Blog
RSS FeedPosted by Michael Wonder on 22 Sep 2019
Accelerating the shift toward person-generated real world evidence
19 September 2019 - Evidence generated from randomised clinical trials and other clinical studies has long been the foundation for ...
Posted by Michael Wonder on 22 Sep 2019
Merck’s Pifelto (doravirine) and Delstigo (doravirine/lamivudine/tenofovir disoproxil fumarate) receive US FDA approval for use in appropriate adults living with HIV-1 who are virologically suppressed
20 September 2019 - Approvals based on findings from the Phase 3 DRIVE-SHIFT Trial evaluating a switch to Delstrigo. ...
Posted by Michael Wonder on 21 Sep 2019
CHMP recommends approval of Dupixent (dupilumab) for severe chronic rhinosinusitis with nasal polyposis
20 September 2019 - The EMA’s CHMP has adopted a positive opinion for Dupixent®(dupilumab) in a third indication. ...
Posted by Michael Wonder on 21 Sep 2019
FDA approves first oral GLP-1 treatment for type 2 diabetes
20 September 2019 - The U.S. FDA today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult ...
Posted by Michael Wonder on 21 Sep 2019
Astellas receives positive CHMP opinion for Xospata (gilteritinib) as a monotherapy for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation
20 September 2019 - If approved by the European Commission, gilteritinib would represent one of the few advances in Europe for ...
Posted by Michael Wonder on 21 Sep 2019
CHMP adopts positive opinion for Bavencio (avelumab) plus axitinib for first-line treatment of patients with advanced renal cell carcinoma
20 September 2019 - Opinion based on Phase III data showing combination lowered risk of disease progression or death by 31% ...
Posted by Michael Wonder on 20 Sep 2019
Highlights from the CHMP 16-19 September 2019 meeting
20 September 2019 - Seven new medicines recommended for approval. ...
Posted by Michael Wonder on 20 Sep 2019
SanBio granted regenerative medicine advanced therapy designation from the U.S. FDA for SB623 for the treatment of chronic neurological motor deficits secondary to traumatic brain injury
19 September 2019 - The SanBio Group today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation ...
Posted by Michael Wonder on 20 Sep 2019
Emmaus Life Sciences announces withdrawal of marketing authorisation application to European Medicines Agency
19 September 2019 - Emmaus Life Sciences today announced the withdrawal of its marketing authorisation application to the European Medicines ...
Posted by Michael Wonder on 19 Sep 2019
FDA continues to take steps to fulfil its commitment to strengthen and modernise the 510(k) medical device program
19 September 2019 - The U.S. FDA today announced that, as a first step toward implementation of the recently established Safety ...
Posted by Michael Wonder on 19 Sep 2019
Novartis has submitted application to EMA for approval of Cosentyx in nr-axSpA, which would be the fourth indication
17 September 2019 - 52-week data from the PREVENT study, to support FDA submission, are expected later in the year. ...
Posted by Michael Wonder on 19 Sep 2019
Flawed evidence underpins approval of new cancer drugs
18 September 2019 - We must raise the bar to ensure real benefits for patients ...
Posted 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 19 Sep 2019
FDA grants fast track designation for SPI-1005 in the treatment of Meniere's disease
18 September 2019 - Sound Pharmaceuticals is pleased to announce that the FDA's Division of Neurology Products has granted its request ...
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 ...