Roche's Lucentis may now have a bigger jump on Eylea in diabetic retinopathy. The Swiss drugmaker's Genentech unit won the FDA's "breakthrough" designation for that indication on Monday. And Lucentis was already on the FDA's priority review track, with a decision date in February.
About 1.5 million Americans suffer from familial hypercholesterolemia, an inherited disease that leads to dangerously high cholesterol, and they're likely to be the first targets for a new class of drugs that promise to bring in blockbuster sales.
Sanofi and Regeneron's alirocumab resoundingly beat out Merck's Zetia in helping statin-intolerant patients lower their bad cholesterol in a study, data that bolster the case for a new class of highly anticipated cardio drugs.
In the race to commercialize a new class of potential cardiovascular blockbusters, Amgen and its team of lawyers have filed a patent suit to fend off the advance of rivals Sanofi and Regeneron. But, looking at the patents in question and the history of such challenges, one analyst figures Amgen is unlikely to succeed in keeping its competitors off the market.
Regeneron and its close partner Sanofi have cleared the final mid-stage hurdle for dupilumab in asthma patients, with several doses hitting the trial endpoint both for a subset of patients as well as the broad population. And the ambitious development team at Regeneron now plans to hustle into a pivotal late-stage program as they continue to make swift progress with a drug that promises to tackle a trio of conditions that share a core inflammatory trigger.
Fast-growing wet AMD blockbuster Eylea delivered a surprise Tuesday, failing to surpass analyst expectations with a showing that prompted maker Regeneron to lower full-year sales guidance for the first time in the drug's three-year history.
Here's something Regeneron isn't used to: Cutting sales forecasts for blockbuster eye drug Eylea. But that's just what the New York biotech did Tuesday amid lower-than-expected third-quarter results.
Regeneron is pouring more money than ever into its well-respected R&D operation, spending big on a cadre of late-stage candidates the Big Biotech believes can outshine its blockbuster eye treatment.
Regeneron and Bayer's Eylea has been racking up sales that have consistently topped analyst expectations since its U.S. rollout in late 2011. Now, new data may help it potentially top them in a market Novartis and Roche got to first.
Sanofi and Regeneron have cut to the front of the line in the race to develop a new class of cardio drugs, but now rival Amgen has made a chess move of its own, filing a patent-infringement lawsuit designed to block its rivals from reaching what's expected to be a blockbuster market.