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Results For "clinical-data"

185 News Found

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy
Drug Approval | December 07, 2024

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients


Sunbird Bio raises additional US $14 million to advance Alzheimer blood tech test
News | October 21, 2024

Sunbird Bio raises additional US $14 million to advance Alzheimer blood tech test

Financing includes new funding from leading global organizations Eli Lilly and Company and EDBI


AstraZeneca advances science of infectious disease protection at IDWeek 2024
News | October 18, 2024

AstraZeneca advances science of infectious disease protection at IDWeek 2024

Data demonstrate the importance of protecting against serious respiratory infections caused by respiratory syncytial virus, human metapneumovirus and COVID-19


Pfizer withdraws all lots of sickle cell disease treatment voxelotor
News | September 26, 2024

Pfizer withdraws all lots of sickle cell disease treatment voxelotor

Pfizer's decision is based on the totality of clinical data


Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19
News | September 23, 2024

Pfizer and BioNTech receive positive CHMP opinion for Omicron KP.2-adapted COVID-19

Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization


Fasenra recommended for approval in the EU by CHMP for treatment of EGPA
Drug Approval | September 23, 2024

Fasenra recommended for approval in the EU by CHMP for treatment of EGPA

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


Pfizer and BioNTech receive FDA authorization for Omicron KP.2-adapted Covid-19 Vaccine
Drug Approval | August 23, 2024

Pfizer and BioNTech receive FDA authorization for Omicron KP.2-adapted Covid-19 Vaccine

The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older


Merck to acquire investigational B-Cell depletion therapy from Curon Biopharmaceutical
News | August 11, 2024

Merck to acquire investigational B-Cell depletion therapy from Curon Biopharmaceutical

CN201 is a next generation CD3xCD19 bispecific antibody that augments and diversifies Merck’s pipeline, with potential applications in B-cell malignancies and autoimmune diseases


Emmes partners with Miimansa AI to accelerate adoption of Generative AI in clinical research
Digitisation | July 25, 2024

Emmes partners with Miimansa AI to accelerate adoption of Generative AI in clinical research

The partnership will focus on creating capabilities for quickly and accurately processing vast amounts of clinical data


Pfizer and BioNTech receive Positive CHMP opinion for Omicron JN.1-adapted COVID-19 vaccine in EU
News | June 28, 2024

Pfizer and BioNTech receive Positive CHMP opinion for Omicron JN.1-adapted COVID-19 vaccine in EU

Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission