Roche/Abbvie’s first-in-class breakthrough BCL-2 inhibitor granted accelerated approval by FDA in relapsed CLL with 17p deletion.
Accelerated approval of Roche/AbbVie Inc.’s Venclexta (venetoclax) in chronic lymphocytic leukemia with the 17p deletion mutation is just the beginning for a drug that has demonstrated impressive response rates and is being positioned for a range of blood cancers.
Venetoclax (previously known as ABT-199) targets the protein B-cell lymphoma 2 (BCL-2), which is often over-expressed in CLL
EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.
Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.
DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.
EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.
Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.
