Pharmacovigilance in the Middle East: Adis PV attends the regional ISoP meeting

Pharmacovigilance in the Middle East: Adis PV attends the regional ISoP meeting

Springer Nature sponsored the annual meeting of the International Society of Pharmacovigilance (ISoP) Middle East Chapter under the Adis Pharmacovigilance brand, held on the 20th of September 2018 in Dubai. ISoP is an international non-profit organisation which aims to promote pharmacovigilance and enhance the safety and proper use of drugs worldwide. Continue reading “Pharmacovigilance in the Middle East: Adis PV attends the regional ISoP meeting”

The World Drug Safety Congress in Amsterdam addresses key challenges

The World Drug Safety Congress in Amsterdam addresses key challenges

Adis Pharmacovigilance attended the World Drug Safety Congress in Amsterdam on Sept 10th and 11th.

The event has been running for over a decade and is world renowned for its ability to connect key stakeholders in the drug safety field, as well as for leading the way in moving the sector forward.

Senior level drug safety professionals, as well as representatives from sponsors and service providers, met to discuss key topics and showcase solutions.

This year’s theme, Addressing Key Challenges for Safety Professionals, had us prepared for a series of interesting presentations and discussions on the ever growing importance of pharmacovigilance and the challenges connected with ensuring patient safety. Continue reading “The World Drug Safety Congress in Amsterdam addresses key challenges”

Call for papers: Special Issue – Family Spillover Effects of Illness

Call for papers: Special Issue – Family Spillover Effects of Illness

PharmacoEconomics invites the submission of manuscripts with a focus on family spillover effects of illness for a special issue of the journal to be published in 2018.

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Cover image of Pharmaco-Economics

The issue will focus on methods and applications for measuring spillover effects as well as conceptual papers discussing methodological and practical issues.

In a paper previously published in PharmacoEconomics, Guest Editors Eve Wittenberg and Lisa Prosser state:

Caring for an ill or disabled family member imposes a well-documented burden on the caregiver. The benefits of a health intervention may be underestimated if “spillover” effects on family members are not captured, resulting in inaccurate conclusions of economic evaluations.

For the context of this special issue, family spillover is defined as the effect on an individuals’ quality of life due to having a family member with a chronic illness. We consider spillover to include family caregivers as well as non-caregivers. Extensions to larger social networks may also be included with justification (e.g., classmates for children’s illnesses).

Topics of interest include:

  • Applications: Measurement of spillover for specific conditions or populations of interest, inclusion of spillover in cost-effectiveness analyses.
  • Methods: Conceptual frameworks, measurement tools or approaches, methodological or practical issues in measurement; challenges to application in CEA.

Please submit an abstract describing your proposed paper by July 31, 2017 to the Editor, Chris Carswell . Full papers will be invited by August 31, 2017 and manuscripts due in early 2018.

Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis

Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis

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

In February 2017, sarilumab (Kevzara™), developed by Sanofi and Regeneron Pharmaceuticals, received its first global approval in Canada for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Continue reading “Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis”

Baricitinib (Olumiant™): First Global Approval – daily oral formulation may win patient preference for next-gen RA treatment

Baricitinib (Olumiant™): First Global Approval – daily oral formulation may win patient preference for next-gen RA treatment

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

In February 2017, baricitinib (Olumiant™), developed by Eli Lily and Incyte Corporation, received its first global approval in the EU as monotherapy or in combination with methotrexate, for the treatment of moderate to severe rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Continue reading “Baricitinib (Olumiant™): First Global Approval – daily oral formulation may win patient preference for next-gen RA treatment”

Plecanatide (Trulance™): First Global Approval –new treatment option for gastrointestinal disorders

Plecanatide (Trulance™): First Global Approval –new treatment option for gastrointestinal disorders

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

Late January 2017, plecanatide (Trulance™), developed by Synergy Pharmaceuticals, received its first global approval in the USA for the treatment of adult patients with chronic idiopathic constipation (CIC). Plecanatide is an oral guanylate cyclase-C (GC-C) agonist that regulates ion and fluid transport in the gastrointestinal tract. Continue reading “Plecanatide (Trulance™): First Global Approval –new treatment option for gastrointestinal disorders”

Rucaparib (Rubraca™): First Global Approval – further improves personalised cancer care in high-need indication

Rucaparib (Rubraca™): First Global Approval – further improves personalised cancer care in high-need indication

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

In December 2016, Rucaparib (Rubraca™), developed by Clovis Oncology, Inc., received its first global approval in the USA for the treatment of ovarian cancer, specifically as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies.1 A marketing authorisation application for rucaparib for the same indication has been submitted to the European Medicines Agency. Continue reading “Rucaparib (Rubraca™): First Global Approval – further improves personalised cancer care in high-need indication”

Date announced for next safety biomarkers webinar

Date announced for next safety biomarkers webinar

The second in a two-part series of live webinars on Pharmacovigilance and Safety Biomarkers is set to take place on Tuesday, March 21, 2017.

Joining forces with Amplion, the leading biomarker business intelligence company, we aim to provide useful insights for anyone involved in R&D, product strategy decisions, or working directly in a drug safety related role.

During the webinar, our speakers will cover: Continue reading “Date announced for next safety biomarkers webinar”

Adis brings together expert speakers for special webinar on safety biomarkers

The team behind AdisInsight are working in collaboration with their latest partners, Amplion, to host a special live webinar on December 13, 2016, on the topic “Pharmacovigilance and Safety Biomarkers”.

Safety biomarkers offer potential benefits throughout the drug lifecycle. These range from the identification of drug candidates most likely to be tolerated in humans, through to predictive identification of patients most likely to benefit from, or not be harmed by, a treatment.

The webinar will provide an introduction to biomarkers, their characteristics, and current uses in drug safety. Information presented will be of interest to those working in pharmaceutical/biotechnology industries and adjacent markets – including those working in R&D, making strategic decisions, or directly involved in drug safety.

Guest speakers for the session include Nitin Joshi, Editor of Drug Safety – the official journal of the International Society of Pharmacovigilance (ISoP), which is published by Adis.

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Speaker profiles

Registration is free and open to all via the information page: http://www.springer.com/gp/adis/pharmacovigilance-and-safety-biomarkers

The December session will be the first in a two-part series on this topic, the second part of which will be held in late January 2017.