News

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.

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).

A public database of extractables and leachables data would save time, effort, and costs during drug development, agreed participants at the CMC Strategy Forum on Extractables and Leachables on January 27.

Robert F. Friel has been elected chief executive officer of PerkinElmer, Inc. (Waltham, MA).

Venture capitalists will largely direct their investments to the greentech and biotech industries in the coming year, while China and India remain hot destinations for venture funds, according to a recent survey by the auditing firm KPMG.

Laureate Pharma, Inc. (Princeton, NJ) has entered into a cGMP contract manufacturing agreement with ARIUS Research, Inc. (Toronto, Canada) for its Trop-2 signal transduction antibody program.

The US FDA has requested nearly $2.4 billion for its fiscal 2009 budget, a 5.7% increase over the budget that FDA received for the current fiscal year.

BioProfile® FLEX can reduce cell culture analysis time, labor, and operating costs by consolidating up to 15 key cell culture attributes – including chemistry/gases/electrolytes, cell density/viability, and osmolality -- into a single, easy-to-use workstation.

Eden Biodesign Ltd. (Liverpool, UK) and iQur Ltd. (Southampton, UK) have entered into an agreement to develop iQur’s tandem core vaccine for hepatitis A and B.

Sheldon Berkle has resigned as president, chief executive officer, and member of the board of directors of Altus Pharmaceuticals, Inc. (Cambridge, MA).

A needle-free vaccine platform that elicits a robust immune response against a wide array of viruses and bacteria has been awarded a US patent (#7,314,624 B2), held by the University of Michigan (Ann Arbor, MI).

A vaccine against the most common and deadliest strain of avian flu, H5N1, has produced a strong immune response in mice and protected them from death following infection.

James A.D. Smith, president, chief executive officer, and director of Genelabs Technologies, Inc. (Redwood City, CA) has resigned.

Bayer HealthCare (Leverkusen, Germany) has withdrawn the current liquid formulation of Leukine marketed in the US following consultation with the US Food and Drug Administration (FDA).