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PCSK9 drugs

Latest Headlines

Latest Headlines

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.

Sanofi, Regeneron prep their PCSK9 cardio contender for FDA review after PhIII sweep

Sanofi and Regeneron are heading to the FDA with a potential blockbuster cardiovascular treatment, touting positive results from a slew of Phase III trials in which the drug slashed patients' bad cholesterol.

Amgen pads its PCSK9 lead with latest data on a potential blockbuster

Amgen's in-development cardio drug came through in two more late-stage trials, significantly lowering bad cholesterol in patients with genetic disorders that put them at serious risk.

Payers fret about the next drug doomsday: Pricey PCSK9 cholesterol meds

Pharmacy benefits managers say they're just as worried--perhaps even more so--by a coming class of cholesterol drugs known as PCSK9 inhibitors as they are about the new crop of hepatitis C treatments.

Tomorrow's cardio blockbusters: Inside 'the next big leap' in controlling cholesterol

Thanks to genomic sequencing, some heart-healthy mutants and billions of dollars spent on R&D, rival drug developers are bearing down on a promising new way of treating the scourge of high cholesterol. And with the first FDA applications likely coming in the next year, the nascent field's trailblazers are vying for the top spot with blockbuster aspirations.

Amgen's PCSK9 drug slashes 'bad' cholesterol in PhIII, stoking blockbuster hopes

Amgen widened its lead among competing drugmakers in a promising new field of cardio treatments on the strength of late-stage results in which its in-development drug lowered LDL cholesterol by as much as 75%.

Pfizer says PCSK9 study was a winner, boosting its chances in hectic R&D race

Pfizer says the Phase IIb study for its closely-watched PCSK9 cholesterol drug bococizumab (RN316) scored the primary endpoint on all doses, which should help steer a massive Phase III program that started out last fall with 22,000 patients.