Pfizer, Lilly and the other marketers of drugs for erectile dysfunction are kicked out of Medicare and Medicaid. Viagra and the other brands may be the first victims of the backlash against DTC advertising. They are also a case study in how Congress can--and well--make mischief under the Medicare program.
By Michael McCaughan
Where is Bob Dole when you need him? Congress has cut off federal spending on drugs to treat erectile dysfunction,...
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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.
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
Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
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.
