Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine

Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine

Erenumab (AIMOVIG™, erenumab-aooe) was launched in the US in July 2018, following its first global approval in the region in May, which was reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Also in May 2018, the agent received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). Continue reading “Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine”

Midostaurin (Rydapt®): First Global Approval – Double Trap shots on target for FLT3-mutated AML and Advanced SM

Midostaurin (Rydapt®): First Global Approval – Double Trap shots on target for FLT3-mutated AML and Advanced SM

The recent first (double) global approval of midostaurin 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 “Midostaurin (Rydapt®): First Global Approval – Double Trap shots on target for FLT3-mutated AML and Advanced SM”

Ribociclib (Kisqali®): First Global Approval – next-gen cyclin-dependent kinase inhibitors a new standard of care for women with advanced breast cancer

Ribociclib (Kisqali®): First Global Approval – next-gen cyclin-dependent kinase inhibitors a new standard of care for women with advanced breast cancer

The recent first global approval of ribociclib 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 “Ribociclib (Kisqali®): First Global Approval – next-gen cyclin-dependent kinase inhibitors a new standard of care for women with advanced breast cancer”

Meeting report: 3rd Annual Risk Management and Pharmacovigilance Summit, Vienna

Meeting report: 3rd Annual Risk Management and Pharmacovigilance Summit, Vienna

Colleagues from SpringerNature recently took part in the 3rd Annual Risk Management and Pharmacovigilance summit in Vienna, with the following meeting report provided by Daniela Ranzani, Adis Business Intelligence Product Manager.

Traditional topics as well as best practice and case-study presentations remain at the core of the meeting, allowing attendees to share knowledge and diverse experiences. Regulation revisions were also discussed, with a spotlight on the GVP Modules V and IX updates. Attention to patients with dedicated programs was highlighted, and a presentation on social media listening reminded us all of the great power represented by such tools when used for PV, which also brings great challenges in terms of carefully managing this type of information. Continue reading “Meeting report: 3rd Annual Risk Management and Pharmacovigilance Summit, Vienna”