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?
Cole Werble
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PhRMA questioned whether proof-of-concept studies are needed before an INTERACT meeting and said a draft guidance describing the timing of definitive toxicology studies creates confusion.
Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.
A new chapter that will be published in the European Pharmacopoeia soon is expected to provide a comprehensive framework for the production and quality control of cell-based preparations. Meanwhile, an existing chapter has been revised to facilitate the implementation of rapid microbiological testing methods.
