On its Q2 earnings call, Regeneron said its 8mg formulation of aflibercept could obtain US FDA approval this quarter, despite receiving a complete response letter in June. Refiling’s fate tied to review of pozelimab.
Regeneron Pharmaceuticals, Inc. gave investors some unexpected potential good news during its second quarter sales and earnings call on 3 August, saying that its US filing of high-dose Eylea may obtain approval during the current quarter, perhaps even before the end of August, following a US Food and Drug Administration complete response letter on 27 June.
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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.
