Monday, January 25, 2021

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Scientists tackle vaccine safety, efficacy and access at global R&D forum

January 16, 2021: "More than 2,800 scientists from 130 countries gathered on Friday (January 15) in a virtual forum hosted by the...

Pfizer’s Xalkori® approved by FDA for alk-positive anaplastic lymphoma

January 14, 2021: "Pfizer Inc. announced that the U.S.FDA approved the supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) for the treatment of pediatric...

GSK presents positive efficacy data of dostarlimab at ASCO Gastrointestinal Cancers Symposium

January 16, 2021: "GlaxoSmithKline (GSK) plc announced updated data from GARNET cohort F evaluating dostarlimab in mismatch repair-deficient (dMMR) non-endometrial advanced solid...

Bharat Biotech signs agreement with Precisa Medicamentos for supply of ‘COVAXIN™’ to Brazil

January 12, 2020: "Bharat Biotech announced that it has signed an agreement with Precisa Medicamentos for the supplies of COVAXIN™ to Brazil.

What Is a Blockbuster Drug?

What Is a Blockbuster Drug? "Blockbuster drugs are those that generate at least $1 billion of revenue per...

Boehringer Ingelheim and Enara Bio join forces to discover Cancer Immunotherapies

January 12th, 2021: Boehringer Ingelheim and Enara Bio announced that they have entered into a strategic collaboration and licensing agreement to research...

Novartis ligelizumab receives FDA Breakthrough Therapy designation for CSU

Jan 14, 2021: "Novartis announced that the U.S. Food and Drug Administration (FDA) has granted ligelizumab (QGE031) Breakthrough Therapy designation for the...

ViiV Healthcare receives EU Marketing Authorisation for the dolutegravir for HIV

ViiV Healthcare receives EU Marketing Authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in...

Roche’s Tecentriq/Avastin combination improves survival in liver cancer

January 12, 2021: Roche will present updated overall survival (OS) data from the Phase III IMbrave150 study evaluating Tecentriq® (atezolizumab) in combination...

Vir Biotechnology and GSK announce NHS-supported AGILE study for COVID-19

January 12, 2021: Vir Biotechnology and GlaxoSmithKline announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild...

Novartis expands Oncology pipeline with in-licensing of tislelizumab from BeiGene

January 11, 2021: "Novartis has signed a strategic collaboration agreement to in-license tislelizumab from BeiGene, Ltd. in major markets outside of China,...

FDA Releases Artificial Intelligence/Machine Learning Action Plan

January 12, 2021: "The U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)...

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What is the process for Submission of Synopsis?

1.1 a. "Prior to submission of a thesis synopsis, a comprehensive assessment of the research work should be carried out by a...

COVAX Announces new agreement, plans for first deliveries

January 22, 2021: COVAX, the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income...

FDA Approves OPDIVO® with CABOMETYX® as First-line Treatment for advanced Renal Cell Carcinoma

22 Jan 2021:  Bristol Myers Squibb announced that OPDIVO®(nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks...

FDA granted approval of Cabenuva and Vocabria to ViiV Healthcare for HIV

January 21, 2021: "The U.S. FDA approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human...