Clinical Trials

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

Trials start for Equillium drug for autoimmune disease after India approval

Equillium secured exclusive rights to develop and commercialise itolizumab for the US and Canada markets, in May 2017.

AstraZeneca sets up clinical data and insights division in India

Drug firm AstraZeneca on Wednesday said it has launched a clinical data and insights division in India for data-related management of its clinical trials. The Bengaluru-based clinical data and insights (CDI) division is a critical advancement to support a growing global portfolio and build on internal data expertise, the drug firm said in a statement. The CDI division works across therapy areas and portfolios, supporting early and late-stage clinical programmes from Phase 1 to Phase 3, with an integrated end-to-end approach for clinical data, analytics, insights and risk management, it added. Currently, a 30-member team, the division is expected to grow to over 100 members by 2022, the drug firm said. "India has seen a constant uptick in investment in areas such as business services, engineering, digital, IT, R&D and product development from global Fortune-500 companies. AstraZeneca in India is no different since its inception, AstraZeneca India has supported the global ...

UK to offer new Covid-19 vaccine shots to Novavax trial volunteers

Around 15,000 people in the UK got Novavax shots as part of a clinical trial. While the UK recognizes them as vaccinated, most countries don't, meaning they can't travel

Pfizer vaccine safe for children aged 5-11, show clinical trial results

Pfizer said Monday its Covid-19 vaccine works for children ages 5 to 11 and that it will seek US authorisation for this age group soon -- a key step toward beginning vaccinations for youngsters.

Gennova's mRNA vaccine to come in powder form; will stay stable at 2-8 °C

The lyophilized vaccine will come in a powder form and it will be mixed with diluents before administration

DCGI nod to phase-I clinical trial of Reliance Life Sciences' Covid vaccine

DCGI on Friday granted permission to the Mukesh Ambani-owned Reliance Life Sciences to conduct phase-I clinical trial of its indigenous COVID-19 vaccine with certain conditions, sources said.

UK vaccine advisers decide against Covid vaccine for ages between 12-15 yrs

The UK's Chief Medical Officers will provide further advice on Covid-19 vaccination of young people aged between 12 to 15 years

Johnson & Johnson seeks nod for Covid vaccine trial on adolescents

To achieve herd immunity, studies have to be done on children, pharma major says

Cumulative Covid-19 vaccine doses administered in India exceed 528.9 mn

The cumulative Covid-19 vaccine doses administered in the country has exceeded 52.89 crore, the Union health ministry said on Thursday.

Covid-19 vaccine doses administered in India cross 510 mn: Health min

The cumulative COVID-19 vaccine doses administered in the country has crossed the landmark of 51 crore, the Union health ministry said on Monday. More than 49 lakh (49,06,273) doses have been administered on Monday, according to the 7 pm provisional report. The ministry said 26,66,611 vaccine doses were administered as first dose and 4,59,352 vaccine doses given as second dose in the age group 18-44 years on Monday. Cumulatively, 17,95,70,348 persons in the age group 18-44 years across all states and union territories have received their first dose and 1,24,91,475 have received their second dose since the start of the third phase of the vaccination drive. Five states -- Madhya Pradesh, Gujarat, Rajasthan, Maharashtra and Uttar Pradesh -- have administered more than 1 crore cumulative doses of COVID-19 vaccine in the age group 18-44 years. Also, Andhra Pradesh, Assam, Chhattisgarh, Delhi, Haryana, Jharkhand, Kerala, Telangana, Himachal Pradesh, Odisha, Punjab, Uttarakhand and West

SC notice to Centre, others on plea seeking data on Covid vaccine trials

The Supreme Court on Monday sought responses from the Centre and others on a plea seeking directions for disclosure of data regarding clinical trials of Covid-19 vaccines.