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PCSK9 drugs

Latest Headlines

Latest Headlines

Sanofi, Regeneron lay groundwork for PCSK9 rollout with Cholesterol Counts campaign

No question that the marketing people at Sanofi are excited about alirocumab, the next-generation cholesterol drug that's expected to make its debut next year. Analysts are talking about multibillion-dollar sales, and recent trial data--not just from Sanofi and its partner Regeneron--may build optimism even further.

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.

Amgen takes another stride in frenzied race toward the PCSK9 finish line

Amgen now has a deadline in place for an FDA decision on its cholesterol-lowering drug evolocumab. The Big Biotech put out the word Monday morning that the FDA has accepted its BLA application on the PCSK9 drug for review, giving regulators until August 27, 2015 to issue their decision on marketing the therapy.

Amgen sues to block Sanofi and Regeneron at the PCSK9 goal line

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.

Can Sanofi/Regeneron's new data one-up Amgen in megablockbuster PCSK9 field?

When is cholesterol fighting a game of six of one, half dozen of the other? Could be when the contest is between Amgen and its PCSK9 inhibitor evolocumab, and Sanofi and Regeneron's rival alirocumab. Despite some dramatic new data from the latter team--and a first-up filing with the FDA by Amgen--analysts figure on a dead heat once the drugs hit the market.

Sanofi, Regeneron point to potential heart benefit in PCSK9 data dump

The development team from Sanofi and Regeneron journeyed to the ESC Congress in Barcelona this weekend to detail the impact their late-stage PCSK9 drug alirocumab has on bad cholesterol, drawing some high-profile attention for a batch of preliminary numbers suggesting a trend toward lower cardiovascular risks.

PCSK9 race heads to the finish line with Amgen's evolocumab application

Amgen has taken another big step in its head-to-head race with Sanofi and Regeneron, filing its application for the prospective cholesterol blockbuster evolocumab and backing it up with more positive data from the latest in a long string of major clinical studies.

Sanofi, Regeneron pay $67M for a shortcut in the blockbuster PCSK9 race with Amgen

Sanofi and Regeneron just stole a march on Amgen in the race to get their PCSK9 cardio drug through the FDA and onto the market. The two companies revealed Wednesday evening that they had picked up a priority review voucher BioMarin had won for a recent rare disease drug approval, paying $67.5 million for the regulatory shortcut. They'll split the cost and share in the benefit, shaving four months off the regulatory review time for alirocumab.