Daily Top News – September 29, 2020

September 29, 2020

paclitaxel / Generic mfg.; vactosertib (TEW-7197) / National OncoVenture, Medpacto
FDA grants ODD status to Medpacto’s combination therapy (Korea Biomedical Review) – Sep 29, 2020 – “Medpacto said that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) to combination therapy of Vactosertib and paclitaxel for treating metastatic gastric adenocarcinoma….With the ODD designation, the company expects to accelerate the commercialization of Vactosertib and paclitaxel’s combination therapy…’The company expects that the market value of Vactosertib will increase according to the orphan drug designation.'”

 

VERU-111 / Veru Inc
Veru Completes Enrollment of Phase 2 Clinical Trial of VERU-111, Novel Oral Drug for Metastatic Prostate Cancer (GlobeNewswire) – Sep 29, 2020 – “Veru Inc…announced that it has fully enrolled its Phase 2 clinical study of VERU-111, its novel, oral, alpha and beta tubulin targeting drug for metastatic castration and novel androgen receptor targeting agent resistant prostate cancer. The study enrolled a total of 40 men at 13 clinical sites in the United States….’we plan to submit the final Phase 3 pivotal registration study to FDA in Q4 2020 and meet with EMA in Q1 2021.'”

 

difamilast (MM36) / Otsuka, Medimetriks
Medimetriks Announces that Otsuka has Submitted MM36 (difamilast) New Drug Application for Approval in Japan (PRNewswire) – Sep 29, 2020 – “‘Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that a new drug application has been submitted to the Pharmaceuticals and Medical Devices Agency in Japan to seek manufacturing and marketing approval for difamilast (OPA-15406) in patients with atopic dermatitis….’Given the positive outcome of our recent U.S. FDA Type C meeting, Medimetriks is preparing to begin one, final Phase 3 Pivotal Trial in the U.S.'”

 

Abraxane (albumin-bound paclitaxel) / BMS, Otsuka; Tecentriq (atezolizumab) / Roche; eganelisib (IPI-549) / Infinity Pharma
Infinity Receives Fast Track Designation for Eganelisib in Combination with a Checkpoint Inhibitor and Chemotherapy for First-Line Treatment of Advanced TNBC (Businesswire) – Sep 29, 2020 – “Infinity Pharmaceuticals, Inc…announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for eganelisib (IPI-549) in combination with a checkpoint inhibitor and chemotherapy for the treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC), in the first-line setting… Infinity is currently enrolling patients in MARIO-3…to evaluate eganelisib in a novel triple combination front-line regimen with Tecentriq® and Abraxane® in TNBC…We look forward to presenting these important data later this year…The study is designed to enroll approximately 60 patients across two cohorts, approximately 30 patients with programmed death-ligand 1 (PDL1) positive disease based on immunohistochemistry (IHC) and 30 patients with PDL1 negative disease based on IHC.”

 

Reblozyl (luspatercept-aamt) / Acceleron, BMS
Health Canada Approves REBLOZYL (luspatercept), New Class of Treatment for Adult Patients Living with Beta Thalassemia (Businesswire) – Sep 29, 2020 – “Bristol Myers Squibb Canada (BMS) and Acceleron Pharma Inc….announced today that Health Canada has approved REBLOZYL® (luspatercept) for the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta(β)-thalassemia. REBLOZYL® is the first and only erythroid maturation agent in Canada, representing a new class of treatment….Health Canada’s approval of REBLOZYL® is based upon findings from the phase 3, double-blind, randomized, placebo-controlled BELIEVE study…”

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