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Results For "filing"

512 News Found

Novavax submits variations to expand approval in Australia and New Zealand for adolescents
Biotech | May 08, 2022

Novavax submits variations to expand approval in Australia and New Zealand for adolescents

If granted, Nuvaxovid would be the first protein-based Covid-19 vaccine option for adolescents in Australia and New Zealand


Scipio bioscience announces its revolutionary Asteria single-cell RNA-seq kit
Biotech | May 04, 2022

Scipio bioscience announces its revolutionary Asteria single-cell RNA-seq kit

At an affordable price, a researcher can process fresh samples of 10,000 cells immediately with a stable stopping point within two hours, simplifying sample management at the laboratory and limiting transcriptional changes


Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone
Biotech | May 02, 2022

Sage Therapeutics and Biogen initiate rolling submission of New Drug Application for Zuranolone

The companies expect to complete the submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression is anticipated in the first half of 2023


Sanofi continues to deliver strong business
News | April 28, 2022

Sanofi continues to deliver strong business

Business EPS of €1.94, up 20.5% on a reported basis and 16.1% at CER, also benefitting from an improved effective tax rate


Lonza and Integral Molecular partner on biotherapeutics
News | April 26, 2022

Lonza and Integral Molecular partner on biotherapeutics

The respective expertise of Lonza and Integral Molecular will benefit drug developers in the assessment of the risk for off-target binding and activation


Shionogi’s once-a-day Covid-19 anti-viral shows rapid virus clearance
Biotech | April 25, 2022

Shionogi’s once-a-day Covid-19 anti-viral shows rapid virus clearance

A separate global Phase 3 study of S-217622 is underway aiming to recruit participants globally to support regulatory filings this year


Porton Advanced and Sinorda Biomedicine collaborate for cell therapy development for solid tumours
Biotech | April 25, 2022

Porton Advanced and Sinorda Biomedicine collaborate for cell therapy development for solid tumours

Under the agreement, Porton Advanced will provide services to accelerate the development, production and registration of breakthrough cell therapies currently being developed by Sinorda Biomedicine


Evusheld significantly protected against symptomatic Covid-19 for at least six months
Biotech | April 21, 2022

Evusheld significantly protected against symptomatic Covid-19 for at least six months

Pre-exposure prevention trial reduced risk of symptomatic Covid-19, with no severe disease or Covid-19-related deaths in the Evusheld group


Purigen launches ionic cells to pure DNA kit
Biotech | April 21, 2022

Purigen launches ionic cells to pure DNA kit

New kit enhances menu of FFPE solutions and allows oncology researchers to extract higher yields of concentrated DNA compared to traditional techniques


Zydus Lifesciences receives final approval from USFDA for Cyanocobalamin Injection
Drug Approval | April 18, 2022

Zydus Lifesciences receives final approval from USFDA for Cyanocobalamin Injection

The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat