Wednesday, April 23, 2025

Yearly Archives: 2020

Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19

May 11, 2020: "The U.S. Food and Drug Administration took important actions to help accelerate the development of prevention and treatment options for COVID-19...

Sarclisa® (isatuximab) Phase 3 IKEMA trial meets primary endpoint early in patients with relapsed multiple myeloma

May 12, 2020: "The Phase 3 IKEMA clinical trial evaluating Sarclisa® (isatuximab) added to carfilzomib and dexamethasone met the primary endpoint at its first planned...

ABBOTT RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR COVID-19 ANTIBODY BLOOD TEST ON ALINITY™ I SYSTEM

May 11, 2020: "Abbott announced that the U.S. FDA issued Emergency Use Authorization (EUA) for the company's SARS-CoV-2 IgG lab-based serology blood test on...

NICE draft guidance recommends new treatment option for people with early breast cancer

May 07, 2020: "Roche's Kadcyla (trastuzumab emtansine)should soon be available on the NHS as a treatment option for patients with HER2-positive early breast...

Lynparza approved in the US as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer

May 11,2020: AstraZeneca and MSD announced that Lynparza (olaparib) in combination with bevacizumab has been approved in the US for the maintenance treatment of adult patients...

AstraZeneca recovery of global rights to brazikumab from Allergan completed

May 11, 2020: "AstraZeneca has completed a previously communicated agreement to recover the global rights to brazikumab (formerly MEDI2070), a monoclonal antibody targeting IL23, from Allergan. AstraZeneca and Allergan have terminated their previous license...

AstraZeneca’s US Breakthrough Therapy Designation for Enhertu

May 11, 2020: "AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the...

Clinical Trial: Introduction & Types

"According to the FDA, Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human...

Phases of Clinical Trials

Phases of Clinical Trials are the steps which are followed to test the drug in the different number of healthy volunteers/patients. Clinical trials are experiments or observations done in clinical research....

Coronavirus (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients

May 09, 2020: "The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new...

Clinical Research Associate: Role, Responsibilities, Skills, and Salary

Introduction: Clinical Research Associate may be employed directly by the sponsor companies of clinical trials or by Clinical Research Organizations (CROs) CROs conduct clinical trials...

Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens

May 08, 2020: "The U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for...
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