Baricitinib (Olumiant™): Now also available in the USA

Baricitinib (Olumiant™): Now also available in the USA

Baricitinib was first approved in the EU in February 2017 for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA);[1] this was followed shortly after by an approval in Japan in July of the same year.[2] Almost a year later, this Janus Kinase (JAK) inhibitor was approved by the US FDA in June 2018.[3] Continue reading “Baricitinib (Olumiant™): Now also available in the USA”

Ibalizumab (Trogarzo™): First Global Approval – Blocking HIV entry to CD4 cells may open options for combination therapy in patients with multi-resistant HIV infection

Ibalizumab (Trogarzo™): First Global Approval – Blocking HIV entry to CD4 cells may open options for combination therapy in patients with multi-resistant HIV infection

The recent first global approval of Ibalizumab 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].

Ibalizumab (Trogarzo™) developed by TaiMed Biologics received its first global approval in March 2018 in the US for the treatment of heavily treatment-experienced patients with multidrug resistant HIV-1 infection in combination with other antiretroviral medicines. Continue reading “Ibalizumab (Trogarzo™): First Global Approval – Blocking HIV entry to CD4 cells may open options for combination therapy in patients with multi-resistant HIV infection”

Burosumab (Crysvita®): First Global Approval – Infrastructure repair for patients with X-linked hypophosphataemia

Burosumab (Crysvita®): First Global Approval – Infrastructure repair for patients with X-linked hypophosphataemia

The recent first global approval of burosumab 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 “Burosumab (Crysvita®): First Global Approval – Infrastructure repair for patients with X-linked hypophosphataemia”

Revolution, innovation, and collaboration: report from the World Drug Safety Congress

Revolution, innovation, and collaboration: report from the World Drug Safety Congress

Although automation and artificial intelligence were yet again some of the buzz words at this pharmacovigilance conference, I was even more interested to hear other perspectives on how the industry is changing and what initiatives are being implemented in order to adapt to this environment. The World Drug Safety Congress US took place in Philadelphia on 10-11 April with over 350 attendees and over 100 speakers. Continue reading “Revolution, innovation, and collaboration: report from the World Drug Safety Congress”

Apalutamide (Erleada™): First Global Approval – Reduces risk of metastasis in patients with non-metastatic, castration-resistant prostate cancer

Apalutamide (Erleada™): First Global Approval – Reduces risk of metastasis in patients with non-metastatic, castration-resistant prostate cancer

The recent first global approval of Apalutamide 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 mid-February 2018, apalutamide (Erleada™), developed by Janssen, received its first global approval in the US for the treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC). Continue reading “Apalutamide (Erleada™): First Global Approval – Reduces risk of metastasis in patients with non-metastatic, castration-resistant prostate cancer”

Bictegravir (Biktarvy®): First Global Approval – an all-in-one package: A single-tablet HIV-1 treatment regimen

Bictegravir (Biktarvy®): First Global Approval – an all-in-one package: A single-tablet HIV-1 treatment regimen

The recent first global approval of bictegravir 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].

Bictegravir (Biktarvy®), developed by Gilead Sciences, received its first global approval in February 2018 in the USA as a fixed-dose combination, with emtricitabine and tenofovir alafenamide. Continue reading “Bictegravir (Biktarvy®): First Global Approval – an all-in-one package: A single-tablet HIV-1 treatment regimen”

Ertugliflozin (Steglatro™): First Global Approval – followed swiftly by FDCs in US and EU… good news for patients with type-two diabetes mellitus

Ertugliflozin (Steglatro™): First Global Approval – followed swiftly by FDCs in US and EU… good news for patients with type-two diabetes mellitus

In December 2017, ertugliflozin (Steglatro™), developed by Merck and Pfizer, received its first global approval in the US for use in conjunction with exercise and diet to improve glycaemic control in adults with type-2 diabetes mellitus (T2DM). [1 Continue reading “Ertugliflozin (Steglatro™): First Global Approval – followed swiftly by FDCs in US and EU… good news for patients with type-two diabetes mellitus”

Durvalumab (IMFENZI®): Follow up Approval for NSCLC, a second indication, in USA

Durvalumab (IMFENZI®): Follow up Approval for NSCLC, a second indication, in USA

In February 2018, durvalumab (IMFENZI®) was approved in the US for the treatment of patients with unresectable, stage III non-small cell lung cancer (NSCLC), whose cancer has not progressed after chemoradiation therapy.[1] Continue reading “Durvalumab (IMFENZI®): Follow up Approval for NSCLC, a second indication, in USA”

Benralizumab (Fasenra™): First Global Approval – eosinophil depletion and a convenient maintenance regimen for patients with severe asthma.

Benralizumab (Fasenra™): First Global Approval – eosinophil depletion and a convenient maintenance regimen for patients with severe asthma.

In November 2017, benralizumab (Fasenra™), developed by Kyowa Hakka Kirin & AstraZeneca, received its first global approval in the USA as add-on maintenance therapy for patients with severe eosinophilic asthma who are at least 12 years old. [1][2] Continue reading “Benralizumab (Fasenra™): First Global Approval – eosinophil depletion and a convenient maintenance regimen for patients with severe asthma.”

Netarsudil (Rhopressa®): First Global Approval – New MOA ready to ROCK the world of patients with Glaucoma

Netarsudil (Rhopressa®): First Global Approval – New MOA ready to ROCK the world of patients with Glaucoma

The recent first global approval of netarsudil ophthalmic solution 0.02% 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 December 2017 netarsudil (Rhopressa®), developed by Aerie Pharmaceuticals, received its first global approval in the US for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.[3] Interestingly, this approval was made two months in advance of the official scheduled Prescription Drug User Fee Act (PDUFA) goal date of 28th February 2018.[4] Continue reading “Netarsudil (Rhopressa®): First Global Approval – New MOA ready to ROCK the world of patients with Glaucoma”