Recent Headlines
Creative BioMart Enhances Host Cell Protein Mitigation Service to Strengthen Biotherapeutic Quality
Creative BioMart, a leading biotechnology company specializing in protein and biopharmaceutical solutions, has announced an enhancement to its host cell protein service. The upgraded offering introduces a more integrated and data-driven approach to identifying, quantifying, and reducing host cell... - December 11, 2025 - Creative BioMart
DDi Selected by a Large $2 Billion Medical Device Company to Streamline Regulatory Strategy, Intelligence and Assessments
DDi has been selected by a UK-based US $2B medical-device company to streamline its global regulatory strategy, intelligence operations, and regulatory assessments. The partnership strengthens compliance, accelerates market readiness, and leverages DDi’s advanced Visu regulatory-process platform. - November 24, 2025 - DDi LLC
Parvus Therapeutics Reports Positive Phase 1 Results for Lead Autoimmune Treg Therapy, PVT201
PVT201 demonstrated favorable safety, predictable pharmacokinetics, and on-target pharmacodynamic activity in first-in-human study. - November 12, 2025 - Parvus Therapeutics U.S., Inc.
MVT Reports Breakthrough Preclinical Results for MVT‑101 in DVT Model
Microvascular Therapeutics, Inc. (MVT) today announced the publication of compelling preclinical data demonstrating that its proprietary phase‑shift microbubble platform, MVT‑101 (Solv), significantly enhances sonothrombolysis in a clinically relevant porcine model of deep vein thrombosis (DVT). The study appears in the peer‑reviewed journal Nanotheranostics (Vol. 9, Issue 3, 2025). - November 04, 2025 - Microvascular Therapeutics, Inc.
New Report Uncovers What Sponsors Really Think About Preclinical Services and CROs
Life Science Strategy Group’s Preclinical Services Landscape and CRO Benchmarking Assessment Delivers Data-Driven Insights on Budgets, Outsourcing, Vendor Preferences, and Industry Shifts - October 16, 2025 - Life Science Strategy Group, LLC
Cellionyx Exits Stealth Mode with Cytomotion, an FDA-Registered Class I Electroceutical Device Set to Redefine Human Healing and Performance
Cellionyx today emerged from stealth to launch Cytomotion, a first-in-class, FDA-Registered Class I medical device. Shifting the paradigm to true cellular regeneration, Cytomotion utilizes precision-directed electrical fields to activate the body’s innate repair mechanisms. Validated through its licensee Equstech in the elite high performance equestrian sports market, the technology accelerates recovery from injury and proactively optimizes human performance. Commercial launch November 12, 2025. - October 13, 2025 - Cellionyx
Aquaterra Biotech Launches Integrated DNA-to-GMP CDMO Platform in Québec
Aquaterra Biotech Launches Integrated Microbial CDMO Platform from DNA Design to GMP Release Aquaterra Biotech announced an integrated contract development and manufacturing (CDMO) platform that advances microbial and recombinant programs from DNA design to GMP release and logistics. Headquartered... - September 30, 2025 - Aquaterra Biotech
French Biotech 4Dcell Selected to Showcase Next-Gen Cardiac Drug Testing Platform at EIC Corporate Day
French Startup 4Dcell Wins Spot to Show Next-Gen Cardiac Drug Testing Platform at EIC - September 24, 2025 - 4Dcell
YOLO Immune Awarded National Science Foundation SBIR Grant to Advance Novel Immunotherapy for the Treatment of Autoimmune Diseases
YOLO Immune, Inc., a venture-backed biotech company developing precision immunotherapies for the treatment of serious human diseases, today announced it has been awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Science Foundation (NSF). The NSF SBIR program is... - September 19, 2025 - YOLO Immune Inc
National Brain Tumor Society Appoints Renowned Pediatric Oncologist as Chief Scientific Officer
National Brain Tumor Society names leading pediatric cancer expert, Dr. Susan Blaney, as new Chief Scientific Officer. - September 08, 2025 - National Brain Tumor Society
DDi added more AI Agents to enhance Regulatory Strategy, Planning, and Project Actions
