In March 2019, the small molecule brexanolone was approved by the United States Food and Drug Administration (FDA) for the treatment of postpartum depression (PPD) in adult women. Brexanolone, developed by Sage Therapeutics under a license from the University of California, was granted priority review status and breakthrough therapy designation by the FDA. Continue reading “Brexanolone (Zulresso™): First Global Approval – First approved therapy for postpartum depression”
I recently attended the 7th DIA India Pharmacovigilance (PV) Conference in Mumbai. One of the sessions was dedicated to the Impact of Artificial Intelligence (AI) and Predictive Sciences in the world of PV. The session was moderated by Moin Don and Anju Agarwal; the panel comprised Mengesh Kulkarni, Saikat Biswas, Retesh Kumar and Saurahb Khurana.
The interaction between the panel of guest speakers and the open floor reminded me of the Mumbai traffic: it was frenetic, loud, comprised of many different thought vehicles and yet despite all this – it traveled in the same direction without any head-on collisions! Continue reading “Artificial Intelligence: organised chaos or chaos ordered?”
It is likely that in one’s lifetime a friend or family member will be diagnosed with Alzheimer’s disease. As of 2018, approximately 50 million people worldwide are living with dementia and this number is expected to triple to 152 million by 2050.
Despite the increasing prevalence of the disease, no new drugs have been approved for the treatment of Alzheimer’s since 2003. An article recently published on PharmaTimes proclaims, “The search for a cure for Alzheimer’s is far from over.”
This first session of the conference, chaired by J Vijay Venkatraman, gave the audience a broad overview of the state of flux in pharmacovigilance, essentially resulting from changes initiated in Europe – the impact of evolving Eudrovigilance, Brexit and E2B R3 were the focal points. Continue reading “DIA India 2019: Regulatory Trends in Clinical Safety & Pharmacovigilance (An EU perspective).”
It may not have been his outright intention, but Dr Y.K. Gupta certainly set the scene and piqued the interest of the eager audience ready to receive information regarding multiple aspects of pharmacovigilance that would be lively debated throughout the following two days. Continue reading “DIA India 2019 – Keynote Presentation: India Implements Initiatives to Encourage Domestic Clinical Trial Activity and Increase Safety”
The theme for this SEVENTH Indian conference was…
“transforming clinical safety and pharmacovigilance”
In December 2018, roxadustat, developed by FibroGen, in collaboration with Astellas and AstraZeneca, received its first global approval in China for the treatment of anaemia in patients with dialysis-dependent chronic kidney disease (DD-CKD). Roxadustat is expected to launch in China in the second half of 2019.