Ramsey Baghdadi
After your first visit with the Food and Drug Administration in the Washington, DC suburbs to discuss your new product...
Welcome to Pink Sheet
Create an account to read this article
Already a subscriber?
Fashionably Early: When to Make Your Case to CMS
Manufacturers used to look at Medicare coverage as an afterthought to FDA approval. Now, CMS has a simple message for biopharmaceutical companies: plan ahead. CMS senior officials explain what manufacturers should be thinking about when they come to the agency about reimbursing new products.
More from Platform Technologies
• By
Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
• By
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.
• By
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.
• By
Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA
More from Advanced Technologies
• By
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
• By
Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.
• By
The removal of CBER Director Prasad comes after a wave of right-wing backlash to his appointment over the past few days that was also critical of his decision to ask Sarepta to suspend all sales of the DMD gene therapy Elevidys. FDA reversed its decision the day before Parsad's departure.