DDi introduces AI Agents for Strategy, Planning, and Actions, including Regulatory Insights, Regulatory Impact, and Planning Agents. These tools provide compliance visibility, assess regulatory impacts, and optimize planning, enabling organizations to act with confidence and agility. - August 22, 2025 - DDi LLC
CABRI Fellowship Program Opens for Undergraduate Research Applicants
The Cayman Biomedical Research Institute (CABRI) has announced that applications are now open for their undergraduate research fellowships. Applications may be submitted on the CABRI website from August 11, 2025 through September 29, 2025. - August 15, 2025 - Cayman Chemical Company
YOLO Immune Inc. Emerges from Stealth Mode
YOLO Immune Inc. has emerged from stealth mode to unveil its human-centric drug discovery process and to announce the promotion of its founding research team. YOLO Immune is a venture-backed biotech company developing precision immunotherapies for the treatment of serious human diseases. The... - July 31, 2025 - YOLO Immune Inc
DDi’s Visu Regulatory Platform Now with AI-Powered Project Management & Impact Assessment
DDi enhances its Visu platform with AI-driven project management tools, offering increased efficiency, real-time insights, and risk mitigation for pharma, biotech, and medical device industries. - June 29, 2025 - DDi LLC
Microvascular Therapeutics: Positive Clinical Trial Results with Lead Candidate, CardiSon (MVT-100)
Microvascular Therapeutics, Inc. (MVT), a biotechnology company, announced that it has completed data analysis of its Phase II trial of its new ultrasound contrast agent, MVT-100, CardiSon, in echocardiography. In this study, 16 subjects received either the predicate agent Perflutren, or CardiSon,... - May 15, 2025 - Microvascular Therapeutics, Inc.
Mirror Biologics Announces Publication of Clinical Results Showing Potential for Allo-Priming to Provide Broad Protection to Elderly from Respiratory Viral Infection
A new approach for pandemic preparedness and protection of the elderly from any type of respiratory viral infection. Five injections over two weeks provides possible universal viral protection without need for booster shots. - April 28, 2025 - Mirror Biologics, Inc.
Parvus Announces Achievement of First Milestone from its Collaboration Agreement with AbbVie to Develop IBD Therapies Based on the Parvus Nanomedicine Platform Technology
IND-enabling nonclinical and manufacturing activities executed by Parvus met prospective criteria resulting in the first milestone payment from AbbVie. - April 21, 2025 - Parvus Therapeutics U.S., Inc.
Huntington Study Group Announces Executive Director of Clinical Operations
The Huntington Study Group® and HSG Clinical Research, Inc. (together, “HSG”) are pleased to introduce Carolyn Schultz-Walter as the Executive Director of Clinical Operations. With over 25 years of global clinical operations experience spanning both sponsor and clinical research... - March 31, 2025 - Huntington Study Group
SignaBlok to Present Preclinical Data on TREM-1-Targeting Drug for the Treatment of Cancer at the American Association for Cancer Research (AACR) Annual Meeting 2025
SignaBlok will present positive preclinical data on targeting innate inflammation for the treatment of hard-to-treat cancers. In combination with standard-of-care chemotherapy, SignaBlok's new mechanism-based inhibitor of TREM-1, an inflammation amplifier, prevents cancer recurrence, improves complete response rate and survival in experimental pancreatic cancer. In combination with anti-PD-L1 treatment, it overcomes pancreatic cancer resistance to immunotherapy. - March 21, 2025 - SignaBlok, Inc.
SignaBlok to Present Preclinical Data on TREM-1-Targeting Drug at the Respiratory Innovation Summit and American Thoracic Society International Conference 2025
SignaBlok will present positive preclinical data on targeting innate inflammation for the treatment of sepsis and pulmonary diseases. In experimental sepsis, SignaBlok's new mechanism-based inhibitor of TREM-1, an inflammation amplifier, protects from death with the level of protection not declining at delayed treatment times. In pulmonary inflammation and fibrosis in rats and mice, it reduces neutrophil infiltration in the lungs and reverses fibrosis. - March 21, 2025 - SignaBlok, Inc.
