EMA issues first paediatric use positive opinion
This article was originally published in SRA
Executive Summary
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued its first ever positive opinion for paediatric use marketing authorisation (PUMA) under the new Paediatric Regulation that came into force in 20071.
You may also be interested in...
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.
10 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 ten (plus a few extras) that have caught Scrip’s eye for one reason or another, eg, 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.
Triumvira Takes A Different TAC With T-Cell Therapy For Solid Tumors
The private US/Canadian firm is taking a singular approach to T-cell therapy to tackle both solid and liquid tumors and hopes to have early data to back up its novel technology this year. An IPO could follow.