Agency guidance does not require coprimary, dual responder endpoint for drugs developed for knee cartilage repair, so in Histogenics' view, door is still open for approval.
Histogenics Corp. believes that the US FDA will accept data from a Phase III study of its knee cartilage cell therapy NeoCart for review, even though the study failed the primary endpoint, because the firm believes the data meet a lower bar for approval now accepted by the agency.
The company will be requesting a "Type A" informational meeting with the FDA after reporting results from a Phase III...
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.
The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served by hearing from an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.
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.
Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.
The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
