Clinical Trials

Nutrient Intake Is Inversely Related to Metabolic Syndrome Incidence

by Veronica Salib

A publication in JAMA Network Open found that folate, vitamin B6, and vitamin B12 intake and serum levels are inversely related to metabolic syndrome (MetS) incidence, with higher intake levels...

Scientists at the University of Washington Study Breast Cancer Vaccine

by Veronica Salib

Early phase studies by scientists at the University of Washington found that a plasmid DNA breast cancer vaccine may produce favorable outcomes, generating anti-tumor immunity. The study, published in...

Considerations in Pediatric Clinical Trials, Ensuring Patient Safety

by Veronica Salib

The clinical trial landscape — globally and in the United States — is one of many complexities, difficulties, implications, and guidelines. Clinical trials can provide critical information on treating chronic and acute...

FDA Grants Approval for HIV Treatment to Fight Drug Resistance

by Hayden Schmidt

Last week, the FDA approved Gilead Science’s Sunlenca (lenacapavir), the first and only capsid inhibitor-based HIV treatment. The treatment is intended for adult patients whose HIV cannot be...

Merck and Moderna Find Success with Cancer Vaccine Clinical Trial

by Hayden Schmidt

Pharmaceutical companies Merck & Co and Moderna Inc announced positive clinical trial results for their investigational melanoma vaccine candidate last week. The personalized cancer treatment that...

Janssen Submits Biologics License Application for Talquetamab

by Veronica Salib

According to a recent press release, Janssen recently submitted a Biologics License Application (BLA) to the FDA for talquetamab to treat relapsed or refractory multiple myeloma. The CDC states that...

AHA Funds Research Network to Advance Clinical Trial Diversity

by Veronica Salib

Clinical trial diversity is a necessity for ensuring equitable access to healthcare. Clinical trial data is extrapolated and used to make regulatory decisions, including drug approval, dosages,...

Oral Butyrate Supplementation Treats Pediatric Obesity

by Veronica Salib

According to the CDC, 20% of children and adolescents in the United States deal with pediatric obesity. Obesity is linked with high blood pressure, high cholesterol, type 2 diabetes, joint problems,...

Comparing Buprenorphine and Methadone for OUD During Pregnancy

by Veronica Salib

Data from the CDC suggests that 75% of overdoses in the United States involve opioids. It is abundantly clear to healthcare professionals that the rates of opioid use disorder (OUD) are rising —...

Improving Clinical Trial Diversity Through Community and Pharmaceutical Relationships

by Veronica Salib

In the United States and worldwide, clinical trials play a vital role in developing, testing, approving, and rolling out medical interventions. In the US, the FDA monitors and regulates clinical trials, using the results to decide whether...

FDA Approves ELAHERE for Ovarian Cancer

by Veronica Salib

The American Cancer Society states that ovarian cancer is the fifth leading cause of cancer-related death in women in the United States. The organization also says that, in 2022, nearly 13,000 people...

FDA Clears Clinical Trials on Investigational New Drug for ALS

by Veronica Salib

Amyotrophic lateral sclerosis, ALS, is a life-threatening neurodegenerative disease that can lead to paralysis and death. Over 5,000 individuals in the United States are diagnosed with ALS each year,...

Anticipating the 2023 Biosimilar Boom

by Veronica Salib

A recent analysis by Vantage Market Research found that in 2021 the global biosimilars market was valued at $28.46 billion. Projections based on market trajectory predict that the market will surpass $103.94 billion by 2028. While...

FDA Recommends New Asthma Rescue Treatment

by Veronica Salib

AstraZeneca and Avillion recently teamed up to develop PT027, an asthma rescue inhaler. PT027 is a pressurized metered-dose inhaler that delivers a fixed dose of two combined asthma medications,...

Citeline and Norstella Merger Creates $5B Pharmaceutical Technology Company

by Hayden Schmidt

Norstella, a leading pharmaceutical solutions provider, completed its merger with Citeline earlier this month. As a result of the merger, Citeline will join Norstella’s group of brands, including...

First Humans Transfused with Lab-Grown Blood

by Veronica Salib

According to an announcement by the NHS, the first humans have been transfused with lab-grown red blood cells as part of the RESTORE trial. The RESTORE trial is a randomized clinical trial in which red...

How to Integrate Remote Patient Monitoring Across Cancer Care Settings

by Veronica Salib

In recent years, remote patient monitoring tools have gained traction as they have been introduced and integrated into patient care. The uptick in the use of remote patient monitoring tools and platforms was driven, in part, by travel...

RSV Cases Flood Children’s Hospitals as Pfizer Announces Promising Vaccine

by Hayden Schmidt

After producing strong clinical trial results for its respiratory syncytial virus (RSV) vaccine, Pfizer says it is ending enrollment in its study and preparing to submit for FDA approval. The Phase 3...

US Department of Defense Grants $2.97 Million to Treventis

by Veronica Salib

According to a press statement released on October 18, 2022, the Treventis Corporation, a biotechnology company, was granted $2.97 million to research and develop an anti-tau misfolding drug. The press...

FDA Awards 19 Grants for Rare Disease Research

by Veronica Salib

On October 17, 2022, the FDA announced that its Orphan Products Grants Program has awarded 19 grants and 2 contracts, amounting to over $38 million, for rare disease research. This action will...