ConductScience Accepted Into NVIDIA Connect Program, Advancing AI-Driven Behavioral Neuroscience Research Solutions
ConductScience joins the NVIDIA Connect program, accelerating AI advancements in behavioral research. This collaboration enhances ConductVision, ConductInsecta, ConductNest, and GaitMaster, optimizing research on locomotion, cognition, and social behavior across species. With NVIDIA’s support, ConductScience gains access to GPU-accelerated computing, engineering resources, and training, driving innovation in neuroscience, genetics, and medicine. - March 16, 2025 - ConductScience
Trump-Era Administration Drug Development & Outsourcing Impact Report
How Tariffs and RFK Jr.’s HHS Appointment May Shift Drug Development & Outsourcing - February 27, 2025 - Life Science Strategy Group, LLC
NuvOx Announces MHRA Approval to Commence Phase IIb Stroke Trial
NuvOx Therapeutics, Inc. (“NuvOx”) announced that The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom in collaboration with the Research Ethics Committee has accepted the amended request for a clinical trial authorisation (CTA). This acceptance will... - February 14, 2025 - NuvOx Therapeutics
DDi Released New ViSU eIFU Version for Medical Device Companies
DDi has launched an updated version of its ViSU eIFU platform, designed for medical device manufacturers to transition from traditional paper instructions to electronic formats. The platform supports regulatory compliance with global standards, including the EU MDR and FDA, while providing multi-language accessibility and an enhanced user experience. - January 17, 2025 - DDi LLC
smartDOC: Automated Content Management Now with GenAI
smartDOC – Intelligent Content Platform for Knowledge Organizations. Easily manage regulatory content with streamlined process, leverage automation and deliver faster with their enterprise document / content system. - November 11, 2024 - DDi LLC
GlycoMira Therapeutics Receives Key Patent for First-in-Class Oncology Therapeutic
Key patent covering GlycoMira's lead compound GM-1111 adds to the Company's already strong IP portfolio. - November 04, 2024 - GlycoMira Therapeutics, Inc.
NuvOx Announces Two New Publications
Co-Founders, Dr. Evan Unger and Dr. Jennifer LH Johnson combine efforts to publish 2 journal articles that help explain how the NuvOx drug candidate - NanO2TM works. Artificial Cells, Nanomedicine, and Biotechnology published Dodecafluoropentane emulsion as an oxygen therapeutic, an article that... - October 31, 2024 - NuvOx Therapeutics
Parvus Announces First Human Subject Dosed in a Clinical Trial with PVT201, a First-in-Class Off-the-Shelf Regulatory T-cell (Treg) Inducing pMHC Nanomedicine Therapy
Parvus Therapeutics, a private clinical-stage biopharmaceutical company developing a pipeline of novel treatments for autoimmune disease announced the successful dosing of the first subject in a Phase 1/2, first-in-human study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PVT201 single ascending doses in healthy subjects and primary biliary cholangitis patients. - October 17, 2024 - Parvus Therapeutics U.S., Inc.
NuvOx Pharma LLC Announces Receipt of Qualified Person’s Declaration Equivalence to UK / EU GMP for Investigational Medical Products
NuvOx Pharma LLC, a wholly owned subsidiary of NuvOx Therapeutics Inc. (together, “NuvOx”) announced that it has received a Qualified Person’s Declaration Equivalence to UK / EU GMP for Investigational Medicinal Products Manufactured outside of EU (in Third Countries) . This... - September 21, 2024 - NuvOx Therapeutics
Sama Therapeutics and Quine Biologics Announce Collaboration to Develop Breakthrough Antibody Therapeutics for Neurological Disorders
Sama Therapeutics and Quine Biologics have partnered to develop an innovative therapy for neurological disorders, combining AI-driven platforms and advanced antibody engineering. The collaboration focuses on biologics that precisely target the central nervous system, minimizing side effects. By integrating Sama's generative AI with Quine's antibody design expertise, the project addresses unmet medical needs and advances treatments for conditions like Alzheimer’s and multiple sclerosis. - September 13, 2024 - Quine Biologics, Inc.
Microvascular Therapeutics Announce Completion of Phase 2 Study Enrollment for MVT-100
Microvascular Therapeutics (MVT), a pioneering healthcare research and development company, is pleased to announce the completion of enrollment in MVT’s Phase 2 program using its microbubble product, MVT-100, for endocardial border delineation. This study, An Ascending Dose Comparison of... - September 13, 2024 - Microvascular Therapeutics, Inc.
