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Amgen

Latest Headlines

Latest Headlines

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.

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.

Amgen successfully hits another PhIII goal line with kidney dialysis drug

Amgen successfully wrapped its second Phase III study for AMG416, its late-stage drug for secondary hyperparathyroidism that's now one final study away from a prospective regulatory filing.

Survival miss for Amgen's Kyprolis may hurt approval chances in Europe

A Phase III late-stage myeloma miss for Amgen's Kyprolis didn't shock analysts, who said the failure was more or less expected when the company announced trial results Wednesday. But without proof that the med prolongs life in those patients, getting Kyprolis by European regulators could be a tough sell.

Amgen recalls Aranesp syringes contaminated with polyester

Amgen is recalling 9 lots of an anemia drug from 14 countries outside of the U.S. after syringes were found to have cellulose and polyester particles in them. The recall comes at a tough time for Amgen's manufacturing operations, which were just targeted for big cuts to prepare the company for future competition to a key product.

Amgen builds case for bigger Kyprolis market with impressive second-line data

Amgen put out the word Monday that adding Kyprolis to combo therapy with Celgene's Revlimid beat out the Revlimid combo alone in melanoma patients who had relapsed.