Radius's Tymlos Dawdles At CHMP, No EU Opinion Yet
Executive Summary
Radius Health has a new CEO, but the company's path to the EU market for its novel osteoporosis therapy Tymlos looks still subject to questions at this week's meeting of the European Medicines Agency’s CHMP.
You may also be interested in...
Orphans Dominate Products Seeking End-Of-Year Joy From CHMP
Five of the nine products that could this week be recommended for EU approval have orphan designation. The final meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London.
US FDA Sends Amgen/UCB Evenity Back With BRIDGE Request
The US FDA has surprised no-one with a Complete Response Letter for Amgen and UCB's novel osteoporosis treatment Evenity but, with luck, analysts say the product might still reach the market in 2018-19 and garner sales over £500m.
Nine Pivotal Studies To Look Out For In 2024
While not expected to be quite so busy as previous years, 2024 will still see many pivotal clinical trial readouts that should create a splash. Here are nine (plus a few extras) that have caught attention for one reason or another, e.g., for being the first readout for a novel drug class, having the potential to take a product in a new lucrative direction, for maybe being able to succeed where a rival has already failed or even for having been a long time coming.