Clinical Trials Clinical trials test drug candidates for safety and effectiveness. Clinical Trial Basics A clinical trial, also called an interventional study, tests new drugs and treatments. It can also test new applications for approved drugs or treatments (for example, using drugs in different combinations or for different diseases). This is different from an…
The Cure SMA drug pipeline is one of the primary ways we evaluate the success of our research program. The pipeline identifies the major drug programs in development, and tracks their progress from basic research through clinical trials Key Measurements The pipeline measures the progress of our research in two key ways. First, by tracking…
BIOGEN RESPONDS TO COVERAGE RECOMMENDATION BY THE CANADIAN DRUG EXPERT COMMITTEE (CDEC) FOR SPINRAZA, THE ONLY TREATMENT APPROVED FOR TREATMENT OF 5Q SPINAL MUSCULAR ATROPHY (SMA) Ottawa – December 22, 2017 – Today the Canadian Drug Expert Committee (CDEC) made public its recommendation to the Common Drug Review (CDR) participating drug plans to reimburse SPINRAZA…
Dear members of the SMA community, In response to your request for information, we would like to provide you with an update on Biogen’s SMA360 Canada Patient Support Program and the next steps following Health Canada’s approval of SPINRAZA™ (nusinersen). The SMA360 Canada Patient Support Program has been developed to be available for patients and…
We have completed our submission in to CADTH! Thanks to everyone’s support and heartfelt responses, we feel we have a very strong message to the drug review committee expressing the needs of the entire SMA committee for effective treatment and the benefits of Spinraza to improve the lives of all persons and families affected by…
Cure SMA Canada is very happy to announce the approval of nusinersen/spinraza from Health Canada. We are very excited to confirm the approval for treatment for all types of SMA in Canada. We will be communicating with the Canadian sma community our next steps as we move forth into the funding approval process to CADTH’s…
June 4, 2017 Dear members of the SMA community, In response to your request for information, we are delighted to inform you that on June 1 2017 Biogen announced that the European Commission (EC) granted a marketing authorization for SPINRAZA® (nusinersen) for the treatment of 5q spinal muscular atrophy (SMA) which is the most common…
May 4, 2017 In response to your request for information, we would like to inform you that recently the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a marketing authorization in the European Union for SPINRAZA (nusinersen) to treat patients with…
May 4, 2017 Dear members of the SMA community, In response to your request for information, we would like to provide you with an update on Biogen’s global Expanded Access Program (EAP), called the Special Access Program (SAP) through Health Canada. Based on the high unmet need in SMA, and to bridge the gap between…