GSK's Cervarix HPV vaccine is going to miss another back-to-school vaccination season in the US, giving Merck even more time to cement its lead with Gardasil. The delay surprised Wall Street-but shouldn't have. FDA is exercising caution about the approval of a second HPV vaccine - one containing a new active adjuvant. The final approval will set new standards for the coming wave of adjuvant-enhanced vaccines.
Cole Werble
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The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.
