Jazz and PharmaMar need to see what further data will be needed to convert their FDA authorization into a full approval following disappointing results in the ATLANTIS Phase III trial.
Jazz Pharmaceuticals and its partner PharmaMar, S.A. look likely to need another trial to support the full US approval of their novel anticancer Zepzelca in small-cell lung cancer after the Phase III ATLANTIS study missed its overall survival (OS) primary endpoint.
Zepzelca (lurbinectedin) received an accelerated approval from the US Food and Drug Administration in June for the treatment of adult...
The Netherlands-headquartered company is enjoying huge success with Vyvgart in two autoimmune conditions, with a new prefilled syringe version reaching more patient groups.
François Roger believes fixing inefficiencies is more important than playing with pricing.
The Phase IIb study failed its primary and a key secondary endpoint, but showed activity on another key secondary and an exploratory endpoint.
GSK is sticking to its guns on its forecasts for Blenrep and the firm’s total sales in 2031 despite concerns about the antibody-drug conjugate’s approvability in the US.
GSK is sticking to its guns on its forecasts for Blenrep and the firm’s total sales in 2031 despite concerns about the antibody-drug conjugate’s approvability in the US.
PTC plans to compete with BioMarin’s two phenylketonuria drugs with efficacy data showing strong reduction of phenylalanine and ability for patients to liberalize their diets.
The BRUIN CLL-314 trial was designed to show noninferiority, but the p-value indicated a favorable result for Jaypirca in both the pre-treated and intent-to-treat populations.
