BioSpace News Archive

Supplemental Biologics License Application (sBLA) Accepted for KEYTRUDA Monotherapy in Patients Whose Tumors Are Tumor Mutational Burden-High (TMB-H) Who Have Progressed Following Prior Treatment

panCELLa is pleased to announce that it will receive advisory services and up to $400,000 from the National Research Council of Canada Industrial Research Assistance Program to help further research and development of its technology platforms for cell therapy.

Magnolia Health, in collaboration with its parent company, Centene Corporation, has recognized Dr. Javel Granados of Desoto Children’s Clinic in Desoto, Mississippi, with a national award for clinical excellence.

Ascentage Pharma announced that it has received approval from the Center for Drug Evaluation of the China National Medical Products Administration for the Phase Ib/II study of APG-2575, the company’s novel Bcl-2‒selective inhibitor, for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

CROMSOURCE, an international contract research organization with its global headquarters in Verona, Italy, has announced that it has initiated its first COVID-19 trial on behalf of a European pharmaceutical company.

Lodo Therapeutics Corp., a biotechnology company applying its proprietary platform to reinvent natural product drug discovery, announced it has achieved a preclinical milestone in its multi-target strategic collaboration with Genentech, a member of the Roche Group.

KalVista Pharmaceuticals, Inc. today announced potential impact of coronavirus disease 2019 (COVID-19) on its ongoing operations

Allurion Technologies Announces Submission of US Premarket Approval (PMA) Application for its Flagship Elipse ® Gastric Balloon Submission paves way for the company’s procedureless™ weight loss device to enter the US Company also names Joyce Johnson as Vice President, Regulatory Affairs and Quality Assurance

Phase I dose escalation completed for BT1718 — RP2D established and preliminary signs of anti-tumor activity observed, including one partial response - Dosing complete in second cohort of Phase I dose escalation for BT5528 — all doses administered in Phase I to date appear tolerable - Significant achievements in multiple partnered programs beyond oncology - Progress across pipeline continues despite uncertainties associated with coronav

Telemedicine collaboration expands comprehensive NURTEC ODT patient affordability and access programs