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Regeneron

Latest Headlines

Latest Headlines

Sanofi, Regeneron capture a shot at first-mover advantage in the PCSK9 market

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.

What's next for next-gen sequencing? Everything.

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 nabs FDA 'breakthrough' tag for diabetic eye disease

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.

Rare disease could be the gateway to billions for PCSK9 drugs

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 tops Zetia, fueling PCSK9's blockbuster bluster

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.

Can Amgen sue its way to the top of the PCSK9 pile?

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.

Promising asthma trial prompts Regeneron, Sanofi to push dupilumab into PhIII

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.

Sales speedster Eylea faces a tougher track in new DME market, Regeneron SVP says

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 a first: Regeneron cuts forecast after hard-charging Eylea sales miss

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.

Eyeing Eylea's heirs, Regeneron spends more and more on R&D

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.