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
A new deal protects Australians chemists at the expense of patients
22 September 2019 - Australia’s 3000 pharmacy owners have a government guaranteed monopoly that is pushing up medicine prices and the ...
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
Humana CEO: competition and innovation lower drug prices better than just putting a cap on them
20 September 2019 - U.S. lawmakers should also include in their proposals rules that would facilitate greater competition and innovation, Humana ...
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
Addition of Kisqali to drug plan in Quebec expands access to treatment for metastatic breast cancer
19 September 2019 - Provincial reimbursement provides public access to treatment that may delay the progression of advanced breast cancer. ...
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 20 Sep 2019
How an 'International Price Index' might help reduce drug prices
19 September 2019 - In gridlocked Washington, both Democrats and Republicans have signalled there's potential for a deal when it ...
Posted by Michael Wonder on 19 Sep 2019
5 people setting EU drug prices
19 September 2019 - Politic’s guide to the policy makers debating how to calculate the cost of cures. ...
Posted by Michael Wonder on 19 Sep 2019
McConnell warns Pelosi's drug pricing plan is DOA
19 September 2019 - Senate Republicans are warning Speaker Nancy Pelosi that her much-anticipated drug pricing plan is dead and ...
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. ...