The USFDA defines real-world data (RWD) as ‘the data relating to patient health status and/or the healthcare delivery that is routinely collected from a variety of sources’, and real-world evidence (RWE) as ‘the clinical evidence regarding the usage and potential risks/benefits of a medical product obtained from analysis of RWD.’[1] RWD includes data from electronic […]
Drug prices in the US are the highest in the world, which necessitate new or alternate payment approaches. For instance, the new treatments for hepatitis C virus (HCV) infection are highly effective and very expensive at the same time, at least from the view of many payers, physicians, and patients. Even 5 years after these […]
Traditionally, the pharmaceutical industry has always been dependent upon the ‘push’ strategy for successful market access for products. The drug approval process, involving submission of data on efficacy, safety, and tolerability to the regulatory agencies, used to be simple; which ended with the drug being marketed to the targeted physicians and dispensed by pharmacies post approval. Thus, this whole process involved a limited set of stakeholders, viz. physicians, regulatory agencies, and pharmacies.
Traditionally, the pharmaceutical industry has always been dependent upon the ‘push’ strategy for successful market access for products. The drug approval process, involving submission of data on efficacy, safety, and tolerability to the regulatory agencies, used to be simple; which ended with the drug being marketed to the targeted physicians and dispensed by pharmacies post approval. Thus, […]
Every country exercises strict control on medicines’ market access. Typically, this requires successful completion and adequate presentation of results from phase I through phase III clinical trials, bringing forward the findings of medicine’s safety and efficacy. The USFDA approves approximately 40 new medicines for the US market each year through this process. (1) In India, […]
The biologics market is rapidly growing, at almost twice the rate of pharma industry. Estimates are such that 7 of the top 10 global medicines by spending will be a biologic within the next 5 years. To add to this, a new class of biologics, known as “biobetters”, is being introduced that could compete with […]
We all want safe and effective medicines to reach patients as soon as possible, but as we know, drug development, market authorization and payer assessment are all slow sections of a long and drawn out journey for a drug. But what if patients could have access to medicines not just months earlier, but potentially 8 […]
