Tag:

Amgen

Latest Headlines

Latest Headlines

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 Amgen's marketing muscle vault its Humira biosim ahead of rivals?

The market for Humira is a large one: the med raked in $11.02 billion last year to top the list of the world's best-selling drugs. So it's no surprise that biosimilar developers are going after a piece of that market--including Amgen, which released some head-to-head data last week that could help it make its regulatory case.

Amgen eyes a speedy approval for its leukemia contender

Amgen is angling for an early FDA nod for the leukemia treatment blinatumomab, racing to market with what the company hopes will be the first of many cancer therapies derived from its proprietary T cell platform.

Amgen declares a head-to-head PhIII win for Humira biosimilar

Amgen has taken a big stride toward gaining regulatory approval for its biosimilar of Humira, AbbVie's megablockbuster anti-inflammatory. The Big Biotech reports today that its knockoff of Humira--dubbed ABP 501--hit its marks on equivalency for efficacy and safety for treating plaque psoriasis. 

Amgen goes to FDA early with new leukemia drug

Amgen is hoping to redeem its drug development rep by going to the FDA with an application for its new leukemia drug blinatumomab based on promising Phase II data, FierceBiotech reports.

Amgen pushes for early FDA OK of leukemia drug blinatumomab

Bolstered by a breakthrough drug designation at the FDA, Amgen is following through with a new drug application for its leukemia drug blinatumomab, hoping that promising Phase II data will be enough to push this program past the goal line on a greatly accelerated development schedule.

It's megablockbuster halfsies for Sanofi, Amgen in next new cholesterol market

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.

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.

Amgen submits melanoma-fighter T-Vec to EMA on the heels of its FDA filing

Back in June, Amgen said it was eyeing a U.S. application for its cancer-fighting viral vaccine in the short term but would be looking outside the U.S. as well. After submitting its candidate to the FDA in July, the company now says it's turned over a marketing authorization application to the European Medicines Agency for the melanoma candidate.

Servier and Amgen's cardio drug faces uncertain future after trial flop

Ivabradine, a heart rate-reducing drug from Servier and Amgen, failed to beat placebo in a huge study of patients with coronary artery disease, potentially clouding its future on two continents.