Huntington Study Group and HD Genetics Collaborate to Better Serve HD Gene Positive Patients
The Huntington Study Group® and HSG Clinical Research, Inc. (together, “HSG”) are pleased to announce a strategic partnership with HD Genetics to assist patients who have tested positive for Huntington’s disease (HD) learn about and enroll in research studies. There remains a... - September 05, 2024 - Huntington Study Group
Huntington Study Group Announces New CEO
The Huntington Study Group® and HSG Clinical Research, Inc. (together, “HSG”) are pleased to announce that Daniel Claassen, MD, MS, an internationally recognized Huntington’s Disease neurologist and researcher has accepted the role as the organization’s Chief Executive... - August 20, 2024 - Huntington Study Group
Guides Collective Steps in Where Traditional Therapies have Failed with a Concierge Service to Match Seekers with Psychedelic Guides
Guides Collective launches psychedelic concierge service poised to become the "BetterHelp" of the psychedelic space. With over 600+ qualified psychedelic guides in their network, they work with you to find a psychedelic modality catered to a persons specific needs and desired outcome. - August 14, 2024 - Guides Collective
Parvus Therapeutics Announces Leadership Appointments to Support Development from Preclinical Into Clinical
New Positions Enhance Parvus Capability to Execute the Translation of Multiple Drug Candidates into the Clinic. - August 06, 2024 - Parvus Therapeutics U.S., Inc.
Parvus Therapeutics Has Received Orphan Drug Designation for Primary Biliary Cholangitis and Human Research Ethics Committee Approval to Begin Clinical Testing
Parvus Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PVT201 for the treatment of Primary Biliary Cholangitis (PBC) and PVT201 has obtained Australian Human Research Ethics Committee (HREC) approval to initiate a first-in-human... - July 29, 2024 - Parvus Therapeutics U.S., Inc.
Leap Years®: Supports Age-Related Cognitive Decline in Dogs and Quality Time Together with Owners Through NAD+ Enrichment
Animal Biosciences Announces Peer-Reviewed Publication of a Clinical Trial to Evaluate the Slowing of Age-Related Signs in Dogs. After five years of development, clinical results are published regarding senior dog aging in a rigorous, placebo-controlled trial performed at a North Carolina State University College of Veterinary Medicine. - July 23, 2024 - Leap Years
MC4R Agonist Drug Candidates Demonstrate Potential to Transform GLP1 Obesity Therapy
Courage Therapeutics announced new evidence of synergy between MC4R agonists and GLP1RA drugs in a paper published in the Journal of Clinical Investigation led by co-founder Dr. Roger Cone. The company has completed a drug discovery campaign to invent a best in class portfolio of MC4R agonists for obesity in order to leverage the synergy. Potential combinations with drugs such as Ozempic and Mounjaro could improve side effects such as nausea and GI discomfort while driving increased weight loss. - July 16, 2024 - Courage Therapeutics
Huntington Study Group Announces Launch of LEAD-HD Observational Study
The Huntington Study Group® and HSG Clinical Research, Inc. (together, “HSG”) today announce the release of their newest Patient Reported Outcomes (PRO) study, LEAD-HD. This observational study was developed collaboratively with the University of Rochester Center for Health +... - July 15, 2024 - Huntington Study Group
NuvOx Pharma LLC Announces Authorization of ARDS Trial from Health Canada
NuvOx Pharma LLC (“NuvOx”) announced that it has received authorization from Health Canada for its EXTEND: novEl oXygen ThErapeutic NanO2 for mild respiratory distress in Phase Ib and ARDS in Phase II Trials. Evan Unger, MD, CEO of NuvOx, said, “Acute Respiratory Distress... - July 12, 2024 - NuvOx Therapeutics
Cayman Chemical Expands Molecular Diagnostic Research Offerings Through Partnership with PCRassays.com
Cayman Chemical, a leading supplier of research tools for the life science community, has widened their portfolio to include molecular-based detection kits through a strategic partnership with PCRassays.com. PCRassays.com offers more than 200 qPCR-based assays for infectious diseases, over 50 of... - June 07, 2024 - Cayman Chemical Company
Mirror Biologics, Inc. Appoints Elizabeth Czerepak as Chief Financial Officer and VP Corporate Development
Mirror Biologics, Inc., a clinical stage biopharmaceutical company announces the appointment of Elizabeth Adkins Czerepak as Chief Financial Officer (CFO) and Vice President of Corporate Development effective April 15, 2024. Ms. Czerepak has served as CFO of several biotechnology companies over... - April 18, 2024 - Mirror Biologics, Inc.
