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596 News Found

Lancet publishes NanoFlu vaccine Phase 3 trial results
News | September 24, 2021

Lancet publishes NanoFlu vaccine Phase 3 trial results

The pivotal Phase 3 trial achieved all primary endpoints, demonstrating non-inferiority to a leading U.S.-licensed quadrivalent influenza vaccine


U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar
Drug Approval | September 21, 2021

U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar

It becomes the first ophthalmology biosimilar to gain FDA approval in the United States


Excision receives U.S. FDA clearance for first-in-human CRISPR Phase I/II trail for HIV
Biotech | September 18, 2021

Excision receives U.S. FDA clearance for first-in-human CRISPR Phase I/II trail for HIV

Initiation of EBT-101 Phase 1/2 clinical trial expected later this year


Novavax to participate in Oxford university’s study on combining Covid-19 vaccines
Biotech | September 17, 2021

Novavax to participate in Oxford university’s study on combining Covid-19 vaccines

Study to explore heterologous regimen of COVID-19 vaccines from different manufacturers in adolescents 12-16 years of age


U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test
Medical Device | September 16, 2021

U.S. FDA approves Thermo Fisher Scientific’s Oncomine Dx target test

It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations


Boehringer Ingelheim and Twist Bioscience ink antibody discovery collaboration
News | September 13, 2021

Boehringer Ingelheim and Twist Bioscience ink antibody discovery collaboration

Research collaboration covers multiple antibody research programs


Everest Medicines ties up with Providence Therapeutics to supply Covid-19 vaccines in Asia
Biotech | September 13, 2021

Everest Medicines ties up with Providence Therapeutics to supply Covid-19 vaccines in Asia

Everest gains access to a clinically validated mRNA platform and a potentially “best-in-class” mRNA COVID-19 vaccine with full technology transfer


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


Eirion Therapeutics mandates HTL Biotechnology to be its exclusive Botulinum API manufacturer.
Biotech | September 09, 2021

Eirion Therapeutics mandates HTL Biotechnology to be its exclusive Botulinum API manufacturer.

HTL will build, validate and operate a botulinum manufacturing facility in the US


Japan to purchase 150 million doses of Novavax’ Covid-19 vaccine from Takeda
Biotech | September 08, 2021

Japan to purchase 150 million doses of Novavax’ Covid-19 vaccine from Takeda

Takeda is establishing the capability to manufacture TAK-019 (known outside Japan as NVX-CoV2373) at its facilities in Japan and aims to begin distribution in the early calendar year 2022