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Novavax initiates Phase 1/2 trials combining vaccine for Covid-19 and seasonal influenza
Biotech | September 09, 2021

Novavax initiates Phase 1/2 trials combining vaccine for Covid-19 and seasonal influenza

First participants enrolled in Phase 1 clinical trial of combination NanoFlu/NVX-CoV2373 vaccine with Matrix-M adjuvant. The Phase 1/2 study will also evaluate immunogenicity and safety


DCGI grants EUA to Truenat for conducting Nipah virus tests
Digitisation | September 09, 2021

DCGI grants EUA to Truenat for conducting Nipah virus tests

Nipah virus (NiV) is an emerging zoonotic disease that causes severe disease in humans. Signs and symptoms range from asymptomatic to acute respiratory infection and fatal encephalitis


Covid-19 vaccine clinical trial for people with autoimmune disease
Drug Approval | September 03, 2021

Covid-19 vaccine clinical trial for people with autoimmune disease

Researchers at the Feinstein Institutes administer extra vaccine doses as part of the NIH funded study


Novartis signs world’s first agreement with NHS, UK
News | September 03, 2021

Novartis signs world’s first agreement with NHS, UK

The agreement follows positive NICE recommendation and commits to deliver Leqvio (inclisiran) access via a population health management approach identifying eligible patients across England


Janssen announces U.S. FDA approval of Invega Hafyera
Drug Approval | September 02, 2021

Janssen announces U.S. FDA approval of Invega Hafyera

Invega Hafyera offers patients the fewest doses per year. Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months


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


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


Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test
Drug Approval | August 30, 2021

Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test

The Visby Medical sexual health click test is the first instrument-free PCR test for the detection of chlamydia, gonorrhoea and trichomonas, with results available within 30 minutes, during the patient visit


DCGI approves Enzene biosimilar Denosumab for Osteoporosis
Drug Approval | August 28, 2021

DCGI approves Enzene biosimilar Denosumab for Osteoporosis

This is Enzene Biosciences third biosimilar to be approved


Indian National Institute validates Livinguard’s face mask
Drug Approval | August 28, 2021

Indian National Institute validates Livinguard’s face mask

Textiles treated with the technology have also been proven to deactivate viruses, including SARS-CoV-2 (the virus that causes COVID-19).