Once unthinkable, the pioneer biotech firms are jumping in with their own proposals for an abbreviated follow-on biologics regulatory pathway. They recognize that this may be the best time for many years to get a system that builds in rigorous tests for follow-ons.
By Ramsey Baghdadi
Senator Ted Kennedy is close to brokering a deal for additional risk management and postmarket surveillance authority for the Food...
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
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.
