Bictegravir (Biktarvy®): Positive CHMP Opinion in the EU

Bictegravir (Biktarvy®): Positive CHMP Opinion in the EU

Bictegravir, in combination with emtricitabine and alafenamide (Biktarvy ®) received its first global approval in the US in February 2018.[1] Subsequently, in April, this fixed-dose triple combination has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA).[2] Continue reading “Bictegravir (Biktarvy®): Positive CHMP Opinion in the EU”

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”

Baloxavir Marboxil (XOFLUZA™): First Global Approval – a One-Pill Wonder for Patients with Influenza

Baloxavir Marboxil (XOFLUZA™): First Global Approval – a One-Pill Wonder for Patients with Influenza

The recent first global approval of baloxavir marboxil 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].

Japan was first country to approve baloxavir marboxil (XOFLUZA™) in February 2018, under Sakigake fast track review. The agent is being jointly developed by Shionogi and Roche and was approved for the treatment of influenza types A and B in paediatric and adult patients. Continue reading “Baloxavir Marboxil (XOFLUZA™): First Global Approval – a One-Pill Wonder for Patients with Influenza”

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”

Using state-of-the-art technology to combat challenges unique to 21st century culture

Using state-of-the-art technology to combat challenges unique to 21st century culture

Since I now have a piqued interest in the application of artificial intelligence in pharmacovigilance, I was interested to read the findings from a study using machine learning to identify ICSRs in social media.  Until now, my impression of ADRs reported in the social media was that identifying valid ICSRs was more than challenging due to their diversity, complexity, colloquialisms and anonymity. Also, it seems the regulatory authorities acknowledge these challenges as it is not yet a regulatory requirement to monitor social media as a source for ICSRs. But is this looking set to change if machine learning and automation become the norm? Continue reading “Using state-of-the-art technology to combat challenges unique to 21st century culture”

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”