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PCI Pharma Buys Ajinomoto Althea as Part of $1B Plan to Expand Injectable Drug Manufacturing in the U.S

facility featuring twin lyophilizers and a state-of-the-art large-scale isolator filling line compliant with Annex 1. That facility will be GMP ready this summer; since the plant’s 2022 groundbreaking, PCI has methodically developed...

Stablepharma Launches Phase 1 Trials for First-Ever Fridge-Free Tetanus & Diphtheria Vaccine

Stablepharma Ltd has commenced a Phase 1 clinical trial with its lead candidate, fridge-free tetanus and diphtheria vaccine, SPVX02. The Phase 1, first-in-human clinical trial led by Professor Saul Faust, is being conducted at the National...

Xencor Announces Promising Early Results for XmAb942 in First-in-Human Study Targeting IBD

interim results from its first-in-human study of XmAb942. A high-potency, extended half-life, investigational anti-TL1A antibody in clinical development for patients with inflammatory bowel disease (IBD), such as ulcerative colitis (UC) and Crohn’s...

Bold Therapeutics Presents Late-Breaking Data on BOLD-100’s Ability to Mitigate Oxaliplatin-Induced Peripheral Neuropathy (OIPN)

that its Sr. Director of Preclinical Development, Mark Bazett, PhD, will be presenting a late-breaking poster on BOLD-100's potent neuroprotective properties Mark Bazett will be joined by Jim Pankovich, EVP Clinical Development, and Ashish Kumar,...

At the Longhorn Vaccines and Diagnostics Presents Compelling Data on the LHNVD-303 Vaccine for Sepsis Linked to Bacterial Infections

outcomes with transformative global implications. Broad and Effective Antibody Response: LHNVD-303 generated high-titer IgG1 antibodies in both mice and pigs against LPS, PGN, and LTA, confirming the ability to target conserved epitopes. Antisera...

Innorna Announces FDA Grants Rare Pediatric Disease and Orphan Drug Designations to IN013 for Wilson Disease Treatment

both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) to its investigational mRNA therapy, IN013, for treating Wilson Disease (WD). This dual achievement accelerates the clinical development of IN013, advancing Innorna’s...

Endo's New Spatial Computing Injection Simulator for Peyronie's Disease Creates Immersive Learning Environment for Urology Specialists

the treatment of real patients with XIAFLEX, which represents an important treatment option to help appropriate patients.1 This is the second time Endo has used the power of spatial computing (also called "mixed reality") to create an immersive...

Optune Lua® by Novocure Receives CE Mark Approval for Treating Metastatic Non-Small Cell Lung Cancer

(P=0.035) in median OS. The group treated with Optune Lua concurrently with an immune checkpoint inhibitor or docetaxel (n=137) had a median OS of 13.2 months (95% CI, 10.3 to 15.5 months) compared to a median OS of 9.9 months (95% CI, 8.2 to 11.5...

Molecular Residual Disease and Liquid Biopsy Solutions Launched by Labcorp

to deliver ctDNA detection down to a limit of detection (LOD95) of 0.005%. Results are available approximately 14 days after Labcorp receives the initial sample, and seven days for subsequent monitoring time points for each patient. Labcorp Plasma...

OncoIncytes Launched by 1Cell.Ai (Previously OneCell Diagnostics) to Integrate Multi-Modal Data for Precision Oncology

Tumor DNA (ctDNA), Circulating Tumor Cells (CTCs) at single cell resolution, RNA transcriptomics and Proteomics (150 proteins at the single cell level). Marking its evolution from a genomics-based diagnostic company to an AI-powered leader in...

AI Utilized by TNF Pharmaceuticals and Renova Health to Accelerate Drug Development

to identify high-risk patient groups that may benefit the most from interventions that preserve lean muscle mass during GLP-1 treatment for diabetes, weight loss, and chronic weight management. In keeping with FDA’s recent draft Guidance on using...

BioClear Toenail Fungus Device Under Review: Effective LED Laser for Healthy Nails & Discoloration Treatment

and Ages: Unlike harsh antifungal creams or oral medications, the BioClear device uses UV-free light wavelengths, making it 100% safe for daily use without the risk of burns, irritation, or skin damage. There are no known side effects, and the...

ENHERTU® Plus Pertuzumab Significantly Improves Progression-Free Survival vs. THP in 1st-Line Treatment for HER2+ Metastatic Breast Cancer

meaningful improvement in progression-free survival (PFS) compared to a taxane, trastuzumab and pertuzumab (THP) as a 1st-line treatment for patients with HER2-positive metastatic breast cancer. The PFS improvement was seen across all pre-specified...

Paragonix Celebrates a Major Milestone: 100 Kidney Transplants Powered by the FDA-Cleared KidneyVault™ System

FDA clearance in late 2024 and has been rapidly adopted by likeminded organizations across the nation ever since. Now, over 12 OPOs stock the device, and 100 donor kidneys have been placed in a KidneyVault for transplant. This rapid adoption...

HighField Biopharmaceuticals Files INDs for Two ADCplex™ Immunoliposomes with Distinct Payloads to Address Limitations of Current ADCs

to treat cancer and other diseases, announced today it has filed two investigational new drug (IND) applications (HF158K1 and HFK2) with China’s National Medical Products Administration for immunoliposomes carrying different cancer killing...

VCU Collaboration Launched by Galmed Pharmaceuticals to Address Drug Resistance in GI Cancers

mortality worldwide, and treatment options are often limited by therapy resistance. By targeting Stearoyl-CoA Desaturase 1 (SCD1) – a key enzyme in fatty acid metabolism implicated in cancer progression – Aramchol offers a novel therapeutic...

To Revolutionize Coronary Artery Bypass Surgery, AMT Medical Secures $25 Million in Series B Funding

we’re not just improving outcomes – we’re redefining cardiovascular care.” About AMT Medical: AMT Medical (est. 2017) is an Ede and Utrecht-based innovator spun out of neurovascular ELANA technology which was earlier brought to the market (CE and...

Bruker Introduces nVista 2P Miniature Microscope

“It significantly advances our ability to address compelling scientific questions. Having previously relied on the Inscopix 1P miniscope, we have experienced a seamless transition to the 2P miniscope, further amplifying its value as a powerful tool...

JelloX Biotech Establishes U.S. Research Base

pathology, is announcing it will open a lab in the Discovery Oasis biotechnology space in Phoenix, Arizona. An expansive 120-acre development, Discovery Oasis is envisioned as a biotechnology corridor of collaboration to advance groundbreaking...

CollPlant's Collink.3D® BioInks and Technologies Provide a Timely Alternative to Animal Testing in Line with FDA's New Preclinical Guidelines

These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing. In 2021, CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan,...