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APR003 / Apros TherapApros Therapeutics Announces IND Clearance from U.S. FDA to Initiate the Trial of APR003, an Orally-Administered Gastrointestinal/Liver-Targeted TLR7 Agonist for Treatment of Advanced Colorectal Cancer (CRC) with Malignant Liver Lesions (Businesswire) - Sep 9, 2020 - "Apros Therapeutics, Inc...announced that its Investigational New Drug (IND) application for a Phase 1 dose escalation trial of APR003, the company’s first-in-class orally-administered gastrointestinal- and liver-targeted TLR7 agonist development candidate, was cleared by the FDA. The Phase 1 trial aims to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and initial anti-tumor activity of APR003 in patients with advanced unresectable CRC with malignant liver lesions."Revlimid (lenalidomide) / BMSNICE turns down Celgene's Revlimid as multiple myeloma maintenance treatment (PharmaTimes) - Sep 9, 2020 - "The National Institute for Heath and Care Excellence (NICE) has turned down NHS funding of Celgene's Revlimid (lenalidomide) as maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma in adults. There is currently no maintenance treatment for newly diagnosed multiple myeloma in people who have had an autologous stem cell transplant; the condition is usually monitored until it gets worse...However, NICE has concluded in preliminary guidelines that cost-effectiveness estimates for the drug in this setting 'are uncertain'."Sartate (67Cu MeCOSar octreotate) / Clarity PharmaClarity Pharmaceuticals Announces the US FDA Grants Rare Paediatric Disease Designation to 64Cu-SARTATE, a diagnostic for the clinical management of neuroblastoma (PRNewswire) - Sep 9, 2020 - "Clarity Pharmaceuticals...is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Rare Paediatric Disease Designation (RPDD) to 64Cu-SARTATE™, a diagnostic for the clinical management of neuroblastoma."ADX-629 / AldeyraAldeyra Receives Study May Proceed Letter from FDA to Initiate Clinical Trial of ADX-629 in COVID-19 Patients (Businesswire) - Sep 9, 2020 - "Aldeyra Therapeutics, Inc....today announced that it has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial evaluating ADX-629...for the treatment of adult patients hospitalized for COVID-19. 'The FDA’s clearance of our Investigational New Drug application for Phase 2 testing in patients with COVID-19 is an important milestone for ADX-629'....The planned Phase 2 clinical trial is expected to enroll approximately 30 patients with COVID-19."PBCAR269A / Precision BioSciPrecision BioSciences Receives Fast Track Designation from U.S. Food and Drug Administration for PBCAR269A, an Investigational Allogeneic CAR T Therapy for Relapsed/Refractory Multiple Myeloma (GlobeNewswire) - Sep 9, 2020 - "Precision BioSciences, Inc…announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PBCAR269A for the treatment of relapsed/refractory multiple myeloma. This is the company’s second allogeneic chimeric antigen receptor (CAR T) cell therapy to receive Fast Tack Designation for which the FDA previously granted Orphan Drug Designation."
