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.
The recent first global approval of tagraxofusp (Elzonris™) 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 2018, tagraxofusp, developed by Stemline Therapeutics, was approved by the United States Food and Drug Administration (FDA) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and children 2 years and older. Continue reading “Tagraxofusp (Elzonris™): First Global Approval – Breakthrough therapy for BPDCN and novel CD123-targeted therapy”
The PVRMS19 was presented at the Omni Shoreham Hotel, Washington DC, January 2019. During the packed three-day event, we learned that many aspect governing the development and subsequent safe and effective use of medicines are in a state of flux… and so they should be. As we learn by our actions (triumphs and failures) we make adjustments to enhance the future investigations and create medicinal agents that are effective and safe, or more precisely, have a benefit that outweighs the risks. Continue reading “Planning and strategizing in the face of evolving regulatory guidelines: Report from the DIA Pharmacovigilance and Risk Management Strategies Conference (PVRMS19)”
New study shows how drug manufacturers can reduce wastage, and therefore their costs, by altering the size of the vials they produce
Heidelberg | New York, 5 December 2018
Pharmaceuticals are often dosed according to patient weight or body size which means that a dose must be individually measured. In a new study, lead author Anthony Hatswell of Delta Hat Limited and University College London in the UK, shows that by optimizing drug dose sizes available, wastage can be cut by as much as 50 per cent. The research is in the Adis journal Applied Health Economics and Health Policy, which is published by Springer Nature.
Many pharmaceuticals, such as drugs used for cancer treatment, are only available in standard quantities, for example in 100 milligram packages. In this study, Hatswell and his co-author Joshua Porter investigated how the quantity of medicine in each package could be varied to reduce the overall wastage. This would allow manufacturers to cut their costs, helping to make medicines available to patients.
To calculate the level of wastage, the authors looked at statistics from the Health Survey for England, which gives data on the height and weight of over 5000 individuals. Using this data they calculated how much drug would be wasted at every combination of vial sizes. The analysis was then tailored to the characteristics of patients with the disease (for example, males are heavier and taller than females on average), before the total wastage was aggregated over the population. By looking at all possible combinations of package sizes, Hatswell and Porter were then able to find those with low levels of wastage. The steps laid out in the publication can therefore be applied to any drug that does not have a fixed dose.
The researchers found that wastage from the cancer drug pembrolizumab (Keytruda®, Merck, which is on track for sales of more than $5 billion in 2018) could be cut from 13.3 per cent to 8.7 per cent. Similarly the prostate cancer drug cabazitaxel (Jevtana®, Sanofi) could see wastage cut from a projected 19.4 per cent to 6.5 per cent.
“We use methods such as integer programming and operations research which date back to the Second World War and are widely used in the manufacturing of consumer goods. Their application to healthcare represents a novel step which ultimately we hope will help patients access important new medicines,” explains Hatswell.
Reference: Hatswell & Porter (2018). Reducing drug wastage in pharmaceuticals dosed by weight or body surface areas by optimising vial sizes, Applied Health Economics and Health Policy DOI: 10.1007/s40258-018-0444-0