Page 2 - Clinical Trials

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.

Govt recommends nod to SII for phase 2/3 trials of Covovax on children

An expert panel of India's Central Drug Authority recommended granting permission to Serum Institute of India for conducting phase 2/3 trials of Covid vaccine Covovax on children aged 2 to 17 years

Zydus Covid-19 vaccine for children soon, Centre tells Delhi High Court

This comes as the court said it would be a "disaster" if Covid-19 vaccines are administered, especially to children, without clinical trials

Hetero seeks emergency use authorisation for Merck's antiviral drug

Clinical trial shows molnupiravir helps in early recovery in non-hospitalised Covid-19 patients

Turkey starts phase-2 trials of local Covid-19 vaccine in Istanbul

The phase-2 trials of the locally developed vaccine against Covid-19 started to be administered to volunteers in Istanbul, local media reported