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SK Bioscience and GSK start Phase 3 trial of an adjuvanted COVID-19 vaccine candidate
Drug Approval | September 01, 2021

SK Bioscience and GSK start Phase 3 trial of an adjuvanted COVID-19 vaccine candidate

Advance to Phase 3 follows positive interim Phase 1/2 immunogenicity and safety data. The global clinical trial will evaluate vaccine candidate GBP510 against the AZ/Oxford COVID-19 vaccine


WHO releases compendium of innovative health technologies
Policy | September 01, 2021

WHO releases compendium of innovative health technologies

The Covid-19 pandemic has exposed the divide that exists between rich and developing nations and to address these challenges the World Health Organisation (WHO), has compiled a list of innovative health technologies that aim to bridge the gap


US FDA clears InnoCare’s clinical trial of pan-TRK Inhibitor ICP-723
Drug Approval | August 31, 2021

US FDA clears InnoCare’s clinical trial of pan-TRK Inhibitor ICP-723

The clinical trial will evaluate the safety, tolerability and pharmacokinetic properties of ICP-723 in patients with solid tumours, and evaluate the anti-tumour efficacy of ICP-723 on NTRK fusion-positive cancers


Sanofi’s Dupixent pivotal trial meets all primary and secondary endpoints for treatment of atopic dermatitis
Biotech | August 31, 2021

Sanofi’s Dupixent pivotal trial meets all primary and secondary endpoints for treatment of atopic dermatitis

Results reinforce the well-established safety profile of Dupixent - the first-ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old


Union Minister Mansukh Mandaviya inaugurates Bharat Biotech’s Ankleshwar facility
News | August 29, 2021

Union Minister Mansukh Mandaviya inaugurates Bharat Biotech’s Ankleshwar facility

The facility has the capacity to produce one crore doses per day


European Commission grants market authorisation for BioMarin’s Voxzogo
Biotech | August 28, 2021

European Commission grants market authorisation for BioMarin’s Voxzogo

It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo


U.S. FDA approves drug-free VNS system for stroke
Drug Approval | August 28, 2021

U.S. FDA approves drug-free VNS system for stroke

When used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke


Japan approves AstraZeneca’s Forxiga for chronic kidney disease
Drug Approval | August 28, 2021

Japan approves AstraZeneca’s Forxiga for chronic kidney disease

Over 13 million people in Japan suffer from chronic kidney disease and this will transform treatment options


Roche withdraws the US accelerated approval for Tecentriq
Drug Approval | August 28, 2021

Roche withdraws the US accelerated approval for Tecentriq

Roche is notifying healthcare professionals and patients in the US about this withdrawal. Patients being treated with Tecentriq for PD-L1-positive mTNBC should discuss their care with their healthcare provider


Brazil’s Eurofarma to manufacture Comirnaty for Latin America
Biotech | August 27, 2021

Brazil’s Eurofarma to manufacture Comirnaty for Latin America

The manufacture of finished doses will commence in 2022 and at full operational capacity, the annual production is expected to exceed 100 million doses annually