Formulation Development
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….
Alzheimer’s Disease Preventative Nasal Vaccine to be Tested at Boston's Brigham & Women’s Hospital
Boston's Brigham and Women’s Hospital recently announced it would test a nasal vaccine for Alzheimer’s disease. The move, the hospital said in a press release, represents the culmination of…
SOTIO Expands Its Antibody-Drug Conjugate Pipeline With Exclusive Collaboration & License Agreement With LegoChem Biosciences
SOTIO Biotech recently announced an exclusive, target-specific license and option agreement with LegoChem Biosciences Inc in which SOTIO will obtain rights to deploy LCB’s ADC technology for up to….
Vaxart Announces Publication of Complete Data From Preclinical COVID-19 Oral Vaccine Hamster Challenge Study
Vaxart, Inc. recently announced the Journal of Infectious Diseases has published complete data from Vaxart’s preclinical Hamster Challenge Study. The study shows Vaxart’s COVID-19 oral…
Moderna Announces Positive Data From Phase 2 Study of mRNA VEGF-A Therapeutic in Patients Undergoing Coronary Artery Bypass Grafting Surgery
Moderna, Inc. recently announced positive data from the AstraZeneca-led Phase 2 (EPICCURE) study evaluating the use of an mRNA therapeutic that encodes for vascular endothelial…
Kala Pharmaceuticals Acquires Combangio, Expanding its Pipeline With a Clinical-Stage Novel Biologic for the Treatment of Persistent Corneal Epithelial Defect (PCED) & Other Rare Ocular Surface Diseases
Kala Pharmaceuticals, Inc. recently announced it has acquired Combangio, Inc., a private, clinical-stage company developing regenerative biotherapies for severe ocular surface diseases…..
Inozyme Pharma Announces Dosing of First Patient in First-in-Human Clinical Trial of INZ-701 in Patients With ENPP1 Deficiency
Inozyme Pharma, Inc. recently announced the first patient has been dosed in its first-in-human Phase 1/2 clinical trial of INZ-701 in adult patients with ENPP1…
CymaBay Therapeutics Long-Term Open Label Study Finds Treatment With Seladelpar for 2 Years Improves Key Liver Biomarkers in Patients With PBC
CymaBay Therapeutics, Inc. recently announced that results of analyses from two clinical studies of seladelpar were delivered during The Liver Meeting Digital Experience 2021 (TLMdX)…
Emergex Announces Approval to initiate Phase 1 Clinical Trial of Its Next-Generation COVID-19 Vaccine Candidate
Emergex Vaccines Holding Limited recently announced it has received the necessary regulatory approvals to initiate a Phase 1 clinical trial to evaluate the safety and…
