Amgen's (AMGN) AMJEVITA Approved by U.S. FDA

Amgen (AMGN) Announces Erenumab Phase 3 Met Primary Endpoint in Migraine Prevention

September 28, 2016 4:31 PM EDT

Amgen (Nasdaq: AMGN) announced positive top-line results for erenumab (AMG 334) from A Phase 3, RandomIzed, double-blind, placebo-controlled Study to Evaluate the efficacy and safety of erenumab in migraine prevention (ARISE). These data showed the ARISE study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients with episodic migraine treated with erenumab compared with placebo at 12 weeks. Erenumab is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor, which is believed to have a critical role in mediating the incapacitating pain of... More

Amgen (AMGN) Announces KYPROLIS Phase 3 CLARION Trial Missed Primary Endpoint

September 27, 2016 5:52 AM EDT

Amgen (NASDAQ: AMGN) announced top-line results of the Phase 3 CLARION trial, which evaluated an investigational regimen of KYPROLIS (carfilzomib), melphalan and prednisone (KMP) versus Velcade® (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 percent CI, 0.75 - 1.10). While the data for overall survival, a secondary endpoint, are not yet mature, the observed hazard ratio (KMP versus VMP) was 1.21 (95... More

FDA Approves Amgen's (AMGN) Biosimilar to AbbVie's (ABBV) Humira

September 23, 2016 4:09 PM EDT

(Updated - September 23, 2016 4:11 PM EDT)

The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.

Amjevita is approved for the following indications in adult patients:

moderately to severely active rheumatoid arthritis;active psoriatic arthritis;active ankylosing spondylitis (an arthritis that affects the spine);moderately to severely active Crohns disease;moderately to severely active ulcerative colitis; andmoderate to severe plaque psoriasis.

Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients... More

UnitedHealth trims drug coverage, including Sanofi insulin

September 22, 2016 8:25 AM EDT

(Reuters) - UnitedHealth Group (NYSE: UNH), the largest U.S. health insurer, will stop covering several brand-name drugs as of next year, reinforcing a trend of payers steering prescriptions to lower-priced options.

In a bulletin seeking client feedback by Sept. 28, UnitedHealth said it is changing reimbursement terms for long-acting insulins and will no longer cover Lantus, the main insulin drug sold by Sanofi .

The insurer said Basaglar, a cheaper biosimilar insulin sold by Eli Lilly (NYSE:... More