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ICMR announces protocol for Therapeutic Plasma Exchange therapy in COVID-19 patients
The Indian Council of Medical Research (ICMR) has announced protocol for a multi-center, phase II, open label, randomized controlled study named Therapeutic Plasma Exchange (TPE) in COVID-19 for its therapy. The therapy is also called convalescent plasma therapy which according to health experts has the potential to treat critically ill COVID-19 patient
Clinical Trials | 15/04/2020 | By Darshana | 295
Roche provides regulatory update on risdiplam for the treatment of spinal muscular atrophy (SMA)
Roche, announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of risdiplam with a decision expected by August 24, 2020
Clinical Trials | 13/04/2020 | By Darshana | 346
The first patient outside of the U.S. has been treated as part of a global clinical program evaluating Kevzara in patients hospitalized with severe COVID-19. The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the United States, all countries that have been impacted by COVID-19
Clinical Trials | 30/03/2020 | By Darshana | 286
Pfizer announced that the US Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Eucrisa (crisaborole) ointment, 2%, extending the lower age limit from 24 months down to 3 months in children with mild-to-moderate atopic dermatitis (AD), also known as eczema
Clinical Trials | 26/03/2020 | By Darshana | 593
Luminex Provides Update on SARS-CoV-2 Validation Testing Efforts
Luminex Corporation announced today that four independent clinical laboratories have validated laboratory developed tests (LDTs) for automated, rapid detection of the SARS-CoV-2 virus using the sample-to-answer ARIES® System
Clinical Trials | 18/03/2020 | By Darshana | 293
Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, today announced it has successfully discovered a novel genetic biomarker associated with DB104 response to treat depression using its proprietary biomarker discovery platform
Clinical Trials | 15/03/2020 | By Darshana | 412
Biocon & Mylan Win Patent Litigation Asserted by Sanofi for Insulin Glargine Device
Biocon Ltd.announced today that it has won a U.S. court ruling that invalidated a Sanofi patent on the Insulin Glargine device , removing a key legal hurdle to commercializing Semglee® (Insulin Glargine) co-developed with Mylan, in the U.S.
Clinical Trials | 15/03/2020 | By Darshana | 242
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