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Results For "antibody"

471 News Found

AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid
Biotech | October 05, 2021

AstraZeneca requests Emergency Use Authorisation for drug to prevent Covid

The filing includes data from PROVENT Phase III trial showing 77% reduction in risk of developing symptomatic Covid-19 with a long-acting antibody combination (non-vaccine)


Takeda to collaborate with JCR Pharma to commercialise next-gen Hunter Syndrome therapy
Biotech | October 01, 2021

Takeda to collaborate with JCR Pharma to commercialise next-gen Hunter Syndrome therapy

Takeda to exclusively commercialize JR-141 outside the U.S. (except Japan and certain other Asia-Pacific countries) upon regulatory approval


Eisai initiates rolling submission for Biological Licence Application of Lecanemab
Biotech | September 28, 2021

Eisai initiates rolling submission for Biological Licence Application of Lecanemab

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology


SAB Biotherapeutics’ SAB-185 moves to Phase 3 trial for Covid-19 treatment
Biotech | September 26, 2021

SAB Biotherapeutics’ SAB-185 moves to Phase 3 trial for Covid-19 treatment

Advancement to Phase 3 is a major milestone for SAB’s unique DiversitAb immunotherapy platform that produces fully human polyclonal antibodies without human donors


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


Aurobindo subsidiary submits MAA for oncology biosimilar
Biotech | September 23, 2021

Aurobindo subsidiary submits MAA for oncology biosimilar

CuraTeQ Biologics is on track for filing a second oncology biosimilar


Pfizer and BioNTech receive U.S. FDA EUA for Covid-19 booster
Drug Approval | September 23, 2021

Pfizer and BioNTech receive U.S. FDA EUA for Covid-19 booster

Emergency Use Authorisation (EUA) is granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups


Boehringer Ingelheim acquires Abexxa Biologics to advance its cancer research
Biotech | September 22, 2021

Boehringer Ingelheim acquires Abexxa Biologics to advance its cancer research

The addition of Abexxa’s expertise complements Boehringer Ingelheim’s current approaches to the treatment of difficult-to-treat solid cancers and especially those resistant to available immunotherapies


Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study
Biotech | September 21, 2021

Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study

In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year


AstraZeneca to set up API facility in Ireland at an investment of US $ 360 million
Supply Chain | September 21, 2021

AstraZeneca to set up API facility in Ireland at an investment of US $ 360 million

The investment programme is expected to significantly reduce commercialisation lead times, costs and introduce more sustainable manufacturing processes