Biocon is awaiting a scheduled FDA pre-approval inspection for insulin aspart at its facility in Malaysia, amid concerns that the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.
Front-line Indian companies like Biocon, Ltd. have a lot riding on regulatory inspections going through as scheduled amid pandemic-related travel restrictions to countries where plants are located.
The Bengaluru-based firm indicated that the US Food and Drug Administration had scheduled a pre-approval inspection of its manufacturing facility...
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.
Ordspono, a bispecific antibody newly approved in the EU to treat follicular lymphoma and diffuse large B-cell lymphoma, joins Libtayo in Regeneron’s growing oncology portfolio.
Nemluvio is a first-in-class IL-31 inhibitor that the US FDA approved for prurigo nodularis.
CEO Bill Anderson would not be drawn on whether the drug, currently approved for chronic kidney disease associated with type 2 diabetes, will hit a previous forecast of €3bn peak sales, but expansion into heart failure may make that figure look conservative.
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.
