Regulatory
Medicines on the list can still be prescribed but will be under tight monitoring by a regulatory network, which can implement measures to prevent shortages and ensure supply chain continuity.
Ahead of an expected surge in regulatory filings, the FDA is establishing the Genetic Metabolic Diseases Advisory Committee to provide advice on treatments for these complex and challenging conditions.
The companies have received all required regulatory approvals to complete the deal, the largest for the sector in the past three years and the biggest for the hot antibody-drug conjugate market.
Following the regulator’s administrative complaint and threat of a lawsuit in federal court, Sanofi has decided to terminate its licensing deal with Maze Therapeutics to avoid a long litigation process.
Friday’s FDA approval of Vertex-CRISPR’s Casgevy and bluebird bio’s Lyfgenia has immediately revealed startling differences between these two gene therapies: price and a black-box warning.
Along with CRISPR/Cas9-based Casgevy—developed by Vertex Pharmaceuticals and CRISPR Therapeutics—the regulator on Friday approved bluebird bio’s Lyfgenia, a second gene therapy for sickle cell disease.
As Vertex and CRISPR Therapeutics’ exa-cel and Verve Therapeutics’ VERVE-101 move forward, questions remain about possible drawbacks of such therapies.
The regulator has accepted Bristol Myers Squibb’s Opdivo and the chemotherapy cisplatin for priority review in patients with unresectable metastatic urothelial carcinoma, as well as Merck and Seagen’s first-line combo.
The regulator placed a partial clinical hold on Roche’s fenebrutinib—being developed for relapsing MS—after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury.
The European Medicines Agency is seeking additional information from the makers of GLP-1 drugs as part of its ongoing review of the potential risk of suicide and self-harm thoughts associated with the class.
PRESS RELEASES