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FDA Clears MindMed IND for MM-120 in Treatment of Generalized Anxiety Disorder
Mind Medicine (MindMed) Inc. recently announced the US FDA has cleared MindMed’s Investigational New Drug application, allowing the company’s Phase 2b dose-optimization trial of….
Lyra Therapeutics Announces Initiation of LYR-210 Pivotal Phase 3 ENLIGHTEN Program in Surgically Naïve Chronic Rhinosinusitis Patients
Lyra Therapeutics, Inc. recently announced the initiation of the Phase 3 ENLIGHTEN I clinical trial of LYR-210 in adult, surgically naïve chronic rhinosinusitis (CRS) patients, with trial sites open for….
Starton Therapeutics Successfully Demonstrates Continuous Drug Delivery of Lenalidomide From a Transdermal Patch in an In Vivo Nonclinical Study With STAR-LLD
Starton Therapeutics Inc. recently announced it successfully obtained promising results in a non-GLP rabbit pharmacokinetic (PK) and skin irritation study of….
Soleno Therapeutics Provides Regulatory Update on DCCR for the Treatment of Prader-Willi Syndrome
Soleno Therapeutics, Inc. recently provided an update following recent interactions with the US FDA regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for….
Kura Oncology Receives FDA Authorization to Proceed With Phase 1b Study of KO-539 in Acute Myeloid Leukemia
Kura Oncology, Inc. recently announced the US FDA has lifted the partial clinical hold on the KOMET-001 Phase 1b study of KO-539 in patients with…
Enteris BioPharma Launches Enhanced Website Showcasing Full Suite of Bench to Market™ Services
Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH), recently announced the launch….
F-star Announces Issuance of US Patent Protecting FS118, a Bispecific Antibody Targeting PD-L1 & LAG-3
F-star Therapeutics, Inc. recently announced the USPTO has granted a patent protecting the composition of matter of FS118, F-star’s tetravalent bispecific antibody which blocks PD-L1 and LAG-3 receptors…..
Spero Therapeutics Awarded up to an Additional $12.9 Million by BARDA to Support the Development of Orally Administered Tebipenem Pivoxil in Pediatric Patients
Spero Therapeutics, Inc. recently announced the company and the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the US….
Kinnate Biopharma Inc. Announces FDA Clearance of Investigational Drug Application for KIN-3248
Kinnate Biopharma Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) application for KIN-3248, a next-generation….
Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19
Revive Therapeutics Ltd. recently provided an update on the company’s US FDA Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine, an oral drug with….
Treadwell Therapeutics Engages Genezen to Advance its T cell Receptor-Based Cell Therapy Pipeline
Treadwell Therapeutics and Genezen have recently confirmed a partnership agreement to accelerate the production of T cell receptor (TCR)-based candidates to address unmet needs in cancer patients…..
Catalent Launches New Xpress PharmaceuticsT Service to Expedite Development of Oral Drugs for Adaptive Phase 1 Clinical Trials
Catalent recently announced the launch of its new Xpress Pharmaceutics service, designed to accelerate the development of oral drugs through Phase 1 clinical studies. By integrating formulation….
CordenPharma Collaborates With PeptiSystems on Continuous Peptide Manufacturing & Green Chemistry
Due to the promising, yet underutilized potential of Green Chemistry and continuous manufacturing synthesis approaches gaining traction in the wider pharmaceutical community, CordenPharma recently announced a collaboration with PeptiSystems, a Swedish-based developer of….
HOOKIPA Announces First Patient Enrolled in Phase 2 Trial Evaluating HB-200 & Pembrolizumab for Treatment of Head & Neck Cancer & Reports FDA’s Fast Track Designation
HOOKIPA Pharma Inc. recently announced the first patient has been dosed with HB-200 in combination with pembrolizumab for the treatment of first-line advanced/metastatic Human Papillomavirus 16….
Resverlogix Announces Commencement of Patient Enrollment & Dosing in a Phase 2b Trial for a Promising Canadian-Developed COVID-19 Treatment
Resverlogix Corp. recently announced enrollment and dosing of patients has commenced in a Phase 2b study at a site at the University of Alberta Hospital in Edmonton. The trial will evaluate the safety and efficacy of apabetalone….
Artizan Biosciences Selects Lead Product Candidate for Inflammatory Bowel Disease Therapeutic Development Program
Artizan Biosciences, Inc. recently announced the selection of its lead product candidate, ARZC-001, for the treatment of inflammatory bowel disease (IBD). Discovered internally and….
Evaxion Biotech Receives Regulatory Clearance to Initiate Phase 2 Trial of EVX-01 in Combination with KEYTRUDA for Treatment of Melanoma
Evaxion Biotech A/S recently announced it has received clearance from the Australia Therapeutic Goods Administration to initiate a Phase 2b trial of its patient specific cancer immunotherapy EVX-01 in combination with….
Evelo Biosciences Presents Data on EDP1815 Mechanism of Action & Supporting Ongoing Clinical Development for Inflammatory Diseases
Evelo Biosciences, Inc. recently announced data for EDP1815, the company’s lead product in inflammation, detailing its mechanism of action and supporting further clinical development in patients with psoriasis and atopic dermatitis…..
Imcyse Reports Positive Immune Response from Interim Analysis of Phase 2 IMPACT Type 1 Diabetes Study
Imcyse recently reported positive biomarker data from a planned interim analysis of its Phase 2 study, IMCY-0098 Proof of ACtion in Type 1 Diabetes (T1D) (IMPACT), evaluating the company’s lead candidate….
Salarius Pharmaceuticals Expands Oncology Pipeline Through Strategic Acquisition of Targeted Protein Degradation Portfolio From DeuteRx, LLC
Salarius Pharmaceuticals, Inc. recently announced a definitive agreement with DeuteRx, LLC to acquire an oral, small molecule targeted protein degradation portfolio. The acquisition includes a lead….
