EMA Recommends Liver Cancer Drug
EMA recommends orphan drug designation for 4SC's resminostat to treat hepatocellular carcinoma.
German drug developer 4SC AG has announced that resminostat, a drug for the treatment of hepatocellular carcinoma – the most common form of liver cancer – has been recommended for approval by the European Medicines Agency.
The recommendation has been forwarded to the EU commission for the final approval and publication in the community register.
The news follows the recent orphan drug designation granted by the US Food and Drug Administration for the same programme.
4SC CEO Ulrich Dauer said that both designations "emphasise the importance of developing novel therapies in this indication in order to provide effective treatment options to patients suffering from this life-threatening disease".
Related News
-
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute. -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled. -
News Biden's $2 billion Biotech Boost
President Biden issues executive order to bolster U.S. biomanufacturing sector. -
News US FDA grants priority review for Eisai and Biogen's Alzheimer's drug
Decision by US drug regulator on lecanemab expected by early next year -
News Panaxia's medical cannabis facility in Malta gains EU-GMP standard
This second facility gives the company a significant power multiplier for export capacity and geographical reach -
News CPHI Discover: Remote excipient audits are on the increase, but we must do more to develop novel excipients
Ahead of the session, Value Added Excipients to Unlock the Potential of APIs, at CPHI Discover on Thursday 18th May – global pharma’s largest ever virtual gathering – we spoke with one of the speakers, Dr Iain Moor...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance