Tag: UCB Pharmaceuticals (UCB)

Amgen and UCB granted FDA approval of Evenity for osteoporosis in menopausal women at risk of bone fracture

Amgen and UCB granted FDA approval of Evenity for osteoporosis in menopausal women at risk of bone fracture

Amgen (AMGN) and UCB announced that the U.S. Food and Drug Administration (FDA) has granted approval of Evenity™(romosozumab-aqqg) for osteoporosis in postmenopausal women at high risk for bone fracture. Evenity is different from all other osteoporosis products as it is a bone builder that increases bone formation and, to a lesser extent, reduces bone loss and, consequently, reduces the risk of fracture. A full course of …
The FDA committee voted 19 to 1 in favor of approving Amgen’s & UCB’s new osteoporosis product Evenity

The FDA committee voted 19 to 1 in favor of approving Amgen’s & UCB’s new osteoporosis product Evenity

On January 8, 2019 the osteoporosis monoclonal antibody Evenity (romosozumab) developed by Amgen and UCB was granted approval by the Japanese Ministry of Health, Labor and Welfare for osteoporosis in patients at high risk of bone fracture. Yesterday, Amgen (AMGN) and UCB (Euronext Brussels: UCB) announced that 19 out of 20 members of the  U.S. FDA, Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted YES for the approval of Evenity™ for osteoporosis …
Amgen and UCB product for bone fracture in susceptible postmenopausal women. What about the Market’s deep dips?

Amgen and UCB product for bone fracture in susceptible postmenopausal women. What about the Market’s deep dips?

Another reason was found to hit the market when the economy is good and sustained and expected to be of a long duration. Of a short duration are the causes presented as economy killers. They are almost all related to China. We believe that the negotiations between China and the United States on the tariffs and other subjects will end up in favor of both …
Amgen and UCB resubmit BLA to the FDA for the approval of Evenity™ to prevent or heal Osteoporosis bone fracture in post-menopausal women

Amgen and UCB resubmit BLA to the FDA for the approval of Evenity™ to prevent or heal Osteoporosis bone fracture in post-menopausal women

The BLA Includes Data from More Than 11,000 Patients Amgen (AMGN) and UCB (Euronext Brussels: UCB) resubmitted a Biologics License Application (BLA) to the U.S. FDA for the approval of their osteoporosis investigational monoclonal antibody product Evenity™ (romosozumab). The product is indicated for osteoporosis in postmenopausal women at high risk for fracture.The drug increases bone formation and reduces bone resorption simultaneously to increase bone mineral …
Amgen: Positive Data from Osteoporosis Trial. Aerie Pharmaceuticals: More Data on Glaucoma Drug Safety.

Amgen: Positive Data from Osteoporosis Trial. Aerie Pharmaceuticals: More Data on Glaucoma Drug Safety.

Amgen (AMGN) and UCB (Euronext Brussels: UCB) announced positive results from the BRIDGE pivotal Phase 3 placebo-controlled study evaluating the efficacy and safety of romosozumab in treating men with osteoporosis.  The study met the primary endpoint, demonstrating a statistically significant increase in bone mineral density (BMD) at the lumbar spine in men with osteoporosis treated with romosozumab compared with placebo at 12 months. All secondary endpoints comparing romosozumab with placebo …
Osteoporosis: Romosozumab from Amgen Succeeds in Preventing Bone Fracture

Osteoporosis: Romosozumab from Amgen Succeeds in Preventing Bone Fracture

AMGEN AND OSTEOPOROSIS Amgen And UCB Announce Positive Top-Line Results From The Phase 3 Study of Romosozumab In Postmenopausal Women With Osteoporosis The FRAME Study Met All Primary Endpoints by Reducing the Incidence of New Vertebral Fracture Through 12 and 24 Months Amgen (AMGN)and UCB (Euronext Brussels: UCB): Top-line results from the Phase 3 placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME). The results  showed …