Tag:
flu vaccine
Latest Headlines
Latest Headlines
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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