After meeting with FDA to discuss the status of its Advair generic application in the US, Mylan said it will not have to conduct additional clinical trials and is on target to respond to the complete response letter soon.
Mylan NV aims to get its application for a generic version of GlaxoSmithKline PLC's asthma blockbuster Advair Diskus (fluticasone/salmeterol) back in the US FDA's court soon. During the company's second quarter earnings call Aug. 9, President Rajiv Malik said the company would be ready to respond to the complete response letter received from FDA "in the next couple of weeks."
The update on the important application comes after Mylan met with FDA to discuss the CRL and clarified that it...
Merck’s immuno-oncology blockbuster was the world’s best-selling drugs by revenues for the second year in a row, with an almost $12bn lead over its closest rival, Novo Nordisk’s GLP-1 drug Ozempic.
Nancy tests Jira ticket SPARC-1036: Make anchor link work on initial page load
2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.
Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.
Companies stand a better chance of securing public reimbursement in Mexico for innovative medicines if they understand changing approaches to healthcare. The shift means the emergence of managed entry agreements and a focus on economic impact, explains AMIIF, Mexico's research-based pharmaceutical industry association.
Novartis’s APMA chief outlines the company’s tailored approach to deliver long-term outcomes, novel access solutions via innovative financing options and shape the CVD disease ecosystem in the extraordinarily diverse region. Partnering to build AI infrastructure is another key prong.
A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.
