What's better than a new drug launch? A launch destined for greatness, of course. For sales and marketing teams, that's about as much job security as you can get.
Regeneron chief Len Schleifer has topped the ranks of biopharma's highest-paid skippers for the past couple of years now, and though his salary may be rising still, being CEO doesn't quite come with all the perks it used to.
A new generation of cardiovascular drugs has proved itself capable of lowering bad cholesterol across dozens of Phase III trials, but many physicians are holding out to see whether doing so can meaningfully improve patients' lives. In an early peek at some long-term data, one such injected therapy from Amgen halved the risk of major cardiovascular problems after one year of treatment, bolstering the case for the whole class of drugs.
Regeneron and its close partner Sanofi have posted another set of promising results for dupilumab--which targets the interleukin-4 and interleukin-13 inflammatory proteins--from a Phase IIb study that backs up those high expectations.
Regeneron's eye drug Eylea picked up steam against two competing products from Roche, as the first head-to-head study comparing the meds found that Eylea outperformed Lucentis and Avastin in treating moderate to severe vision loss in patients with diabetic macular edema.
The antibody experts at Regeneron believe their in-development allergy treatment could be the next big thing at the Big Biotech, rolling toward the market with a potential blockbuster.
Amgen just lost a key regulatory race. Armed with a handy FDA shortcut voucher, Regeneron and its Big Pharma partner Sanofi announced today that the agency has accepted their application for the powerful new PCSK9 cholesterol drug alirocumab and set a priority deadline of July 24 for their marketing decision. If they get a quick green light, as many analysts expect, their decision to buy the priority review voucher will be rewarded with first-mover advantage with U.S. payers as Amgen sits out an FDA game clock that ends August 27.
SAN FRANCISCO--More than a few presentations at the JP Morgan Healthcare conference this week sought to address the future of next-generation sequencing, particularly with the huge waves of related news.
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.