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, ...
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).
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...
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.
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.
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