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Amgen

Latest Headlines

Latest Headlines

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.

Novartis asks court to take the brakes off Neupogen biosim

Last month, a U.S. appeals court blocked Novartis' biosimilar version of Amgen's blockbuster Neupogen while the companies worked out a patent dispute. Unsurprisingly, though, Novartis wants that ban lifted, and now it's asking the court to do just that.

Merck, Amgen to test Keytruda/T-Vec combo in head and neck cancer

While the FDA deliberates whether to approve Amgen's melanoma-fighting vaccine, T-Vec, as a monotherapy, the California biotech is partnering with Merck to test T-Vec in combination with the PD-1 drug, Keytruda, in patients with head and neck cancer.

Amgen preps an FDA pitch for its late-stage kidney drug

After posting a trio of Phase III victories, Amgen is plotting to submit the kidney dialysis drug AMG 416 for FDA review this year, charging forward with a successor to its own Sensipar.