Cole Werble
How Wyeth Plans to Make Prevnar a $3 Billion Vaccine
Wyeth's conjugated pneumococcal vaccine continues to break records. The company boldly says there is a lot of growth left, enough to take the product through $3 billion a year and perhaps to $4.5 billion. No vaccine has ever reached those heights. Can Wyeth pull it off?
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Many platform designation requests have been from sponsors eager to cite other sponsors’ products, but CBER Director Peter Marks said in an interview with the Pink Sheet his office likely is years away from accepting those applications.
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CBER Director Peter Marks outlines a streamlined process to approval for treating different mutations of the same gene. NCATS’ Philip Brooks tells the Pink Sheet the approach avoids the need to “start from scratch for every new mutation.”
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Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
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Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.