Huntington Study Group Launches Project AWARE 2.0 Observational Study
The Huntington Study Group® and HSG Clinical Research, Inc. (together, “HSG”) are pleased to announce the launch of Project AWARE 2.0, an observational study developed in collaboration with Roche Products Limited and Genentech to understand and improve Awareness, Willingness, and... - April 10, 2024 - Huntington Study Group
FuseBio Presents New Data at AACR: Targeting a Functionally-Selective IL-18 (F-18) to PD-1: A Next Generation Checkpoint Inhibitor with Enhanced Anti-Tumor Activity
FuseBio's unique attenuation mechanism renders IL-18, a functionally selective IL-18, resistant to IL-18BP and 1 million percent less active in circulation and yet still retain nearly full activity when targeted to PD-1+/IL-18R+ cells, the key functional immune cells in tumors. It is designed to retain full activity of PD-1 checkpoint blockade and simultaneously deliver a functionally selective IL-18 (F-18) to preserve and enhance the anti-tumor activity of immune cells. - April 09, 2024 - Fuse Biotherapeutics
Parvus Announces Collaboration with AbbVie to Develop IBD Therapies Based on the Parvus Navacim Platform Technology
The collaboration will combine AbbVie’s expertise in Immunology with Parvus’ innovative Navacim™ regulatory T cells (Treg) immune tolerization platform technology to develop therapies for Inflammatory Bowel Disease Parvus Therapeutics announced today that it has entered into an... - March 20, 2024 - Parvus Therapeutics U.S., Inc.
iView Therapeutics Inc. Announced FDA’s Clearance of IND Application for IVW-1001 Ophthalmic Eyelid Wipe to Treat Signs and Symptoms of Dry Eye Disease
iView Therapeutics Inc., a clinical stage biotechnology company dedicated to advancing innovative treatments for ocular diseases, announces that the U.S. Food and Drug Administration (FDA) cleared iView’s Investigational New Drug (IND) application to for the initiation of a Phase 1/2 clinical... - March 11, 2024 - iView Therapeutics Inc.
IVIEW Announces Presentation of Positive Topline Results in Phase II Clinical Study of IVIEW-1201 for the Treatment of Bacterial Conjunctivitis at ARVO 2024
IVIEW Therapeutics Inc. announces to present the positive topline result in the Phase II Clinical Study of IVIEW-1201 for the Treatment of Bacterial Conjunctivitis in the upcoming 2024 ARVO (The Association for Research in Vision and Ophthalmology) national meeting in Seattle, WA. The Presentation... - February 28, 2024 - iView Therapeutics Inc.
Cayman Chemical Introduces LipidLaunch™, Expands Portfolio of Lipid Nanoparticle Research Tools to Support Advances in RNA Therapies
Cayman Chemical introduces the latest addition to the company’s portfolio of lipid nanoparticle (LNP) research tools for academic, pharma, and biotech researchers worldwide. The LipidLaunch™ product line helps researchers pursue LNPs for the delivery of nucleic acid therapies in untold health applications, ranging from vaccine development to cancer and cell or gene therapies. - February 22, 2024 - Cayman Chemical Company
Biopharmaceutical Sponsor Interaction with Clinical Site Networks Pulse Report
Sponsor Outsourcing Dollars May Shift to Clinical Site Networks, Transforming the CRO Relationship - February 13, 2024 - Life Science Strategy Group, LLC
Microvascular Therapeutics Welcomes Thom Tulip as Chief Business Officer
Microvascular Therapeutics Inc. (MVT), a clinical-stage biotech company at the forefront of developing the next generation of microbubbles unlocking the therapeutic potential of ultrasound, proudly announces the appointment of Dr Thom Tulip as their new Chief Business Officer. In this pivotal role, Dr Tulip will lead capital raises to propel MVT's cutting-edge technologies into the market. - February 10, 2024 - Microvascular Therapeutics, Inc.