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Amgen

Latest Headlines

Latest Headlines

UPDATED: Amgen beats Regeneron, Sanofi to world's first big PCSK9 drug OK

Amgen may be running a beat or two behind Regeneron and Sanofi in search of the first FDA approval for a PCSK9 drug, but the Big Biotech scooped up the very first approval in Europe today for Repatha (evolocumab), giving the company boasting rights as first mover in what is widely seen as a new blockbuster market in the making.

Amgen's Blincyto puts leukemia patients in remission, building its case for a new FDA nod

Amgen's working to expand the label of cancer-fighter Blincyto, and on that front, it's got some solid new data to help it make its case.

Amgen's latest immuno-oncology drug comes through in Phase II

Amgen's new immuno-oncology treatment demonstrated promising efficacy in a midstage trial on a rare blood cancer.

Amgen's migraine drug gains momentum in a crowded race

Amgen says that its experimental migraine drug boosted its response rate among patients over a full year of therapy, a little bit of an edge that could help it compete against a group of rivals now hustling ahead with pivotal studies.

Amgen's Vectibix hits PhIII survival goal in previously treated mCRC patients

The treatment trumped best supportive care in patients who had failed to respond to chemo, posting a statistically significant improvement in overall survival to nail the primary endpoint of a Phase III study.

Docs enthused about coming PCSK9 meds--and ready to prescribe

After last week's expert panel meetings, the FDA may put some label limits on PCSK9 cholesterol drugs. But Sanofi, Regeneron and Amgen can take heart. 

Ready to prescribe PCSK9 meds? Doctors say yes, yes, yes

After last week's expert panel meetings, the FDA may put some label limits on PCSK9 cholesterol drugs. But if word from doctor surveys is any indication, those limits won't put a huge damper on sales.

Upstart Kezar wrangles $23M to pick up where Onyx left off

South San Francisco startup Kezar Life Sciences is looking to follow through on some promising programs discovered at Onyx Pharmaceuticals, raising $23 million and securing Amgen's blessing as it targets autoimmune disease.

Amgen's cardio contender clears FDA panel, but it's hardly a clean sweep

Amgen won the support of FDA advisers with its potentially game-changing new cardiovascular treatment, but the agency panel cautioned against widespread use of the injection until its long-term safety is better understood.

FDA asks experts to weigh in on PCSK9 drugs' market reach for Amgen, Regeneron/Sanofi

The blockbuster race between Amgen and a team from Regeneron and Sanofi for cutting-edge PCSK9 drugs comes down to this: back-to-back panel reviews to discuss the designated endpoint for cutting LDL as a surrogate for cardio benefits as well as the potential negative effect these new drugs could have on the massive demand for statins.