Formulation Development
Hepion Pharmaceuticals Receives FDA Fast Track Designation for CRV431 for the Treatment of NASH
Hepion Pharmaceuticals, Inc. recently announced the US FDA has granted Fast Track designation for the company’s lead drug candidate, CRV431, for the treatment of NASH.…
Akoya Biosciences Secures CLIA Lab Certification, a Milestone for Applying its Spatial Biology Technologies to Accelerating Precision Cancer Therapies
Akoya Biosciences, Inc., The Spatial Biology Company, recently announced its Advanced Biopharma Solutions (ABS) laboratory, located in Marlborough, MA, has received its Certificate of Registration from the….
TARGETED ONCOLOGY THERAPIES - Harnessing Nature’s “Cues” to Selectively Activate the Immune System to Attack Cancer
Dan Passeri, MSc, JD, reviews a new class of synthetic biologic drugs engineered and designed to leverage the beneficial effect of IL-2 to selectively stimulate the proliferation and cytotoxic activity of disease-relevant T cells against cancer.
Gb Sciences Accelerates Drug Development Via Innovative Biopharma Technology & Strategic Partnerships
Recognizing the glacial pace of traditional drug research and development processes and the adverse effect of this on patients, biopharmaceutical company Gb Sciences has taken innovative steps to speed up….
RespireRx Pharmaceuticals Announces Publication of Preclinical Results Supporting the Use of AMPAkines in the Treatment of Human Spinal Cord Injury
RespireRx Pharmaceuticals Inc. recently announced the publication by Dr. David Fuller (University of Florida) and his colleagues of two new, scientific articles in major, peer-reviewed…
Adial Pharmaceuticals Announces Positive Preclinical Data for PNV2 as a Drug Candidate for Triple Negative Breast Cancer
Adial Pharmaceuticals, Inc. recently announced positive preclinical data for PNV2 in an animal model of triple negative breast cancer (TNBC). Based on the strength of…
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….
