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”

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

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

In February 2018, durvalumab (IMFINZI®) 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 (IMFINZI®): Follow up Approval for NSCLC, a second indication, in USA”

Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma

Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell lymphoma

The recent first global approval of acalabrutinib 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 October 2017, acalabrutinib (Calquence®), developed by Acerta Pharma, received its first global approval in the US for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Continue reading “Acalabrutinib (Calquence®): First Global Approval – Downstream approach dams the ability for tumour-survival in patients with mantle cell 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”

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!!”

Cerliponase Alfa (Brineura™): First Global Approval – first flicker of hope for families living with CLN2

Cerliponase Alfa (Brineura™): First Global Approval – first flicker of hope for families living with CLN2

The recent first global approval of cerliponase alfa has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight. Continue reading “Cerliponase Alfa (Brineura™): First Global Approval – first flicker of hope for families living with CLN2”

Avelumab (Bavencio®): First Global Approval – Inaugural Immunotherapy for Metastatic Merkel Cell Carcinoma

Avelumab (Bavencio®): First Global Approval – Inaugural Immunotherapy for Metastatic Merkel Cell Carcinoma

The recent first global approval of avelumab has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

Continue reading “Avelumab (Bavencio®): First Global Approval – Inaugural Immunotherapy for Metastatic Merkel Cell Carcinoma”

AdisInsight is PRIMEd

AdisInsight is PRIMEd

Adis adds PRIME status to AdisInsight drug profiles.

In 2016, the European Medicines Agency launched PRIME – a program to enhance support for the development of medicines that target an unmet medical need. This voluntary program is based on enhanced interaction and early dialogue with developers of promising medicine, to optimise development plans and speed up evaluation so that these medicines can reach patients earlier.

Continue reading “AdisInsight is PRIMEd”

Rucaparib (Rubraca™): First Global Approval – further improves personalised cancer care in high-need indication

Rucaparib (Rubraca™): First Global Approval – further improves personalised cancer care in high-need indication

The recent first global approval of rucaparib has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

In December 2016, Rucaparib (Rubraca™), developed by Clovis Oncology, Inc., received its first global approval in the USA for the treatment of ovarian cancer, specifically as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies.1 A marketing authorisation application for rucaparib for the same indication has been submitted to the European Medicines Agency. Continue reading “Rucaparib (Rubraca™): First Global Approval – further improves personalised cancer care in high-need indication”