Manufacturing, Biologic Drugs

MedImmune, Inc. (Gaitherburg, MD) reports that US Food and Drug Administration (Rockville, MD) has approved the company's supplemental biologics license application to use reverse genetics technology to construct new vaccine strains to produce seasonal influenza vaccines.

Biopharmaceutical company Lipoxen PLC (London, UK) has developed a Hepatitis E vaccine using its novel vaccine delivery technology "ImuXen," which the company claims to be easy to manufacture. According to the company, the proprietary liposomal formulation method delivers vaccine materials to the immune system in a manner designed to emulate the response of a natural encounter with the infection agent.

GlaxoSmithKline PLC (GSK, London, UK) will invest more than GBP102 million ($188 million) over the next four years in a vaccine manufacturing plant in Singapore.

The US Department of Health and Human Services (HHS, Washington, DC) will distribute more than $1 billion in contracts to accelerate the development of cell-based production technologies for influenza vaccines.

Novartis (Basel, Switzerland) has closed on its $5.4-billion acquisition of Chiron Corporation (Emeryville, CA), paving the way for the creation of a new Novartis division focusing on vaccines and diagnostics.

Reverse Genetics Avian Influenza Vaccine Approved in France

GSK Begins Clinical Trials of Two H5N1 Vaccines

Cell-culture technology and financial incentives give influenza vaccine makers a much-needed shot in the arm, but many downstream processing issues remain unaddressed.

Progress Continues in Vaccine and Antiviral Development

Chiron Withdraws Measles Vaccine

Development Begins on Mutated H5N1 Virus Vaccine

Novavax, Bharat Biotech Team for Pandemic Influenza Vaccine Development

GSK Gains Approval for Rotavirus Vaccine in Infants; FDA Review Extended for Merck’s Shingles Vaccine

FDA Recommends Changes for 2006-2007 Flu Vaccine

Baxter Wins Contract to Develop Cell-Based H5N1 Vaccine

Cambrex (East Rutherford, NJ) to produce Geron (Menlo Park, CA) telomerase anti-cancer vaccine. Generex (Toronto, ON.) files IND for synthetic vaccine to stimulate cell-mediated immunity to avian influenza. Dow Agrosciences (Indianapolis, IN) wins USDA approval for veterinary vaccine, the first manufactured via plant cell culture. G-8 nations pledge billons for vaccine production.

Merck wins approval for rotavirus vaccine as Sanofi ships investigational H5N1 vaccine to NIH and CDC explores new flue diagnostics and novel vaccine-production technology.

Dow AgroSciences Receives Regulatory Approval for Plant-Made Vaccine

Cell-Grown Vaccine Protects Against Avian Flu Virus

Sanofi Pasteur and BD Team Up to Produce Microneedle Vaccines

SEC Loosens Revenue-Recognition Rules for Vaccine Stockpile Participants

NIAID Boosts Vaccine Innovation but Draws Controversy

Adjuvant for HPV Vaccine Enhances Immune Response Levels

Genecor Wins Vaccine-Development Contract

FDA Calls Chiron Facility Acceptable; GSK Gets Green Light For Flu Vaccine

Bavarian Nordic Sues Acambis for Patent Infringement

Acambis and Bavarian Nordic Vie for Smallpox Vaccine Contract

GSK Releases Flu Vaccine Production Strategies

US Government Orders 2M Doses of Avian Flu Vaccine

Chiron Cuts Supply of Flu Vaccines Made in Germany; Liverpool Plant Under Inspection