Tag:
flu vaccine
Latest Headlines
Latest Headlines
Agency OKs Fluarix, opening spigot of vaccine supplies
The FDA has approved GlaxoSmithKline's Fluarix, opening up a supply of 8 million doses of vaccine for the coming flu season. GSK provided about half that much vaccine last season as the FDA allowed emergency shipments to flow into the US following the sudden closure of Chiron's Liverpool facility. Yesterday, the FDA gave that manufacturing site a green light to start production again, another move likely to insure easy availability of vaccine this year. While Fluarix does not …
Investors bid up Novavax shares on news of vaccine success
Shares of Novavax shot up this morning after the company announced that its experimental vaccine for avian flu protected animals. Investors bid up Novavax shares by 38 percent after learning from a study in Vaccine that the Novavax drug evidently worked by eliciting an immune response without infecting cells. Researchers are studying Novavax technology, which requires shorter lead times than traditional methods for developing vaccines. "Our VLP technology, based on a …
Acambis researching single-shot solution to flu
Shares of the UK's Acambis surged this morning as the drug developer announced it would soon begin human trials on a new flu vaccine that could potentially offer permanent protection against all types of flu. Investors were cheered by the prospect that a successful set of trials could offer global protection against the flu, which each year requires huge sums and massive shipments of drugs that may have no effect on whatever strain of the flu is making the rounds. In addition, Acambis …
Sinovac Biotech gets Chinese license to make flu vaccine
Sinovac Biotech said that China's State Food and Drug Administration (SFDA) issued a production license for Sinovac's proprietary influenza flu vaccine, Anflu. Though the company already had won a new drug certificate from the Chinese government for the vaccine, it required a separate license to start production. The company has established its flu production line, which has a capacity of 2 million doses per year. Sales are expected to begin in the last quarter of 2005.- read …
Chiron curtails vaccine distribution for upcoming flu season
After announcing several days ago that it had run into sterility problems at its German facility responsible for producing the Begrivac flu vaccine, Chiron now says that it won't be able to provide any of that vaccine outside of the US for the upcoming flu season. Chiron says it will look to other products to make up for the shortfall. The move comes soon after Chiron sharply cut its forecasted production of Fluvirono.- read this report from TheStreet.com for more
FDA wants to see more data on Chiron's Pulminiq
The FDA says Chiron's experimental therapy to prevent lung transplant rejection-- Pulminiq-- is "approvable," but needs new studies to prove its effectiveness to regulators. An FDA advisory panel said last June that the therapy seemed safe but questioned whether the trial included enough subjects to prove it was effective. Pulminiq is an inhaled version of cyclosporine, which is already approved for use in preventing the rejection of organ transplants. Chiron acquired Pulminiq from …
GSK outlines planned vaccine product launches
In a much anticipated pipeline update, GlaxoSmithKline says it plans to launch five major vaccines over the next five years that have a potential market value of $11 billion to $18 billion by 2010. At the top of the pipeline are Cervarix and Rotarix-- both the subject of ongoing talks with the FDA-- followed by Streptorix for pneumococcal disease. GSK also discussed plans to double its output of flu vaccine in the wake of the Chiron closure during the last flu season.- read …
SPOTLIGHT: MedImmune touts new FluMist version
MedImmune says that a late-stage trial of a refrigerator-stable version of its FluMist flu vaccine was successful in demonstrating its effectiveness. The Gaithersburg, Maryland, biotech has been sorely disappointed in FluMist sales to date. Story
Chiron cuts vaccine projections
Shares of Chiron dropped this morning after the company announced that production delays and manufacturing issues forced it to project a shortfall in vaccine production and revenue. Chiron cut its forecast of 25 million to 30 million doses of flu vaccine to 18 million to 26 million. The move comes after Chiron was forced to shutter its vaccine plant in the UK last fall after British regulators discovered contamination problems in the plant.- read this story from the AP for more
GSK seeks FDA approval of Fluarix
GlaxoSmithKline has moved for FDA approval of its flu vaccine Fluarix. If approved, it would become the fourth flu vaccine approved for the US market and could help stabilize the market for the drug. Last season's decision to shutter Chiron's UK plant for flu vaccine eliminated half the needed supply of flu vaccine in the US. GSK sells Fluarix in 75 countries and provided some of the drug to US distributors last winter on an emergency basis. "Right now a limited number of …
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