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RSS FeedPosted by Michael Wonder on 19 Sep 2019
Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis
18 September 2019 - In this study, the investigators examined the characteristics of randomised controlled trials that supported approval of cancer ...
Posted by Michael Wonder on 18 Sep 2019
FDA issues final guidance to address ‘gaming’ by the use of citizen petitions
18 September 2019 - Today the U.S. FDA issued the final guidance, Citizen Petitions and Petitions for Stay of Action Subject ...
Posted by Michael Wonder on 18 Sep 2019
FDA continues steps to promote innovation in medical devices that help advance patient safety through the Safer Technologies Program
18 September 2019 - Today, the Food and Drug Administration issued draft guidance titled “Safer Technologies Program for Medical Devices,” ...
Posted by Michael Wonder on 18 Sep 2019
Three-year-old Matilda's ability to walk is giving hope to those with spinal muscular atrophy
18 September 2019 - The disease, which has been described as motor neurone disease for children, is the leading cause of ...
Posted by Michael Wonder on 18 Sep 2019
NICE recommends Takhzyro
18 September 2019 - NICE - a health technology appraisal body in England and Wales - has recommended the use ...
Posted by Michael Wonder on 18 Sep 2019
'A child's health should not be a postcode lottery': anger of cystic fibrosis sufferers forced to pay £20,000 for drug abroad
17 September 2019 - Patients have formed a buyers' club to source a version of Orkambi after the drug's manufacturer and ...
Posted by Michael Wonder on 18 Sep 2019
Susan G. Komen Big Data for Breast Cancer Initiative: how patient advocacy organisations can facilitate using big data to improve patient outcomes
12 September 2019 - Integrating different types of data, including electronic health records, imaging data, administrative and claims databases, large data ...
Posted by Michael Wonder on 18 Sep 2019
FDA grants breakthrough therapy designation for Roche’s Gazyva (obinutuzumab) in lupus nephritis
18 September 2019 - There are currently no U.S. FDA approved medicines for lupus nephritis. ...
Posted by Michael Wonder on 18 Sep 2019
Biofrontera files label extension for Ameluz in EU to include treatment of actinic keratosis on extremities and trunk/neck
17 September 2019 - Biofrontera has filed a label extension for Ameluz with the EMA on August 28, 2019 to include ...
Posted by Michael Wonder on 18 Sep 2019
Vertical Pharmaceuticals announces submission of new drug application for RVL-1201
17 September 2019 - Vertical Pharmaceuticals today announced the submission of a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 18 Sep 2019
U.S. FDA approves supplemental new drug application for Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer
17 September 2019 - Phase 3 TITAN is the first registrational study to achieve statistical significance in dual primary endpoints of ...
Posted by Michael Wonder on 17 Sep 2019
Provisional approval of lenvatinib in combination with pembrolizumab for the treatment of advanced endometrial carcinoma
18 September 2019 - The Therapeutic Goods Administration has provisionally approved the use of lenvatinib (Lenvima) in combination with pembrolizumab ...
Posted by Michael Wonder on 17 Sep 2019
Price controls for Medicare don't put America first
17 September 2019 - Instead of embracing drug price controls, the U.S. should pressure other nations to abandon them. ...
Posted by Michael Wonder on 17 Sep 2019
News NHS England explores funding options for cystic fibrosis drug
17 September 2019 - NHS England is “committed to exploring and developing alternative routes” to enable people with cystic fibrosis ...
Posted by Michael Wonder on 17 Sep 2019
FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma
17 September 2019 - The U.S. FDA is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence. ...
Posted by Michael Wonder on 17 Sep 2019
Does anyone really ‘love’ private health insurance?
17 September 2019 - I am alive today not because of insurance companies but despite them. ...