Avatrombopag (Doptelet®): First Global Approval – Reducing the bleeding risks of invasive procedures in patients with Chronic Liver Disease

Avatrombopag (Doptelet®): First Global Approval – Reducing the bleeding risks of invasive procedures in patients with Chronic Liver Disease

Avatrombopag (Doptelet ®) received its first global approval in the US; this was 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 “Avatrombopag (Doptelet®): First Global Approval – Reducing the bleeding risks of invasive procedures in patients with Chronic Liver Disease”

Anlotinib (Focus V®): First Global Approval – single-drug 3rd-line therapy for patients with advanced recurrent NSCLC

Anlotinib (Focus V®): First Global Approval – single-drug  3rd-line therapy for patients with advanced recurrent NSCLC

The recent first global approval of anlotinib 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 May 2018, anlotinib (Focus V®), co-developed by Jiangsu Chia-Tai Tianqing Pharmaceutical and Advenchen Laboratories, received its first global approval in China as a single drug therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have undergone progression or recurrence after ≥ 2 lines of systemic chemotherapy.  Continue reading “Anlotinib (Focus V®): First Global Approval – single-drug 3rd-line therapy for patients with advanced recurrent NSCLC”

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”

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”

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”

Elsulfavirine (Elpida®): First Global Approval – a potential aid to the HIV epidemic in Russia

Elsulfavirine (Elpida®): First Global Approval – a potential aid to the HIV epidemic in Russia

The recent first global approval of elsulfavirine 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 “Elsulfavirine (Elpida®): First Global Approval – a potential aid to the HIV epidemic in Russia”

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?”

Delafloxacin (Baxdela™): First Global Approval – Flexible dosing, broad spectrum coverage, effective against resistant pathogens – appealing characteristics for the treatment of ABSSSI

Delafloxacin (Baxdela™): First Global Approval – Flexible dosing, broad spectrum coverage, effective against resistant pathogens – appealing characteristics for the treatment of ABSSSI

The recent first global approval of delafloxacin 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 “Delafloxacin (Baxdela™): First Global Approval – Flexible dosing, broad spectrum coverage, effective against resistant pathogens – appealing characteristics for the treatment of ABSSSI”