Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine

Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine

Erenumab (AIMOVIG™, erenumab-aooe) was launched in the US in July 2018, following its first global approval in the region in May, which was reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Also in May 2018, the agent received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). Continue reading “Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine”

FDA to revisit guidelines for biosimilar development pathway

FDA to revisit guidelines for biosimilar development pathway

In September 2017, the US FDA made public a draft industry guideline entitled “Statistical Approaches to Evaluate Analytical Similarity.”[1]  Its aim was to provide advice, to sponsors developing biosimilar agents, on how to demonstrate that the product under investigation is “highly similar” to the referenced biological. After taking into consideration the public comments relating to the document, the FDA withdrew the guideline in June 2018 for further evaluation and development to ensure that the scientific and regulatory issues that had been raised would be appropriately addressed.[2] Continue reading “FDA to revisit guidelines for biosimilar development pathway”

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”

Naldemedine (Symproic®): First Global Approval – new therapeutic option for sufferers of opioid-induced constipation

Naldemedine (Symproic®): First Global Approval – new therapeutic option for sufferers of opioid-induced constipation

The recent first global approval of naldemedine 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 “Naldemedine (Symproic®): First Global Approval – new therapeutic option for sufferers of opioid-induced constipation”

Ribociclib (Kisqali®): First Global Approval – next-gen cyclin-dependent kinase inhibitors a new standard of care for women with advanced breast cancer

Ribociclib (Kisqali®): First Global Approval – next-gen cyclin-dependent kinase inhibitors a new standard of care for women with advanced breast cancer

The recent first global approval of ribociclib 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 “Ribociclib (Kisqali®): First Global Approval – next-gen cyclin-dependent kinase inhibitors a new standard of care for women with advanced breast cancer”

Telotristat Ethyl (Xermelo™): First Global Approval – first and only oral drug for cancer-related diarrhoea syndrome

Telotristat Ethyl (Xermelo™): First Global Approval – first and only oral drug for cancer-related diarrhoea syndrome

The recent first global approval of telotristat ethyl 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 “Telotristat Ethyl (Xermelo™): First Global Approval – first and only oral drug for cancer-related diarrhoea syndrome”

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”