ABLE, a biotech industry lobby group formed in 2003, in its report noted that the Indian bioeconomy has crossed $42 billion in 2017 and biotechnology industry is valued at $19 billion. Contrary to this, India Brand Equity Foundation (IBEF), in…
CDSCO puts Wockhardt, two others under scanner for selling drug without clearances
The CDSCO looks to give show case notices along with cancelling their licenses for the offence. These companies were apparently selling combination drugs to treat diabetes and fungal infections without the required approval. The Central Drug Standards Control Organisation (CDSCO)…
Eliminating Silos: Dismantling the Frankenstein of Clinical R&D
In 2001 there were 1,198 pharmaceutical organizations with a total of 5,995 drugs in the pipeline; as of January 2017, Pharmaprojects reports those numbers rose to 4,003 pharmaceutical companies with nearly 15,000 drugs in the pipeline. Sponsors and trials are…
Clinical Monitor Turnover Rates, Salaries Continue to Climb
Clinical research associates/monitors outside the United States don’t appear to be very happy in their jobs. According to a new “niche” survey from HR+Survey Solutions, international employee turnover in this job category leapt to nearly 23% in 2016. That’s up…
Government puts up National Rare Disease Policy in place; allocates Rs 100 crore towards genetic disorders
Rare diseases, which are often referred to as orphan diseases, are estimated to have impacted 72-96 million people in India. The Indian government has now put a National Rare Disease Policy in place and Rs 100 crore funds have been…
Pain Points for Clinical Trials Sites Abound In Systems And Devices
Clinical trial sponsors often rave about the data they collect from mobile devices, and visionaries wax poetic about the ways these datasets—combined with artificial intelligence and machine learning—will change medicine. But along the way clinical trial sites are drowning in…
Janssen’s psoriasis biologic Tremfya shows long-term effect
Top-line trial data unveiled by Janssen at the 2018 American Academy of Dermatology (AAD) Annual Meeting over the weekend indicate that the benefit of Tremfya in patients with severe plaque psoriasis is maintained in the long-term. The company said that…
Groundbreaking lung cancer approval a big boost for AZ’s Imfinzi
AstraZeneca’s immunotherapy Imfinzi has gained US approval in an important new earlier treatment setting for lung cancer patients. The company announced on Friday that the FDA had approved the drug’s use in patients with unresectable Stage III non-small cell lung…
Clinical trials: collaboration is the secret to successful outsourcing
Bringing new products to market in the era of outsourced clinical trials is reliant on the ability of sponsors and CROs to work together. The increasing globalisation of R&D has led to a rise in clinical outsourcing, as pharmaceutical companies…
Four digital trends in global clinical trials
Could ‘digital health’ be the next worldwide phenomenon? As advanced technology continues to evolve for health information purposes, it’s important to understand what digital health is and how its adoption is likely to impact end users. Digital health encompasses a…
