Page 2 - Clinical Trials

India becoming attractive for clinical trials, says pharma industry leaders

Over the past 10 years, clinical trials in India have become easier, more accessible and accelerated, experts from the pharma sector have said as top multinationals are increasingly looking at the country as their base for clinical trials. Data from 2017 to 2023 shows that phase two and phase three clinical trials are growing at about 15 per cent to 18 per cent in India. This is primarily because of the 10 modifications done to the Drugs and Cosmetics Act of 1940, according to Badhri Srinivasan, head of Global Clinical Operations, Novartis. Novartis is one of the largest pharmaceutical companies in the world and was the fourth largest by revenue in 2022. Given where we are, given what the landscape in the international community has happened, the regulators in India are starting to move and make changes to it. Since 2013, there have been 10 modifications to that act to try to make clinical trials easier, more accelerated, more accessible, et cetera, Srinivasan said at the 18th Annua

Veeda Clinical Research buys European CRO Heads for an undisclosed sum

Veeda expands its footprint across major regions and will gain expertise in late-stage oncology trials

AstraZeneca to import critical drugs to India, focus on cancer therapies

AstraZeneca is currently conducting 50 clinical trials in India

IIL launches first indigenously developed Hepatitis A vaccine, 'Havisure'

Hepatitis A is a viral infection primarily spread through the fecal-oral route, meaning that it is transmitted through the ingestion of contaminated food or water

China health ministry for more fever clinics to combat mystery illness

Both SARS and Covid-19 were first reported as unusual types of pneumonia

Russia's loss can be India's gain in clinical trial shift, say experts

India's contribution to global clinical trials has been around 4 percent in the last decade while it's the second most populous country in the world, and has one-fifth of the global disease burden

'Malaysia, Korea are preferred to India as global clinical trial sites'

There is intense competition to have these studies on advanced or complex unmet medical needs in a country

R21/Matrix-M malaria vaccine: What it is, and when will it roll out?

The R21/Matrix-M malaria vaccine is an easily deployable vaccine that can be manufactured at a mass scale with a modest cost

Bharat Biotech plans to invest Rs 3,000-4,000 crore in post-Covid shift

Not thinking about an IPO as of now, says chairman

India's contribution to global clinical trials at 4% during 2010-22: Study

Trials sponsored by top 20 pharma companies increased 10% since 2013

India emerging as favourable place to conduct medical trials: PwC India

India has the potential to increase global clinical trials in the country by five times in the coming years, a report has said, with experts highlighting the significant opportunities for biopharma companies to leverage India's rich diversity and robust healthcare infrastructure to develop innovative treatments. The joint report by the USA India Chamber of Commerce & PwC India titled, Clinical Trial opportunities in India which will be released at the virtual edition of the 17th annual BioPharma & Healthcare Summit 2023 to be held on Wednesday in Boston also indicates that through several key drivers, India is emerging as a favourable destination to conduct clinical trials. According to the report, the private sector is a well-suited channel for the top biopharma to conduct more efficient clinical trials with easier and faster access to investigators and patients. According to the report, India has the potential to increase global clinical trials in the country by five times ..

Biocon starts new clinical study to evaluate efficacy of Itolizumab

Biotechnology major Biocon on Wednesday said it has initiated a clinical study in collaboration with Equillium Inc to evaluate efficacy of Itolizumab in patients with Ulcerative Colitis. This is a phase two randomised, double-blind, parallel-group, placebo and active-controlled (adalimumab), two treatment period study to evaluate the safety and efficacy of Itolizumab for the induction of remission in biologics naive patients with moderate to severely active Ulcerative Colitis (UC), Biocon said in a statement. Having obtained approval from the Drugs Controller General of India (DCGI), the study will cover several tertiary hospitals specialised in handling UC cases, it added. The first patient who intended to participate in the study was screened on December 1, 2022, the company said. "The commencement of the Phase two clinical study, that will determine its efficacy for the treatment of Ulcerative Colitis, is an important step forward in our efforts to bring its benefit to patients

Lab-grown blood in UK given to people in world-first clinical trial

Scientists in the UK have infused blood cells grown in a laboratory into people in the first such clinical trial in the world. If proven safe and effective, manufactured blood cells could in time revolutionise treatments for people with blood disorders such as sickle cell and rare blood types, the researchers said. It can be difficult to find enough well-matched donated blood for some people with these disorders, they said. The team, including researchers from the University of Cambridge in the UK, said the blood cells were grown from stem cells from donors. The red cells were then transfused into healthy volunteers. This is the first time in the world that red blood cells that have been grown in a laboratory have been given to another person as part of a trial into blood transfusion, they said. "We hope our lab grown red blood cells will last longer than those that come from blood donors," said chief investigator Cedric Ghevaert, a professor at the University of Cambridge and NHS

Intranasal Covid vaccine will be global game changer: Bharat Biotech MD

Phase III trials were conducted for safety, and immunogenicity in about 3,100 subjects, in 14 trial sites across India

Bharat Biotech's Zika vaccine to enter Phase 2 clinical trials soon

In 2016, Big Pharma companies like Pfizer, Johnson & Johnson, and Merck were evaluating developing a Zika vaccine

Govt moots regulation of e-pharmacies, trial mishap penalties in new bill

Also, for the first time, regulations for conduct of clinical trials for new drugs and medical devices have been brought under the draft New Drugs, Medical Devices and Cosmetics Bill, 2022

Pfizer stock falls as Covid pill fails in preventive therapy trial

The trial failure, along with reports of rebounding coronavirus levels in some patients who have completed a course of Paxlovid, are unlikely to change the drug's sales potential

Glenmark to conduct clinical trials of its molecule on cancer patients

Glenmark Pharmaceuticals on Monday said its unit has received approval from the DCGI to conduct phase 1 clinical trials of its novel molecule on patients with advanced solid tumors.

World's first ayush phase-3 trial for rheumatoid arthritis in India

Study will begin in May, to take two years to complete

Decision to vaccinate children 'unscientific': Senior AIIMS epidemiologist

A senior epidemiologist at AIIMS termed the Centre's decision to vaccinate children against Covid "unscientific" and said it will not yield any additional benefit