News about Clinical Trials

China to run human coronavirus vaccine trial in UAE

China to run human coronavirus vaccine trial in UAE

China National Biotec Group (CNBG) has won approval to run a large-scale Phase 3 clinical trial of its novel coronavirus vaccine candidate in the United Arab Emirates (UAE), the company said. China is seeking to trial potential vaccines overseas because of a lack of new patients at home

Clinical Trials | 25/06/2020 | By Darshana

Roche's IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone met one of its co-primary endpoints

Roche's IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone met one of its co-primary endpoints

Roche today announced that the phase III IPATential150 study met its co-primary endpoint of radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC) and whose tumours had PTEN loss

Clinical Trials | 19/06/2020 | By Darshana

FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk

FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk

The U.S. Food and Drug Administration has issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody test

Clinical Trials | 18/06/2020 | By Darshana

Roche initiates phase III clinical trial of Actemra/RoActemra plus remdesivir in hospitalised patients with severe COVID-19 pneumonia

Roche initiates phase III clinical trial of Actemra/RoActemra plus remdesivir in hospitalised patients with severe COVID-19 pneumonia

Roche announced the initiation of a global phase III, randomised, double-blind, multicentre study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc

Clinical Trials | 28/05/2020 | By Darshana

FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion

FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion

Today, the U.S. Food and Drug Administration approved Retevmo (selpercatinib) capsules to treat three types of tumors ? non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers ? in patients whose tumors have an alteration (mutation or fusion) in a specific gene

Clinical Trials | 10/05/2020 | By Darshana

ICMR announces protocol for Therapeutic Plasma Exchange therapy in COVID-19 patients

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

Roche provides regulatory update on risdiplam for the treatment of spinal muscular atrophy (SMA)

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

First patient outside U.S. treated in global Kevzara clinical trial program for patients with severe COVID-19

First patient outside U.S. treated in global Kevzara clinical trial program for patients with severe COVID-19

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

Pfizer’s sNDA for Eucrisa to treat children as young as 3 months of age with mild-to-moderate AD receives US FDA approval

Pfizer’s sNDA for Eucrisa to treat children as young as 3 months of age with mild-to-moderate AD receives US FDA approval

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

Luminex Provides Update on SARS-CoV-2 Validation Testing Efforts

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

 
 

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