Data Integrity Issue Haunts Again With Covid Vaccine?

On March 22, 2021, by a media release, AstraZeneca announced that its ‘US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% in preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization.’ Quite unexpectedly, on March … Continue reading

Any Threat To Current Commercial Model Of ‘Gene Therapy’?

Wish All My Readers A Very Happy, Healthy, Peaceful and Prosperous 2020   One of the most complex areas in disease management, is the ailments related to genetic disorders. As these were incurable, over the last four decades, medical researchers … Continue reading

On The Flip Side of Pharma Industry: A Saga of Perennial Contradictions

Awesome contribution in the battle against multiple diseases, is obviously the primary facet of the pharma industry. However, on its flip side, one would witness a saga of numerous contradictions. Some of these exist perennially in well-protected opaque cocoons, regardless … Continue reading

A New Facet of ‘Data Integrity’ With Novel Therapy… And Much Beyond

The peril of breach of data integrity involving a top Indian pharma player, jolted many, probably for the first time, on September 17, 2008. On that day, the USFDA, reportedly, issued two ‘Warning Letters’ and an ‘Import Alert’. These were related to … Continue reading

Gene Therapy Price: Commercial Viability And Moral Dilemma

On May 24, 2019, Novartis announced the US-FDA approval of ‘the first and only gene therapy’ – Zolgensma, for a type of Spinal Muscular Atrophy (SMA), a lifesaving treatment for infants of less than 2 years of age. This unique drug halts disease progression … Continue reading

A Disruptive Innovation to Fight and Cure Intractable Diseases

Several important facets of health care often arrest general attention. These are also widely discussed, analyzed and argued vehemently – with each person or group trying to justify one’s own point of view. Among these, following 6 critical areas, broadly … Continue reading

An Evolving Paradigm of ‘Price-Value Model’ Of Pharma Value Delivery System

May 4, 2016 edition of the ‘MIT Technology Review’ published an interesting article carrying the headline, “The World’s Most Expensive Medicine Is a Bust”. The obvious question that floats at the top of mind: What is this most expensive drug … Continue reading

Cancer Cure: Inching Towards The ‘Holy Grail’?

In a Press Conference on August 20, 2015, the 39th President of the United States, now 90-year-old  Jimmy Carter, revealed (video) that during a liver surgery earlier this month the doctors diagnosed that he has cancer. The type of cancer that he … Continue reading