Semaglutide (Ozempic®): First Global Approval – Plus rapid follow-ups in major markets – will this once-weekly prefilled pen write the future for convenience in patients with type 2 Diabetes Mellitus?

Semaglutide (Ozempic®): First Global Approval – Plus rapid follow-ups in major markets – will this once-weekly prefilled pen write the future for convenience in patients with type 2 Diabetes Mellitus?

On December 5th 2017, semaglutide (Ozempic®), developed by Novo Nordisk, received its first global approval in the US.[1] Nine days later the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in the EU.[2] This was followed swiftly by Health Canada’s approval in January 2018.[3] [4] In all cases, semaglutide was approved for use in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise to improve glycaemic control. The drug is dispensed as prefilled pens for subcutaneous injection once weekly. Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner.[3] It is administered on the same day each week, at any time and without regard for food intake.[1] Continue reading “Semaglutide (Ozempic®): First Global Approval – Plus rapid follow-ups in major markets – will this once-weekly prefilled pen write the future for convenience in patients with type 2 Diabetes Mellitus?”

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”

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”

Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer

Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer

The recent first global approval of abemaciclib 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 “Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer”

1998 Shirov: Bishop to h3! Dubbed an all-time strategic chess move… How do future pharmacovigilance strategies compare?

1998 Shirov: Bishop to h3! Dubbed an all-time strategic chess move… How do future pharmacovigilance strategies compare?

Report: Pharmacovigilance Strategy Meeting, Boston, MA, USA November 2017

In less time than it took for me to travel to the meeting from New Zealand – the day was over! Hard to believe that within a short eight hours, 25 lively roundtables were conducted, two keynote speeches were delivered, and the panel discussed the learning of the day, including challenges of monitoring diverse sources, importance of real-world evidence in the context of risk benefit, and the game-changing impact of artificial intelligence. Continue reading “1998 Shirov: Bishop to h3! Dubbed an all-time strategic chess move… How do future pharmacovigilance strategies compare?”

Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!

Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!

The recent first global approval of glecaprevir/pibrentasvir 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 “Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!”

Enasidenib (Idhifa®): First Global Approval – first-in-class, precision therapy for patients with mutated AML

Enasidenib (Idhifa®): First Global Approval – first-in-class, precision therapy for patients with mutated AML

The recent first global approval of enasidenib 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 “Enasidenib (Idhifa®): First Global Approval – first-in-class, precision therapy for patients with mutated AML”

Neratinib (Nerlynx™): First Global Approval – a new adjuvant option for HER2+ve breast cancer patients – but has it bottomed out before it’s begun?

Neratinib (Nerlynx™): First Global Approval – a new adjuvant option for HER2+ve breast cancer patients – but has it bottomed out before it’s begun?

The recent first global approval of neratinib 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 “Neratinib (Nerlynx™): First Global Approval – a new adjuvant option for HER2+ve breast cancer patients – but has it bottomed out before it’s begun?”

Guselkumab (Tremfya™): First Global Approval – first-in-class biologic treatment option for adult plaque psoriasis

Guselkumab (Tremfya™): First Global Approval – first-in-class biologic treatment option for adult plaque psoriasis

The recent first global approval of guselkumab 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 “Guselkumab (Tremfya™): First Global Approval – first-in-class biologic treatment option for adult plaque psoriasis”