After many years of planning, on 22nd November 2017 the EMA’s EudraVigilance system started accepting ICSRs submissions in the E2B R3 format. This was one amongst many changes made to EudraVigilance on this date, but implementation of R3 is certainly one of the most significant milestones. The switch from R2 to R3 is not simply a technical format change, but has potential upstream and downstream effects on case processing and other PV activities. Although there will be expected challenges in transitioning to a new ICSR format, there may also be unexpected benefits. Continue reading “E2B R3: the countdown is over”
Following on from the recent first global approval of midostaurin in the US, in December 2017, midostaurin (Rydapt™), developed by Novartis Pharmaceuticals, was also approved in Canada for FLT3 mutated acute myeloid leukemia (AML). Continue reading “Midostaurin (Rydapt™): Follow up Approval in Canada”
Following on from the first global approval of dupilumab in the US and the subsequent follow-up approval in the EU, dupilumab (Dupixant®), developed by Sanofi and Regeneron was approved by Health Canada in early December 2017 Continue reading “Dupilumab (Dupixant®): Now available in Canada”
The recent first global approval of acalabrutinib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight.
In October 2017, acalabrutinib (Calquence®), developed by Acerta Pharma, received its first global approval in the US for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Continue reading “Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma”
The first global approval of guselkumab in the USA has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.
Continue reading “Guselkumab (Tremfya™): Follow up Approval in Canada”
“The first thing you feel when a trial fails is a sense of shame,” says physician Siddhartha Mukherjee. Then comes the “exhilarating — and dangerous” instinct to slice and dice the data to resurrect the drug’s potential.
Here Siddartha discusses the lure to make more of the science than is perhaps there, when stakes are high and we are desperate to find hope for patients who are out of treatment options. Continue reading “When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results”
In September 2017, sarilumab (Kavzara™) was also approved in Japan for the treatment of adult patients with rheumatoid arthritis who have had an inadequate response to conventional treatments.
This approval is in addition to those already granted earlier this year in the US and Europe.