Latest Headlines

Latest Headlines

UPDATED: Regeneron, Sanofi and Amgen shares suffer on FDA's frets about PCSK9 class

Some of the leaders in the frenzied late-stage race to develop a PCSK9 drug watched their stock prices stumble on Friday afternoon as word of the FDA's concern about potential neurocognitive side effects in the cholesterol drug class ripped through Twitter.

AbbVie, Amgen and Roche most vulnerable to biosim rivals, Moody's says

As the biosimilar market takes shape, companies are gunning to produce copies of some of the world's top-selling drugs. And according to a new Moody's report, with their star products wearing targets on their backs, AbbVie, Amgen and Roche are most exposed to the new competition.

Amgen responds to FDA warning letter over drug/device combos

Amgen has been issued an FDA warning letter for problems the agency says it found at its plant in Thousands Oaks, CA, which makes prefilled syringes and related devices used for its osteoporosis drug Prolia, and for Enbrel, the autoimmune disease treatment it shares with Pfizer.

The FDA hit Amgen with a warning over drug/device combo manufacturing violations

California biopharmaceutical giant Amgen got smacked with an FDA warning letter alleging quality system manufacturing violations in some of its drug/device combo products. These prefilled syringes and related devices are prepped for osteoporosis and autoimmune treatments.

Dako and Amgen will forge ahead on a new companion Dx test

Demark's Dako and Amgen like working together so much that they're extending their relationship. They've agreed to develop a new molecular diagnostic test in an expansion of an alliance that first began two years ago.

Merck loops Pfizer, Amgen and Incyte in on MK-3475 immunotherapy deal spree

At Merck, the already giant-sized hope that its cancer immunotherapy program for the PD-1 drug MK-3475 represents just swelled significantly in importance. Just ahead of its 2013 earnings report Wednesday, the pharma giant announced plans to tie up with a trio of major league biopharma partners to launch a whole new slate of combination studies that could significantly extend its reach in the oncology market.

The top drug delivery partnerships of 2013

In the biotech and pharma industries, drug delivery is a crucial aspect of research and development. Finding new ways to deliver old drugs, ways to make a new drug more efficient or ways that make a...

Amgen is halting Epogen manufacturing in Colorado

Workers at Amgen's Boulder, CO-area facilities were warned in 2012 to prepare for job cuts. The California-based company said that after a production buildup for a year or so, it intended to halt Epogen production there. Last week, it followed through on the warning, saying the cuts will happen this spring.

Amgen cutting 200 jobs despite improved Epogen sales

Amgen reported a 30% leap in fourth-quarter profits this week, but that is still not enough to save more than 200 jobs at the company's Epogen production operations in Colorado, which were targeted earlier as long-term sales of its anemia franchise have tapered off.

Amgen outpaces its rivals in the race for a PCSK9 blockbuster

Amgen is batting 1.000 in its ambitious clinical program for the promising PCSK9 cholesterol drug evolocumab (AMG-145), unveiling a 5th successful Phase III study as it prepares for an FDA application that could give it first-mover status in a blockbuster field.