News about Biotechnology

Lupin: U.S. FDA Grants Mexiletine Orphan Drug Designation

Pharma major Lupin Limited (Lupin) is announced today that the US Food and Drug Administration (U.S. FDA) has granted Orphan Drug Designation (ODD) to mexiletine hydrochloride for the treatment of myotonic disorders

Biotechnology | 08/06/2020 | By Darshana |  728

FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection

Today the U.S. Food and Drug Administration took steps to further support the development of COVID-19 tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website

Biotechnology | 01/06/2020 | By Darshana |  176

FDA Provides New Tool to Aid Development and Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection

Today the U.S. Food and Drug Administration took a new step to support the agency's evaluation of diagnostic tests for COVID-19, by providing a SARS-CoV-2 reference panel. Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance

Biotechnology | 28/05/2020 | By Darshana |  183

ICMR to present fully indigenous diagnostic platform for COVID-19

The Indian Council of Medical Research (ICMR) has validated a fully indigenous diagnostic platform for COVID-19 diagnosis.

Biotechnology | 25/05/2020 | By Darshana |  297

FDA Provides Promised Transparency for Antibody Tests

Today, the U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the notification list of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency

Biotechnology | 22/05/2020 | By Darshana |  193

BELLUS Health Convenes Virtual KOL Meeting to Discuss the State of Chronic Cough Treatment

Bellus a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders, today announced that it will convene a virtual Key Opinion Leader (KOL) meeting to discuss the chronic cough landscape on Wednesday, May 27, 2020 at 9:00 a.m. EDT

Biotechnology | 15/05/2020 | By Darshana |  344

ICMR notifies NIMHANS as mentor institution for RT-PCR test protocol for COVID-19

The National Institute of Mental Health and Neuro Sciences (NIMHANS) has been notified by the Indian Council of Medical Research (ICMR) and the Medical Council of India (MCI) as the mentor institution for RT-PCR (Reverse transcription-polymerase chain reaction) test

Biotechnology | 10/05/2020 | By Darshana |  371

Hydroxychloroquine and Chloroquine Marketto more than Double in 2020 ? TechSci Research

Increase in prevalence of COVID-19 to drive demand for hydroxychloroquine and chloroquine across the globe

Biotechnology | 29/04/2020 | By Darshana |  194

Alembic Pharma gets US FDA approval for Lastacaft ophthalmic solution

Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) alcaftadine ophthalmic solution, 0.25%

Biotechnology | 21/04/2020 | By Darshana |  768

Oncolytics Biotech updates clinical development & operations activities during COVID-19 pandemic

Oncolytics Biotech Inc., currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, provided an update on the potential impact of COVID-19 on the company's clinical and business operations

Biotechnology | 20/04/2020 | By Darshana |  314