All News

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).

Insmed Inc. (Richmond, VA), has launched an education campaign about the importance of establishing a regulatory pathway in the US for large-molecule protein-based drugs, known as follow-on biologics (FOBs), biosimilars, or biogenerics.

Novartis Vaccines and Diagnostics (Marburg, Germany) received a warning letter on January 24, 2008, citing significant deviations from current good manufacturing practices.

Venture capitalists will largely direct their investments to the greentech and biotech industries in the coming year.

Sinovac Biotech Ltd., (Beijing, China), has announced positive results of a completed Phase 2 clinical trial of its pandemic influenza (H5N1) whole viron inactivated vaccine.

The Parenteral Drug Association (PDA, Bethesda, MD) has announced its 2008 board of directors and officers.

Hawaii Biotech, Inc., (Honolulu, HI), has been notified by the United States Food and Drug Administration (FDA) that it may initiate a 24 patient safety study in healthy human volunteers with its recombinant, subunit West Nile vaccine.

BioPharm International’s second annual salary survey assesses not only how much people earn, but also how they feel about it.

The US Food and Drug Administration has published for public review and comment two annexes to the International Conference on Harmonization’s (ICH) Q4B guideline, Evaluation of Pharmacopeial Texts for Use in the ICH Regions.

The International Conference on Harmonization has released an Annex to its Q8 guideline, Pharmaceutical Development.

The US Food and Drug Administration is soliciting public comments on the report issued by the Science Board Advisory Committee on December 3, 2007.

Crucell NV (Leiden, The Netherlands), has announced that it will receive up to $5 million from the Aeras Global TB Vaccine Foundation (Rockville, MD), to support the development of its AdVac- and PER.C6-based tuberculosis vaccine candidate.

Acambis plc (Cambridge, MA), has announced that, subsequent to the US Centers for Disease Control and Prevention (CDC) order of September 2007, it completed delivery of the entire 2.7 million doses of its ACAM2000 smallpox vaccine to the CDC on December 28, 2007.

Crucell N.V. (Leiden, the Netherlands) has signed an exclusive collaboration and commercialization agreement with Sanofi Pasteur (Lyon, France) for Crucell’s rabies monoclonal antibodies, the next-generation rabies biologicals to be used in association with rabies vaccine for post-exposure prophylaxis against this fatal disease.

Merck Serono (Geneva, Switzerland), a division of Merck KGaA, will collaborate with Flamel Technologies (Lyon, France) to investigate the applicability of Flamel’s Medusa technology for the extended release of a therapeutic protein in Merck Serono’s portfolio.

Nektar Therapeutics (San Carlos, CA) will work with subsidiaries of Baxter International, Inc. (Deerfield, IL), to develop new PEGylated therapeutics for hemophilia.