The Year of the Dog: If you can’t run with the big dogs, stay on the porch

The Year of the Dog:  If you can’t run with the big dogs, stay on the porch

Report from the DIA’s Pharmacovigilance and Risk Management Strategies Conference, Washington, DC, 22-24 January 2018

Despite the US government shutdown resulting in a noticeable absence of FDA personnel, the DIA’s Pharmacovigilance and Risk Management Strategies conference was a well-attended event. The conference was hosted in Washington, DC, from 22-24th January 2018. As usual the programme was excellent, extensive and covered many hot topics; a recurring theme was how quickly some players in the PV industry are adapting to modern-day challenges including newer technologies for treatment, so-called big data, seemingly incessant social media and the rise of artificial intelligence. Continue reading “The Year of the Dog: If you can’t run with the big dogs, stay on the porch”

Neratinib (Nerlynx™): Negative opinion in the European Union

Neratinib (Nerlynx™): Negative opinion in the European Union

Neratinib was first approved in the US in July 2017.[1] However the eagerly awaited opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the future of the drug on the other side of the globe must have been disappointing for Puma Biotechnology. Continue reading “Neratinib (Nerlynx™): Negative opinion in the European Union”

Emicizumab-kxwh (Hemlibra®): First Global Approval – novel mechanism and once-weekly regimen hoped to revolutionise routine prophylaxis in patients with haemophilia A

Emicizumab-kxwh (Hemlibra®): First Global Approval – novel mechanism and once-weekly regimen hoped to revolutionise routine prophylaxis in patients with haemophilia A

The recent first global approval of emicizumab-kxwh 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 “Emicizumab-kxwh (Hemlibra®): First Global Approval – novel mechanism and once-weekly regimen hoped to revolutionise routine prophylaxis in patients with haemophilia A”

Letermovir (Prevymis™): First Global Approval – Distinct mechanism of action provides protection against CMV in recipients of HSCT

Letermovir (Prevymis™): First Global Approval – Distinct mechanism of action provides protection against CMV in recipients of HSCT

The recent first global approval of letermovir 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 “Letermovir (Prevymis™): First Global Approval – Distinct mechanism of action provides protection against CMV in recipients of HSCT”

Durvalumab (IMFINZI®): Follow up Approval in Canada

Durvalumab (IMFINZI®): Follow up Approval in Canada

The recent first global approval[1] of durvalumab in the US has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[2], based on the development milestones tracked in AdisInsight.[3]

In November, 2017, durvalumab (Imfinzi™), developed by AstraZeneca via Medimmune, was also approved in Canada for the treatment of advanced bladder cancer (late stage and/or metastatic disease) as monotherapy in previously treated patients (second-line or greater).[4] Continue reading “Durvalumab (IMFINZI®): Follow up Approval in Canada”