The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday adopted a negative opinion for UCB Pharma’s osteoporosis treatment Evenity (romosozumab), which was approved by the US Food and Drug Administration (FDA) in April.
In a sign that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is being more cautious than the US Food and Drug Administration (FDA), CHMP on Wednesday adopted a negative opinion recommending the refusal of a marketing authorization for Emmaus’s sickle cell disease drug Xyndari (glutamine).
EMA Sees Spike in Medicines Recommendations in 2018
NEW YORK, Sept. 6, 2018 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) today announced the appointment of Robert N. Daly, M.S., Ph.D., to the position of Vice President, Head of Clinical Operations, effective immediately. In this role, Dr. Daly will oversee all clinical operations, with a focus on executing Actinium's progressing pivotal Phase 3 trial for Iomab-B as a targeted conditioning agent, driving forward the Company's growing CD33 program including its advancement in targeted conditioning, as well as future clinical trial expansion for the entire pipeline. He will be supervised by Dr. Mark Berger, Actinium's Chief Medical Officer and will report to Actinium's Chairman and CEO, Sandesh Seth, for strategic and organizational related matters.
J&J and Bayer have run into a major setback in their long-running quest to widen the market for their clot-busting drug Xarelto. Their second crack at finding a safe benefit for at-risk patients facing incidents of venous thromboembolism (VTE) — clots in the deep veins — flopped in a major study of more than 12,000 patients who enrolled in the Mariner trial.
Sixteen medicines recommended for approval, including two orphans
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine1, at its March 2018 meeting.
EMA’s Committee for Medicinal Products for Human Use (CHMP) on Friday adopted negative opinions for two medicines - Dexxience (betrixaban), approved by the US Food and Drug Administration (FDA) in June 2017 as Bevyxxa (betrixaban) to prevent venous thromboembolism, and Eladynos (abaloparatide), approved by the US Food and Drug Administration (FDA) in May 2017 as Tymlos (abaloparatide) for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Helsinn buys global rights for skin cancer drug from Actelion; Akebia reels in more cash for vadadustat; EMA slams Bevyxxa
US-FDA approved the Prior Approval Supplement of Bevyxxa in advance of its Jan 30, 2018, date.