Discover
Nuplazid (pimavanserin) / Acadia PharmaACADIA Pharmaceuticals submits supplemental New Drug Application to U.S. FDA for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (Businesswire) - Jun 15, 2020 - "ACADIA Pharmaceuticals Inc....announced today that the company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to support a potential new indication for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP)....The sNDA is supported by results from the pivotal Phase 3 HARMONY study, which met its primary endpoint, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo (hazard ratio = 0.353; one-sided p=0.0023)."Kynmobi (apomorphine sublingual film) / Sumitomo Dainippon, AquestiveSunovion announces Health Canada approval of Kynmobi (apomorphine hydrochloride) soluble film for the treatment of Parkinson’s disease OFF episodes (Businesswire) - Jun 15, 2020 - "Sunovion Pharmaceuticals Inc. (Sunovion) announced today that Health Canada has approved KYNMOBI™ (apomorphine HCI) soluble film for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD)....Sunovion is working to make KYNMOBI available in pharmacies across the Canadian provinces as quickly as possible."vorasidenib (AG-881) / Agios PharmaFDA grants Breakthrough Device Designation to Thermo Fisher Scientific's oncomine precision assay to identify IDH1 and IDH2 mutations in low-grade glioma patients (PRNewswire) - Jun 15, 2020 - "The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Thermo Fisher Scientific's Oncomine Precision Assay to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations who may be eligible for vorasidenib (AG-881)."BPX-603 / BellicumBellicum receives FDA IND clearance to initiate a phase 1/2 clinical trial for BPX-603, a dual-switch GoCAR-T for HER2+ solid tumors (GlobeNewswire) - Jun 15, 2020 - "Bellicum Pharmaceuticals, Inc…announced clearance by the U.S. Food and Drug Administration (FDA) of its investigational new drug application (IND) for BPX-603. BPX-603 is a GoCAR-T® product candidate targeting solid tumors that express human epidermal growth factor receptor 2 (HER2)….'We look forward to initiating our Phase 1/2 trial with BPX-603 targeting solid tumors that express HER2 later this year.'"IND • Trial initiation date
