Notizie AIOM – anno XVII
FDA announces Project Facilitate to assist physicians seeking access to unapproved therapies for patients with cancer
June 3, 2019 - Today, the U.S. Food and Drug Administration Oncology Center of Excellence announced a new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer. A new call center called Project Facilitate ...Leggi tutto
FDA Streamlines Expanded Access for Oncology Agents
June 3, 2019 - The FDA has unveiled what it describes as a pilot “concierge service” for oncologists and patients seeking information and assistance with expanded access (EA) to investigational therapies. The two-pronged program is called Project Facilitate, ...Leggi tutto
FDA Accepts BLA for Luspatercept in MDS, Grants Priority Review in Beta-Thalassemia
June 5, 2019 - The FDA has accepted a biologics license application (BLA) for the investigational erythroid maturation agent luspatercept for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring ...Leggi tutto
FDA Grants Momelotinib Fast Track Designation in Myelofibrosis
June 5, 2019 - The FDA has granted momelotinib a fast track designation for use as a treatment of patients with intermediate- or high-risk myelofibrosis who previously received a JAK inhibitor. Sierra Oncology, the developer of the JAK1/JAK2/ACVR1 inhibitor, announced that ...Leggi tutto
Consultation on draft guideline on quality requirements for medical devices in combination products
June 3, 2019 - EMA has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation. The guideline addresses the new obligations in Regulation ...Leggi tutto
Cancer mortality in Europe in 2015, and an overview of trends since 1990
Cancer mortality in Europe has been decreasing since the late 1980s or 1990s though with different patterns in many areas. In this work, we updated trends in cancer mortality in Europe. We extracted data from the World Health Organization mortality database for 24 cancer ...Leggi tutto