Formulation Development
Ocuphire Announces Enrollment of First Patients in Second Phase 3 Pivotal Trial (MIRA-3) for Nyxol in Reversal of Mydriasis
Ocuphire Pharma, Inc. recently announced the first subjects have been enrolled in the MIRA-3 Phase 3 pivotal trial evaluating Nyxol Eye Drops in the reversal…
Revive Therapeutics Files for FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation
Revive Therapeutics Ltd. recently announced it has filed an application with the US FDA to receive Orphan Drug Designation (ODD) for Bucillamine for the prevention of ischemia–reperfusion injury (IRI) during liver….
Synlogic Presents Data Demonstrating Reductions in Plasma Phenylalanine Levels in Patients With Phenylketonuria Treated With SYNB1618
Synlogic, Inc. recently announced presentation of interim data from the company's Phase 2 SynPheny-1 clinical trial showing that treatment with the investigational Synthetic Biotic medicine SYNB1618…
Diffusion Pharmaceuticals Doses First Participants in Altitude Trial
Diffusion Pharmaceuticals Inc. recently announced it has dosed the first participants in its Altitude Trial. The trial will evaluate the company’s lead product candidate, trans sodium crocetinate (TSC)….
Zealand Pharma Announces Successful Outcome of Phase 1b Clinical Trial With GLP1-GLP2 Dual Receptor Agonist
Zealand Pharma A/S recently announced topline results from its Phase 1b multiple ascending dose trial with dapiglutide. In this randomized, double-blind, placebo-controlled, multiple ascending dose…
Decibel Therapeutics Announces Extension of Research Term Under Strategic Collaboration With Regeneron to Discover & Develop Gene Therapies for Hearing Loss
Decibel Therapeutics recently announced that Regeneron has extended the research term of its collaboration with the company to discover and develop gene therapies for hearing loss…..
Apollomics Doses First Patient in Phase 3 Clinical Trial With APL-106 (Uproleselan Injection) in Chinese Patients With Relapsed/Refractory Acute Myeloid Leukemia
Apollomics Inc. recently announced the first patient has been successfully dosed in a Phase 3 clinical trial of APL-106 (uproleselan injection) for the treatment of…
Cytovia & Cellectis Expand Their TALEN Gene-Edited iNK Partnership to Enable Broader Collaboration in China
Cytovia Therapeutics, Inc. and Cellectis recently announced they have expanded their collaboration of TALEN gene-edited iPSC-derived NK and CAR-NK cells to include new CAR target and….
Stanford Scientists First to Identify New Cellular Correlates of Protection Against Influenza for an Oral Flu Vaccine Developed by Vaxart
A new Stanford study published in Cell Host and Microbe has demonstrated that VXA-A1.1, an investigational oral tablet flu vaccine under development by Vaxart, Inc.,…
Metrics Contract Services Completes ANVISA Regulatory Inspection
Metrics Contract Services, a division of Mayne Pharma, recently announced its Greenville, NC, facility has successfully completed an inspection by the Agência Nacional de Vigilância…
BioNTech Receives FDA Fast Track Designation for its FixVac Candidate BNT111 in Advanced Melanoma
BioNTech SE recently announced the US FDA granted Fast Track Designation for BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma. BNT111…
ImmunityBio Expands Vaccine Program to Accelerate Use of “Mix-and-Match” Technologies in Developing & Manufacturing Next-Generation COVID-19 Vaccines
ImmunityBio, Inc. recently announced the expansion of the company’s cancer and infectious disease vaccine programs to include self-amplifying self-adjuvating RNA (SASA-RNA), recombinant protein vaccine candidates, and potent adjuvant formulations that….
Sterling Pharma Solutions Announces $13.5-Million Investment at Dudley, UK, to Increase Process Development & Manufacturing Capacity
Sterling Pharma Solutions recently announced the next phase of a multi-year investment strategy at its site in Dudley, UK. The $13.5-million plan will see the…
Artizan Biosciences & Biohaven Therapeutics Announce Therapeutic Development Program in Parkinson’s Disease
Artizan Biosciences, Inc. and Biohaven Therapeutics Ltd. recently announced the companies are initiating a therapeutic discovery and development program in Parkinson’s disease (PD), to exploit recent….
Verrica Pharmaceuticals Announces FDA Acceptance of its IND Application for Potential First-in-Class Oncolytic Peptide-Based Immunotherapy for the Treatment of Basal Cell Carcinoma
Verrica Pharmaceuticals Inc. recently announced the US FDA has accepted its Investigational New Drug Application (IND) for LTX-315, a potential first-in-class oncolytic peptide, for the…
Molecular Templates Announces Fast Track Designation Granted by FDA for MT-6402
Molecular Templates, Inc. recently announced the US FSA has granted Fast Track Designation for MT-6402 for the treatment of patients with advanced non-small cell lung…
First Subject Dosed in Biosplice Therapeutics Phase 1b Clinical Trial in Oncology
Biosplice Therapeutics, Inc. recently announced the dosing of the first subject in a Phase 1b, open-label, multi-center, dose-escalation, dose expansion clinical trial of cirtuvivint in…
OWP Pharmaceuticals Announces IND Authorization for the First-Ever Oral Liquid Formulation of Atomoxetine Hydrochloride for the Treatment of ADHD
OWP Pharmaceuticals, Inc. recently announced it has received IND authorization from the FDA for the first-ever oral suspension of atomoxetine hydrochloride. Offering an important delivery…
Denali Therapeutics Announces Strategic Partner Takeda Exercises Option to Co-Develop & Co-Commercialize Brain-Penetrant Progranulin Replacement Therapy
Denali Therapeutics Inc. recently announced its strategic partner Takeda Pharmaceutical Company Limited has exercised an option, pursuant to an existing collaboration agreement between the two…
Arranta Bio Announces Completion of Sale of Florida Site & Progress on $150-Million Investment Plan to Expand Development & Commercial Manufacturing Services
Arranta Bio recently announced the completion of the sale of its process development and GMP clinical manufacturing site in Gainesville, FL, to Inceptor Bio and the transfer of client programs and key….
