Clinical Trials & Research

A simple blood draw can provide physicians with valuable information that can determine if peptide receptor radionuclide therapy (PRRT) is likely to be effective in a patient with neuroendocrine cancer. The blood-based biomarker PPQ can predict which patients will respond to PRRT with 96 percent accuracy; changes in another biomarker, NETest, correctly correlate with PRRT

NEWARK, Del. and NANJING, China, April 5, 2023. Biosion USA, Inc. (Biosion), a global clinical-stage R&D biotechnology company, today announced that it has successfully opened an IND following review by the U.S. Food and Drug Administration to initiate a Phase 2 clinical trial of BSI-045B, an anti-TSLP monoclonal antibody (mAb) for the treatment of atopic

A University of California, Riverside, study has identified the biological underpinnings of a reproductive disorder caused by the mutation of a gene. This gene mutation also causes Fragile X Syndrome, a leading genetic cause of intellectual impairment and autism. The researchers found mutations of the Fragile X messenger ribonucleoprotein 1 gene, or FMR1, contribute to

LEIDEN, Netherlands, April 3, 2023. Vico Therapeutics B.V., a clinical-stage genetic medicines company developing therapies for severe neurological diseases, today announced that the first patient has been dosed in a Phase 1/2a clinical study evaluating VO659 for the treatment of Huntington’s disease (HD), spinocerebellar ataxia type 1 (SCA1) and type 3 (SCA3). VO659 is an

Thought LeadersIshani MalhotraCEOCarcinotech In this interview, we speak to Ishani Malhotra, CEO of Carcinotech, about their 3D-printed tumor replicas that are being used to better understand personalized cancer treatments.  Please can you introduce yourself and tell us about your role at Carcinotech? Ishani Malhotra, Chief Executive Officer and founder of Carcinotech, has nine years of

CARLSBAD, Calif., March 29, 2023. Ionis Pharmaceuticals, Inc. today reported that its partner Biogen presented new Phase 1b clinical data showing that IONIS-MAPTRx (BIIB080) reduced soluble tau protein in cerebrospinal fluid (CSF) in a dose-dependent and sustained manner in patients with early-stage Alzheimer’s disease (AD). IONIS-MAPTRx also reduced aggregated tau pathology, as measured by positron

In the wake of a KHN-CBS News investigation, the FDA on Thursday said it is “evaluating safety concerns” over the use of a dental appliance that multiple lawsuits allege caused grievous harm to patients. The federal agency told the public in a “safety communication” posted on its website that it is looking not only at

March 30, 2023 — Results from a multi-site clinical trial supported by the National Institutes of Health showed that less than 1% of people with opioid use disorder whose drug use includes fentanyl experienced withdrawal when starting buprenorphine in the emergency department. The findings, which appeared today in JAMA Network Open, are strong evidence that

Penn Medicine’s hospitals have been honored by the Human Rights Campaign (HRC) Foundation, the educational arm of the nation’s largest lesbian, gay, bisexual, transgender and queer (LGBTQ+) civil rights organization, for its dedication and commitment to LGBTQ+ inclusion. The designations for Penn Medicine’s six acute care hospitals were awarded in the 15th edition of the

TARRYTOWN, N.Y., and SOUTH SAN FRANCISCO, Calif., March 28, 2023 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sonoma Biotherapeutics, Inc. today announced a collaboration to apply their scientific and clinical expertise and respective technology platforms to the discovery, development and commercialization of novel regulatory T cell (Treg) therapies for autoimmune diseases. The collaboration

Some adults who take prescription medication for attention-deficit/hyperactivity disorder are required to have their urine tested for drugs several times a year. Others never are tested. Such screenings are designed to check if ADHD patients are safely taking their pills, such as Adderall, and not selling them, taking too many, or using other drugs. Several

JERSEY CITY, N.J., March 23, 2023- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced it has completed enrollment for the global, multi-center, double-blind, Phase 3b study (MT-1186-A02) evaluating the long-term efficacy and safety of two dosing regimens of RADICAVA ORS (edaravone) in people with amyotrophic lateral sclerosis (ALS) over 48 weeks. This study is the

