanding on the original agreement to include additional targets for potential improvement of production cell lines using Sangamo's proprietary zinc finger DNA-binding protein nuclease (ZFN) technology

EUSA Pharma (Oxford, UK) has out-licensed the exclusive worldwide rights to its preclinical-stage human anti-interleukin-6 antibody to GlaxoSmithKline (GSK, Middlesex, UK) for consideration of up to $44 million

Saint-Gobain Performance Plastics Corporation (Aurora, OH) has acquired the assets of J & J Scientific Products, Inc. (Tampa, FL), a manufacturer of disposable plastic products for the biopharmaceutical market.

Novozymes (Bagsvaerd, Denmark) will collaborate with Upperton Limited (Nottingham, UK), a company specializing in novel nanoparticle-based drug delivery systems.

Sanofi Pasteur (Lyon, France) has shipped six million doses of its Stamaril yellow fever vaccine in response to the to the yellow fever epidemic in Latin America.

When considering how follow-on biologics will be compared to innovator products, Emily Shacter has a favorite question

On March 10, 2008, US Food and Drug Administration Commissioner Andrew von Eschenbach, MD, announced that Janet Woodcock, MD, has been appointed director of the agency's Center for Drug Evaluation and Research (CDER), following a national search.

ESBATech AG (Zurich, Switzerland) has achieved high concentrations of its antibody fragments in all segments of the eye with topical delivery via eye drops.

Most small and mid-size biopharmaceutical companies still handle most regulatory filings on paper, recent industry research shows, despite the fact that larger companies and regulators are rapidly shifting toward an electronic environment.

German authorities have received a cluster of reports of adverse reactions to heparin products that are similar to the reactions previously reported to the US FDA, causing the German authorities to initiate a recall of heparin products.

The US FDA has approved Arcalyst (rilonacept, an interleukin-1 blocker) for the long-term treatment of two cryopyrin-associated periodic syndrome (CAPS) disorders.

The FDA has found what it is calling a "heparin-like" compound in the API of heparin that is not heparin.

Following the partial recall initiated on January 25, 2008, Baxter Healthcare has expanded its recall of heparin.

On February 21, 2008, a congressional committee sent letters to Baxter Healthcare and the FDA seeking information related to the recent heparin recall.

Genentech has been notified that their Cabilly patent claim has been rejected by the US Patent and Trademark Office.

On February 22, 2008, the FDA approved two biotech drugs, Avastin (bevacizumab) and HUMIRA (Adalimumab), for additional indications.

Polyplus-transfection (New York, NY), has announced the production of its transfection reagent in vivo-jetPEI, manufactured in full compliance with good manufacturing practices (GMPs).

Novartis Vaccines and Diagnostics (Marburg, Germany) received a warning letter on January 24, 2008, citing significant deviations from current good manufacturing practices (cGMP) in the manufacture of its rabies vaccine (RabAvert) and diphtheria and tetanus toxoids adsorbed concentrate (without preservative), with regard to bulk lot production and process controls and investigations.

Cobra Biomanufacturing Plc (Keele, UK) has entered into a manufacturing development agreement with GenVec, Inc. (Gaithersburg, MD) for TNFerade.

Eli Lilly and Company (Indianapolis, IN) has completed its licensing and development agreement with BioMS Medical Corp. (Edmonton, Alberta, Canada).