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Athersys Announces Successful Type B Meeting with the FDA
3/22/2023
Athersys, Inc. announced planned amendments to its MASTERS-2 clinical trial protocol following a Type B meeting with the U.S. Food & Drug Administration (FDA).
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FSD Pharma Announces Its Australian Entity Receives Approval to Proceed With Phase 1 Clinical Trial of Lucid-201, a Candidate for the Potential Treatment of Major Depressive Disorder
3/22/2023
FSD Pharma Inc. today announced that its Australian entity, FSD Pharma Australia Pty Ltd. received the certificate of approval from The Alfred Ethics Committee in Australia to proceed with a Phase 1 study.
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Vistagen Announces Positive Data in Fasedienol (PH94B) Phase 3 Open-Label Study in Adults with Social Anxiety Disorder
3/22/2023
Vistagen today announced positive data from its Phase 3 open-label study designed to evaluate the safety and tolerability of multiple, as-needed intranasal administrations of fasedienol (PH94B) over time in adults with social anxiety disorder (SAD).
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Cognito Therapeutics Raises $73M Series B to Advance Neurotechnology Platform for Alzheimer’s Disease
3/22/2023
Cognito Therapeutics announced today a $73M Series B financing round led by FoundersX Ventures with participation from all existing investors.
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Massive Bio and NeoGenomics Announce Collaboration to Accelerate Oncology Drug Discovery and Improve Patient Care
3/22/2023
Massive Bio, Inc. and NeoGenomics, Inc. today announced a collaboration with the goal of accelerating the development of new cancer therapies and ultimately improving the lives of millions of cancer patients around the world.
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Gilead Sciences Announces $3 Million in Grant Funding to Eight Organizations Addressing HIV Disparities in Rural U.S. Communities
3/22/2023
Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is providing a total of $3 million in grant funding to eight organizations to provide services to communities disproportionately impacted by HIV in rural areas in the United States.
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Truveta and Alpine Immune Sciences Announce Strategic Partnership to Access Truveta’s Community to Accelerate Recruitment to Povetacicept Clinical Trials
3/22/2023
Today, Truveta and Alpine Immune Sciences, Inc. (NASDAQ: ALPN) announced a strategic partnership to help accelerate clinical trial recruitment for povetacicept, Alpine’s dual B cell cytokine antagonist being developed for multiple B cell-mediated autoimmune and inflammatory diseases.
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Visus Therapeutics Completes Enrollment in BRIO-I, a Phase 3 Clinical Trial of BRIMOCHOL™ PF for the Treatment of Presbyopia
3/22/2023
Visus Therapeutics Completes Enrollment in BRIO-I, a Phase 3 Clinical Trial of BRIMOCHOL ™ PF for the Treatment of Presbyopia.
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Ancora Heart’s AccuCinch System Demonstrates Significant Improvement in Quality of Life, Cardiac Structure and Function in Heart Failure Patients
3/22/2023
Ancora Heart, Inc today announced that patients treated with the investigational AccuCinch ® Ventricular Restoration System demonstrated improvement in HF patient outcomes and beneficial changes in the structure of the heart.
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Alzamend Neuro Announces Completion of Clinical Portion of Phase IIA Multiple Ascending Dose Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s
3/22/2023
Alzamend Neuro, Inc. today announced the completion of the clinical portion of its Phase IIA multiple ascending dose (“ MAD ”) study for dementia related to Alzheimer’s.
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EpiBiologics Launches with $50 million Series A Financing to Advance Next-Generation Protein Degradation Platform
3/22/2023
EpiBiologics launched today with $50 million in Series A funding.
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DermBiont Presents Positive Phase 2 Trial Data Treating Seborrheic Keratosis with SM-020 Topical Gel at American Academy of Dermatology Annual Meeting
3/22/2023
DermBiont today announced that its Phase 2 adaptive design trial with of investigational drug SM-020 gel 1.0% met its primary endpoint of a one point improvement in Physician’s lesion assessment (PLA) score at last visit and safety via local tolerability, as well as key multiple secondary endpoints including complete clearance of treated lesions.
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European Commission Grants Orphan Designation for iECURE’s Lead Product Candidate GTP-506 for the Treatment of Ornithine Transcarbamylase (OTC) Deficiency
3/22/2023
iECURE announced today that the European Commission granted orphan designation for the company’s lead product candidate GTP-506 for the treatment of Ornithine Transcarbamylase (OTC) deficiency.
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Josep Bassaganya-Riera Launches NImmune Biopharma with Phase 3-Ready Clinical Candidate Omilancor for the Treatment of Ulcerative Colitis and Crohn’s Disease
3/22/2023
NImmune Biopharma today announced its launch following the acquisition of omilancor, NIM-1324, and the entire LANCL portfolio of immunoregulatory therapeutic assets from Landos Biopharma, Inc.
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Syneos Health and KX Partner to Pioneer Data-Driven Transformation in Biopharmaceutical Asset Development
3/22/2023
Syneos Health today announced a strategic partnership with KX, maker of kdb, the world’s fastest time series database and analytics engine.
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Biohaven Acquires Exclusive License for Oral, Brain-Penetrant, Dual TYK2/JAK1 Inhibitor for Immune-Mediated Brain Disorders
3/22/2023
Biohaven Ltd. (NYSE: BHVN) today announced that it acquired global rights, excluding China regions, for the development of an oral, brain-penetrant, dual inhibitor of Tyrosine Kinase 2 (TYK2) and Janus Kinase 1 (JAK1) for the treatment of brain disorders.
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Invitae and Deerfield Management Partner to Create Novel Therapeutics for Rare Diseases
3/22/2023
Invitae (NYSE: NVTA), a leading medical genetics company, and Deerfield Management Company today announced a partnership to advance genetics-based drug discovery and development in rare disease.
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EvolveImmune Therapeutics Presents New Preclinical Data Demonstrating Improved Anti-Tumor Potential of Novel Costimulatory T Cell Engager Platform at Festival of Biologics Immunotherapy World Congress
3/22/2023
EvolveImmune Therapeutics today announced that new preclinical data on EVOLVE™, the company’s novel costimulatory T cell engager platform, were featured in an oral presentation at the Festival of Biologics Immunotherapy World Congress.
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Plus Therapeutics Initiates Cohort 3 in Phase 1/Part A of the ReSPECT-LM Trial for Leptomeningeal MetastasesFirst data readout of Phase 1/Part A trial expected second half of 2023
3/22/2023
Plus Therapeutics, Inc. today announced treatment of the first patient in Cohort 3 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium ( 186 Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors.
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Medexus Announces New License Deal for Topical Terbinafine
3/22/2023
Medexus Pharmaceuticals (TSX: MDP; OTCQX: MEDXF) is pleased to announce that the company has secured Canadian rights to commercialize terbinafine hydrochloride nail lacquer supplied by Polichem, an Almirall group company focused on medical dermatological treatments for skin health.