The National Institute of Allergy and Infectious Diseases awarded an up to $16 million contract to Tulane University to bring to phase one clinical trial a nasal spray vaccine university researchers invented to thwart antibiotic-resistant Klebsiella pneumoniae, a leading cause of pneumonia. Antibiotic-resistant bacteria are on the rise and are a significant cause of infections

SILVER SPRING, Md., March 24, 2023. Today, the U.S. Food and Drug Administration issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support accelerated approval applications. The accelerated approval pathway is commonly used for the approval of oncology drugs in part due to the serious

*Important notice: bioRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information. A team of scientists from Australia and Israel demonstrates that Candida auris, a fungus associated with life-threatening and drug-resistant infections, escapes the host’s innate immune response by

BEIJING, SHANGHAI and BOSTON, March 22, 2023. Jacobio Pharma (1167.HK) announced it has entered into a clinical collaboration with Merck & Co., Inc., Rahway, NJ, USA to evaluate the combination of Jacobio’s CD73 monoclonal antibody JAB-BX102 in combination with Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). The clinical study will evaluate

Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced that its first product based on its novel Illumina Complete Long Read technology is now available to order. The high-performance, long-read, human whole-genome sequencing (WGS) assay – Illumina Complete Long Read Prep, Human – is compatible with Illumina NovaSeq X Plus, NovaSeq

CAPE CANAVERAL, Fla., March 20, 2023. Vaxxinity, Inc., a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today announced that the first subjects have been dosed in a randomized, double-blind, placebo-controlled Phase 1 clinical trial of VXX-401, an investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol, a known factor contributing

On National Close the Gap Day (Thursday 16 March), Diabetes WA is calling for greater recognition of the disproportionate impact of diabetes on Aboriginal Communities in Western Australia. Aboriginal West Australians are at far greater risk of diabetes and diabetes-related complications than any other community in the State.  Image Credit: Diabetes WA Aboriginal West Australians

NEW YORK and TOKYO, March 17, 2023. Pfizer Inc. and Astellas Pharma Inc. (“Astellas”) today announced positive topline results from the Phase 3 EMBARK trial evaluating XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR). Patients enrolled in the trial

New scientific research has found that attending live sporting events improves levels of wellbeing and reduces feelings of loneliness. Published in the journal Frontiers in Public Health, the research is the first large-scale study to examine the benefits of attending any type of live sporting event. The study, carried out by academics from Anglia Ruskin

RAHWAY, N.J.–(BUSINESS WIRE) March 16, 2023 — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided an update on the open-label arm of the non-registrational Phase 2 KeyVibe-002 trial. KeyVibe-002 is evaluating MK-7684A, a coformulation of vibostolimab, an anti-TIGIT therapy, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, with or without

When it comes to cell types, stem cells have unlimited potential – literally. These self-renewing cells, which are capable of giving rise to any cell type in the body, reside in specialized microenvironments known as niches. Now, researchers in Japan have shed new insight into the dynamics of the neural stem cell niche, the home

14 March 2023 — GSK plc (LSE/NYSE: GSK) today announced positive headline results from the phase III trial (NCT04502693) evaluating the safety, tolerability, and immunogenicity of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years. GSK’s MenABCWY vaccine candidate combines the antigenic components of its

*Important notice: medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information. In a recent study posted to the medRxiv* preprint server, researchers at the University of North Carolina and the National Institutes of Health determined the associations between

March 6, 2023 — A clinical trial testing a freeze-dried, temperature-stable experimental tuberculosis (TB) vaccine in healthy adults found that it was safe and stimulated both antibodies and responses from the cellular arm of the immune system. The Phase 1 trial was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of

Pulmonary fibrosis is a devastating disease characterized by progressive scarring in the lungs, killing up to half of patients within five years of a diagnosis. Little is known about whether there are differences in how the condition affects individuals of different ethnicities. New research at the University of Chicago Medicine has found that Black patients

NEWARK, Calif., March 7, 2023. Protagonist Therapeutics, Inc. (“Protagonist” or “the Company”), today announced positive topline results from its collaboration with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), in the FRONTIER 1 Phase 2b clinical trial evaluating the oral Interleukin-23 receptor (IL-23R) antagonist peptide JNJ-2113 in patients with