Clinical research
On Tuesday, Novartis announced the first interpretable results from its Phase III KESTREL study of humanized single-chain antibody fragment (scFv) Beovu, demonstrating significant improvement in central subfield thickness in Diabetic Macular Edema.
Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. BioSpace has captured some key efforts.
Regeneron Pharmaceuticals reported that it is pausing enrollment in two of its clinical trials for odronextamab for lymphoma. The U.S. Food and Drug Administration (FDA) placed a partial clinical hold on the trials.
All eyes are turning to Moderna, which has a meeting with the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee on Thursday, December 17. The agency released the data application today.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 15, 2020.
Germany’s CureVac announced it has enrolled the first volunteer in the pivotal Phase IIb/III trial of its own mRNA vaccine candidate, CVnCoV against COVID-19.
Incyte and Novartis announced a Phase III study of Jakafi (ruxolitinib), a first-in-class JAK1/JAK2 inhibitor, failed to hit endpoints as a treatment for patients 12 and up with COVID-19 associated cytokine storm.
The U.S. Food and Drug Administration (FDA) has given the greenlight for V2ACT Therapeutics to proceed with a Phase I/IIa clinical trial of its investigational treatment for newly diagnosed surgically resectable pancreatic cancer.
In a shining moment that signaled hope for hemophilia B patients, uniQure presented data on Tuesday showing that its gene therapy treatment, etranacogene dezaparvovec (AMT-061), substantially increased production of the blood-clotting protein factor IX in nearly all pivotal Phase III HOPE-B trial participants.
The COVID-19 vaccine candidate developed by Sanofi and GlaxoSmithKline hit a snag that will delay the launch of a Phase III study due to an insufficient immune response in older trial patients.
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