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
GlaxoSmithKline PLC no longer expects the human papilloma virus vaccine Cervarix
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Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA
The UK’s drug regulator is developing a “clear and streamlined” regulatory pathway for individualized cancer mRNA immunotherapies.
mHealth data generated by smartphones and wearables show potential for enhancing the clinical evidence used in regulatory decision-making, but there are “notable challenges” that may hinder the use of such data, EU regulators say.
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.
The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.
Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.
Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.
