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.
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.
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.
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.
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 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.
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.
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.
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.
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.