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Modified COVID-19 vaccines can avoid ‘lengthy’ clinical studies, says MHRA
pharmatimes
March 05, 2021
Updated COVID-19 vaccines that are modified in response to new variants will not require a brand new approval or ‘lengthy’ clinical studies to receive authorisation, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced.
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Parexel and NeoGenomics announce partnership to improve clinical trials
expresspharma
February 25, 2021
The companies will collaborate to optimise study designs and speed up patient matching in oncology clinical trials.
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China approves clinical trials for 16 indigenous COVID-19 vaccines
expresspharma
February 22, 2021
China has already given conditional approval to two inactivated COVID-19 vaccines made by state-owned developers -- Sinopharm and Sinovac Biotech.
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AstraZeneca COVID-19 Vaccine Confirms 100% Protection Against Severe Disease in Phase III Trials
americanpharmaceuticalreview
February 08, 2021
The primary analysis of the Phase III clinical trials from the UK, Brazil and South Africa, published as a preprint in The Lancet confirmed COVID-19 Vaccine AstraZeneca is safe and effective at preventing COVID-19, with no severe cases and no ...
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AstraZeneca expects US trial results in next 4-6 weeks, research chief says
expresspharma
February 08, 2021
Some experts had expected the data sooner than that, given the high infection rates in the United States during the period of testing.
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TCAI physicians participate in clinical trial for potential life-saving device for patients with heart rhythm disorders
prnasia
February 05, 2021
Physicians with the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center are among the first in the world to participate in a clinical trial to evaluate a new esophageal protection device designed to make ablation procedures safer ...
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Oxford Kept COVID-19 Vaccine Trial Volunteers in Dark About Dosing Error, Letter Shows
expresspharma
February 04, 2021
The letter was signed by the trial’s chief investigator, Oxford professor Andrew J. Pollard, and sent to the trial subjects.
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Jemincare initiates phase I clinical trial of anti-SARS-CoV-2 neutralizing antibody JMB2002
prnasia
January 20, 2021
On January 15, Jemincare Group, a Chinese pharmaceutical company, announced that it has initiated the phase I clinical trial of anti-SARS-CoV-2 neutralizing antibody (JMB2002).
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Dr Reddy’s gets DCGI nod for Phase 3 clinical trial for Sputnik V vaccine
expresspharma
January 18, 2021
The phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India.
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Halt Bharat Biotech’s COVAXIN trial in Bhopal: Civil society organisations
expresspharma
January 15, 2021
These organisations state that unethical conduct, protocol violations in a clinical trial where an apex government body is a co-sponsor is particularly alarming.