Clinical Trials – media

【EXPERT Q&A】Is it mandatory to conduct clinical trials for drug registration in India?

Drugdu.com expert’s response: Based on the years of experience from Drugdu.com, the number and cases of clinical trials conducted in India are related to the current clinical situation and whether the original research drug is marketed locally. Specific issues require case-by-case analysis. In general, for drug registration in India, if it is a chemical drug or a formulation, and the original research drug is already marketed in India, it can be registered as a generic drug in India, and clinical trials can be waived. Some orphan drugs, especially those that face recruitment challenges in clinical trials and are already marketed in the regulatory markets of Europe and the US, can also apply for exemption from local clinical trials. However, for biologics such as vaccines, monoclonal antibodies, and blood products, conducting phase III (bridging) clinical trials locally is mandatory for registration in India. Taking phase III clinical trials as an example, ...
- Source: drugdu
- 352
- August 9, 2023
Clinical Trials drug registration
Experimental Ebola Vaccines used During Ebola Outbreak in Congo

The health ministry of the DRC announced on 10 August that four new cases of Ebola virus were reported in eastern Democratic Republic of Congo.
- Source: Reuters
- 1,177
- August 14, 2018
Clinical Trials Ebola vaccine
Hemophilia A Gene Therapy by Spark Therapeutics Needs Phase 3 Trial

People with the bleeding disorder hemophilia A require lifelong treatment, which would include regular infusions of a clotting promoter factor VIII. Treatments could be expensive and time-consuming.
- Source: FierceBiotech
- 838
- August 9, 2018
Clinical Trials Gene therapy hemophilia A
GE Healthcare Launches Phase III Trial for Using Flurpiridaz 18F Injection to Detect CAD

GE Healthcare has launched a second phase III (AURORA) clinical trial for using Flurpiridaz 18F Injection in positron-emission tomography (PET) myocardial perfusion imaging (MPI), in order to detect coronary artery disease (CAD).
- Source: The Verdict
- 983
- August 6, 2018
Clinical Trials coronary arteries coronary artery disease
Avatrombopag Reduced Procedure-Related Transfusions in Thrombocytopenia, Chronic Liver Disease Patients

Findings from two international, randomized, double-blind, phase III, placebo-controlled trials published in the September issue of Gastroenterology revealed that the oral second-generation thrombopoietin agonist avatrombopag (Doptelet) when given once a day, notably decreased the requirement for platelet transfusion...
- Source: MDEdge
- 959
- August 3, 2018
chronic liver disease Clinical Trials FDA
Tendyne Mitral Valve Replacement System U.S. Pivotal Trial Started by Abbott

A pivotal clinical study in the U.S. on the Tendyne Transcatheter Mitral Valve Replacement (TMVR) system for treating mitral regurgitation has been commenced by Abbott.
- Source: MPO Mag
- 1,159
- July 31, 2018
Abbott Clinical Trials heart valves medical device
Monoclonal Antibody Delays Cognitive Decline, Erases Alzheimer’s Plaques in Phase 2 Trial

A phase 2 study on BAN2401, a monoclonal antibody that hits soluble amyloid beta oligomers, showed that it limits cognitive decline in patients with slight cognitive injury or premature Alzheimer’s dementia on two scales and removed brain amyloid in 81% of patients in the trial.
- Source: MDEdge
- 978
- July 30, 2018
Alzheimer's disease Clinical Trials FDA
Development of Eye Drop for AMD

Age-related Macular Degeneration (AMD) is the leading cause of blindness among the elderly. The most commonly used drugs to slow the progression of the disease is Roche’s Lucentis and Regeneron’s Eylea. These drugs are injected into the eye which, needless to say, leads to more inconvenience.
- Source: FierceBiotech
- 909
- July 23, 2018
blindness Clinical Trials
Phase 3 Gene Therapy Study on Hemophilia B Launched by Pfizer

Pfizer has initiated its new work on a phase 3 study of an investigational gene therapy designed to treat hemophilia B.
- Source: MedEdge
- 1,243
- July 23, 2018
Clinical Trials hemophilia Pfizer
Assembly Biosciences Initiates Phase 2a Trial for its Lead HBV Core Inhibitor

U.S. based public biotechnology company, Assembly Bioscience revealed the launch of two randomized control phase 2a trials for its leading hepatitis B core inhibitor in a press release.
- Source: Healio
- 1,030
- July 17, 2018
Clinical Trials hepatitis B

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