FDA Accepts Ionis' Donidalorsen NDA for Hereditary Angioedema Prophylaxis
The FDA has accepted Ionis Pharmaceuticals' NDA for donidalorsen, an RNA-targeted medicine, for prophylactic treatment of hereditary angioedema (HAE).
CAR-T Therapy Shows Promise in UK Trial for Lupus Treatment
A new CAR-T therapy is being trialed in the UK as a potential cure for lupus, an autoimmune condition affecting approximately 69,000 people in the UK.
Tenax Therapeutics Appoints Gillian Andor as VP of Clinical Operations to Bolster Phase 3 Program
Tenax Therapeutics has appointed Gillian Andor as Vice President of Clinical Operations to support its Phase 3 program for oral levosimendan (TNX-103).
UK Launches £20 Million Initiative to Boost Dementia Clinical Trial Participation
The UK government has launched the Dementia Trials Accelerator (DTA) with £20 million in funding to increase participation in dementia clinical trials.
MicuRx's MRX-5 Shows Promise in Phase 1 Trial for NTM Infections
MicuRx announced positive results from its Phase 1 clinical trial of MRX-5, an oral antibacterial agent targeting nontuberculous mycobacterial (NTM) infections.
Lyell Immunopharma's IMPT-314 Shows Promise in Phase 1-2 Trial for Large B-Cell Lymphoma
Lyell Immunopharma is presenting initial Phase 1-2 clinical data for IMPT-314, a dual-targeting CAR T-cell therapy, at the ASH Annual Meeting.
Mirikizumab Shows Sustained Remission in Crohn's Disease and Ulcerative Colitis
Eli Lilly's mirikizumab demonstrates long-term efficacy in both ulcerative colitis (UC) and Crohn's disease, marking it as the first IL-23p19 antagonist with multi-year sustained results.
FDA Approves Ziihera (zanidatamab-hrii) for HER2-Positive Biliary Tract Cancer
The FDA granted accelerated approval to Ziihera (zanidatamab-hrii) for previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC).
FDA Approves Ziihera (zanidatamab-hrii) for HER2-Positive Biliary Tract Cancer
The FDA granted accelerated approval to Ziihera (zanidatamab-hrii) for previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC).
Astria Therapeutics Advances Navenibart for HAE with Phase 3 Trial
Astria Therapeutics is initiating the ALPHA-ORBIT Phase 3 trial to evaluate navenibart for hereditary angioedema (HAE) with flexible dosing.
Key Clinical Trial Outcomes of 2024: HIV PrEP, SMA, Obesity, and Alzheimer's Disease
Gilead's lenacapavir demonstrated near-perfect efficacy as a twice-yearly injectable for HIV PrEP in Phase III trials, offering a promising alternative to daily oral treatments.
Clinical Trial Media Achieves High Diversity in Alzheimer's and Other Trials Using AI
Clinical Trial Media (CTM) achieved 62% diverse participant randomization in an Alzheimer's Disease trial, where the condition is most prevalent among Black and Hispanic women.
ProJenX Establishes Clinical Advisory Board to Advance Prosetin in ALS
ProJenX has formed a Clinical Advisory Board (ClAB) comprising experts in ALS clinical trial design to guide the development of prosetin.
Blood Tests Offer Hope for Earlier, Easier Alzheimer's Diagnosis
Blood tests are emerging as a less invasive and more accessible method for diagnosing Alzheimer's disease, potentially leading to earlier treatment and intervention.
Novel mRNA Delivery System Bypasses Liver for Targeted IBD Treatment
Tel Aviv University researchers have developed a groundbreaking method to deliver mRNA-based drugs directly to inflamed intestines while bypassing the liver, potentially revolutionizing IBD treatment.
Novel Liquid Biopsy System Shows Promise in Preventing Cancer Metastasis
University of Basel researchers demonstrate Angle's Parsortix system can capture over 99% of circulating tumor cell clusters from blood samples, enabling breakthrough metastasis prevention research.
Singapore Launches Project Golden Years: Groundbreaking Qualitative Study on Dementia Prevention Attitudes
The National University of Singapore and Cerner Enviza have collaborated on Project Golden Years, investigating evolving attitudes towards dementia prevention in Singapore through real-world qualitative research.
CLEAR OASIS 9 Trial: Colchicine and Spironolactone Show Limited Benefits After Myocardial Infarction
Late-breaking results from the CLEAR OASIS 9 trial reveal that colchicine failed to reduce cardiovascular events after myocardial infarction despite lowering inflammatory markers.
A New Hope for Men with Metastatic Prostate Cancer
The Research Institute of McGill University Health Centre (RI-MUHC) has initiated a global Phase 1 clinical trial for Actinium-225, a novel treatment targeting metastatic prostate cancer. This trial, led by Dr. Ramy Saleh, aims to evaluate the safety and tolerability of Actinium-225, which targets the prostate-specific membrane antigen (PSMA) to kill cancer cells while sparing healthy organs. The study represents a significant advancement in precision medicine for patients who have exhausted other treatment options.
Cordis Launches 10,000-Patient Global Registry for SELUTION SLR Drug-Eluting Balloon
Cordis has initiated the SELUTION Global Coronary Registry, which will track real-world outcomes of their sirolimus-eluting balloon in up to 10,000 patients worldwide for five years.