Formulation Development
Biomea Fusion Announces First Patient Dosed
Biomea Fusion, Inc. recently announced the first patient has been dosed in its Phase 1 clinical trial evaluating BMF-219, the company’s irreversible covalent menin inhibitor, in patients with….
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….
Checkpoint Therapeutics Announces Positive Topline Results from the Registration-Enabling Trial of Cosibelimab in Metastatic Cutaneous Squamous Cell Carcinoma
Checkpoint Therapeutics, Inc. recently announced positive topline results from its registration-enabling clinical trial evaluating the safety and efficacy of its anti-PD-L1 antibody, cosibelimab, administered as…
Genezen Appoints Senior Director of Business Development to Support Rapid Growth
Genezen, Inc., a cell and gene therapy Contract Development and Manufacturing Organization (CDMO) focused on early phase process development, GMP vector production and analytical testing…
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….
SAB Biotherapeutics Reports Positive Phase 2 Virology Data Demonstrating SAB-185 Met Criteria for Advancement to Phase 3 in NIH ACTIV-2 Trial for Treatment of COVID-19
SAB Biotherapeutics recently reported positive Phase 2 safety and efficacy data demonstrating that SAB-185 met the criteria required for advancement to Phase 3 in the…
Masonic Cancer Center at the University of Minnesota Receives FDA Clearance to Proceed With Phase 1 Clinical Trial in Solid Tumors for HCW9218, HCW Biologics’ Novel Bifunctional Fusion Protein
HCW Biologics Inc. recently announced the Masonic Cancer Center, University of Minnesota was cleared by the US FDA to proceed to evaluate the company’s lead…
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…
ASLAN Pharmaceuticals Initiates Phase 2b Study of ASLAN004 (Eblasakimab) in Moderate-to-Severe Atopic Dermatitis
ASLAN Pharmaceuticals recently announced it has screened the first patient in its Phase 2b dose-ranging clinical study of eblasakimab in adults with moderate-to-severe atopic dermatitis…
eBOOK: Antibody Production
Antibody production is a multi-step complex process and generating reproducible antibodies is highly critical for immunoassays-based research, immunodiagnostics, and immunotherapy. Antibodies’ reproducibility is driven by…
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….
Enteris BioPharma to Participate in Biotech Showcase Virtual & BIO Partnering at JPM During J.P. Morgan Week 2022
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, recently…
Zealand Pharma Completes Enrollment in EASE-SBS 1 Phase 3 Trial Assessing Glepaglutide in Patients With Short Bowel Syndrome
Zealand Pharma A/S recently announced completion of patient enrollment in its pivotal Phase 3 trial (EASE-SBS 1) of glepaglutide, the company’s long-acting GLP-2 analog, for…
First Patient Dosed in IntelGenx’s Resumed BUENA Montelukast VersaFilm Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease
IntelGenx Corp. recently announced patient dosing has resumed in the ongoing Phase 2a (BUENA) clinical trial in patients with mild to moderate Alzheimer’s Disease (AD)…
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…..
BetterLife Receives FDA Response On Its Pre-IND Application For Major Depressive Disorder (MDD) Treatment With BETR-001
BetterLife Pharma Inc. recently announced it has received a written response from the US FDA to its pre-investigational new drug (pre-IND) application for the treatment…
Compass Therapeutics Announces US FDA Clearance of IND Application for Phase 2 Study of CTX-009, a Bispecific Antibody That Simultaneously Targets Delta-like Ligand 4 (DLL4) & Vascular Endothelial Growth Factor A (VEGF-A)
Compass Therapeutics, Inc. recently announced the US FDA has cleared its IND application for CTX-009, enabling the company to initiate a global Phase 2 clinical…
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….
