Join us for a live webinar at the end of March to discuss “The new E2B R3 – Challenges and considerations.” Continue reading “Webinar on the new E2B R3 – Challenges and considerations”
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”
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”
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. Continue reading “Durvalumab (IMFENZI®): Follow up Approval for NSCLC, a second indication, in USA”
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.  Continue reading “Benralizumab (Fasenra™): First Global Approval – eosinophil depletion and a convenient maintenance regimen for patients with severe asthma.”
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, based on the development milestones tracked in AdisInsight.
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. 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. Continue reading “Netarsudil (Rhopressa®): First Global Approval – New MOA ready to ROCK the world of patients with Glaucoma”
According to the Kyoto Encyclopedia of Genes and Genomes (KEGG), inotozumab ozogamicin (Besponsa®), developed by Pfizer, was also approved in Japan in January 2018. Continue reading “Inotuzumab ozogamicin (Besponsa®): Follow up Approval in Japan”