AMGEN INC.: Amgen Receives CHMP Positive Opinion To Add Updated Overall Survival Data To KYPROLIS® (carfilzomib) Label
Label Variation to Include Overall Survival Data From Phase 3 ENDEAVOR Trial Read More »
Label Variation to Include Overall Survival Data From Phase 3 ENDEAVOR Trial Read More »
Amgen and Humana Inc. will collaborate on finding opportunities to improve health outcomes by analyzing the real-world health care experiences of Humana's 13 million members. Read More »
Amgen and Allergan submitted a Biologics License Application for ABP 980, a biosimilar candidate to Herceptin, to the U.S. Food and Drug Administration. Read More »
California-based Amgen recently obtained U.S. Food and Drug Administration (FDA) acceptance of its Biologics License Application (BLA) for Aimovig (erenumab), a product developed specifically to help victims of frequent migraine headaches. Read More »
Amgen and UCB recently announced that their Evenity study, which analyzed the drug as a treatment for postmenopausal women with osteoporosis, met both primary endpoints and the secondary endpoint. Read More »
Amgen of Thousand Oaks, California and Array BioPharma of Boulder, Colorado recently created a cooperative contract to develop innovative drugs aimed at combating autoimmune disorders after Array’s breakthrough discovery of certain target and lead inhibitors. Read More »
HedgePath Pharmaceuticals Inc. (HPPI) recently announced that the U.S. Food and Drug Administration (FDA) granted the company’s Type-C Guidance Meeting Request for further guidance on HPPI’s Phase 2(b) clinical trial analyzing SUBA-Itraconazole (SUBA-Cap) oral capsule usage in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome. Read More »
Amgen's Xgeva Phase 3 study, the largest international multiple myeloma trial ever conducted, met its primary endpoint by demonstrating that the drug is non-inferior to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma. Read More »
Amgen's Phase 2 study evaluating Imlygic combined with Yervoy as a treatment for patients with unresectable Stage IIIB-IV met its primary endpoint. Read More »
Via tax-free allotment to company shareholders, Rennova Health Inc. intends to transition its Advanced Molecular Services Group to a publicly traded entity by late September pending appropriate paperwork with the SEC and other conditions. Read More »
Amgen recently announced that its Mimpara drug has been given a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency. Read More »
A prescription chemotherapy drug manufactured by Florida-based Breckenridge Pharmaceutical Inc. has earned Food and Drug Administration approval, moving a step closer to combating a rare type of blood and bone marrow cancer. Read More »
Amgen recently presented 19 scientific abstracts at the 59th Annual Scientific Meeting of the American Headache Society, which took place in Boston. Read More »
Amgen and Allergan's data supporting their Biologics License Application for ABP 215, a biosimilar candidate to Avastin (bevacizumab), will be reviewed by the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration by July 13. Read More »
Amgen's Fourier trial for Repatha met its primary composite endpoint and the key secondary composite endpoint. Read More »
TapImmune Inc. has completed a multi-gram scale-up and GMP manufacturing of a second clinical lot of TPIV 200, which is a multi-epitope T-cell vaccine developed by the company that targets the folate receptor alpha. Read More »
Amgen announced May 18 a Biologics License Application which they submitted to the U.S. Food and Drug Administration for a migraine prevention medication. Read More »
Amgen announced May 2 that they had signed an outcome-based refund contract with Harvard Pilgrim for Amgen's Repatha. Read More »
Amgen recently shared positive results for its Fourier Trial, which is evaluating whether Repatha reduces the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease. Read More »
The European Commission has adopted a decision to change the Repatha (evolocumab) marketing authorization, approving a new single-dose delivery option. Read More »