Month: December 2017

E2B R3: the countdown is over

E2B R3: the countdown is over

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” →

Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma

Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma

The recent first global approval of acalabrutinib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

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” →

When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results

When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results

“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” →

Sarilumab (Kevzara™): Follow up Approval in Japan

Sarilumab (Kevzara™): Follow up Approval in Japan

The first global approval of sarilumab in Canada has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

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[1].

This approval is in addition to those already granted earlier this year in the US and Europe.

For further information related to the first approval of sarilumab please visit Drugs, or to learn more about the overall development of sarilumab across all indications visit AdisInsight.

Telotristat Ethyl (Xermelo™): Follow up Approval in Europe

Telotristat Ethyl (Xermelo™): Follow up Approval in Europe

The first global approval of telotristate Ethyl 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.

In September 2017, Telotristate Ethyl (Xermelo™), developed by Lexicon Pharmaceuticals, was also approved in all 28 states of the European Union, plus Norway and Iceland for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analog therapy[1].

Kjell Oberg, M.D., Ph.D., Professor of Endocrine Oncology, Chairman Centre of Excellence Endocrine Tumors, Uppsala University Hospital, said that the approval “marks an inflection point for patients and their families in Europe who have waited a long time for a novel treatment option for carcinoid syndrome diarrhoea.” [1]

For further information related to the first approval of telotristate ethyl please visit Drugs,or to learn more about the overall development of telotristate ethyl across all indications visit AdisInsight.

Image credit:  Ivelin Radkov / Fotolia

Copanlisib (Aliqopa™): First Global Approval – First of its kind to offer hope to patients with relapsed follicular lymphoma

Copanlisib (Aliqopa™): First Global Approval – First of its kind to offer hope to patients with relapsed follicular lymphoma

The recent first global approval of copanlisib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Copanlisib (Aliqopa™): First Global Approval – First of its kind to offer hope to patients with relapsed follicular lymphoma” →