University of Alberta

FDA Overhauls COVID-19 Vaccine Approval Process, Limiting Access for Healthy Adults and Children

2 days ago

• The FDA has announced major changes to COVID-19 vaccine approvals, requiring placebo-controlled clinical trials for shots intended for healthy adults and children, effectively ending routine annual approvals for these groups. • Under the new framework, COVID-19 vaccines will remain readily available through streamlined approvals only for adults 65 and older and those with health conditions that increase risk of severe COVID-19. • The policy shift, spearheaded by FDA Commissioner Marty Makary and vaccine chief Vinay Prasad, represents a significant departure from the previous "one-size-fits-all" approach to COVID-19 vaccination recommendations.

University of Alberta's Novel Cancer Drug Zelenirstat Receives FDA Fast-Track Designation

3 months ago

• University of Alberta researchers have developed Zelenirstat, an innovative oral cancer medication that works by preventing cancer cell spread and starving tumors. • The FDA has granted fast-track designation to Zelenirstat, potentially accelerating its development and review process for cancer treatment. • This breakthrough represents a significant advance in cancer therapy, offering patients a convenient at-home treatment option compared to traditional cancer therapies.

FDA Approves Bayer/Merck & Co Heart Failure Drug Verquvo

4 months ago

The FDA has approved Bayer and Merck & Co's heart failure drug, Verquvo (vericiguat), for reducing the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure and ejection fraction less than 45%. This approval introduces a new option in a competitive market, following the results of the pivotal phase 3 VICTORIA trial.

Ruxolitinib Cream Shows Promise in Pediatric Atopic Dermatitis and Vitiligo Treatment: SPD 2024 Findings

5 months ago

• Phase 3 trial results demonstrate 1.5% ruxolitinib cream's safety and efficacy in treating atopic dermatitis in children aged 2-11 years, with no significant hematologic concerns noted. • Clinical studies TRuE-V1 and TRuE-V2 show significant skin repigmentation in adolescents with vitiligo after 52 weeks of twice-daily ruxolitinib cream application. • The Society for Pediatric Dermatology 2024 conference highlighted advances in non-steroidal topical therapies, including roflumilast and clascoterone, addressing treatment challenges in pediatric dermatology.

MedMira's Reveal G4 Rapid HIV-1/2 Test Approved by Health Canada for Point-of-Care Use

5 months ago

• MedMira's Reveal G4 Rapid HIV-1/2 Test receives Health Canada approval for point-of-care use, offering fast and reliable results. • The Reveal HIV test boasts a sensitivity of 99.64% and a specificity of 99.71%, suitable for various healthcare settings. • This rapid test accurately detects HIV-1/2 antibodies from a finger prick sample in under a minute, with no special storage needed. • Approval follows a surge in new HIV diagnoses in Canada, highlighting the need for accessible and efficient testing solutions.

Stem Cell Transplant Reverses Type 1 Diabetes in World-First Clinical Trial

8 months ago

• A 25-year-old Chinese woman with type 1 diabetes achieved insulin independence after receiving a stem cell transplant, marking a potential breakthrough in diabetes treatment. • The patient's own cells were reprogrammed into induced pluripotent stem cells (iPSCs) and then differentiated into functional islet cells, which were transplanted into her abdomen. • Following the transplant, the patient's blood sugar levels stabilized, and she no longer required insulin injections, maintaining a non-diabetic glycemic range for over a year. • This success builds on previous stem cell research for both type 1 and type 2 diabetes, offering hope for personalized cell therapies to treat this chronic condition.

Anti-Obesity Drugs Show Promise in Young Children, but Long-Term Effects Remain Unknown

8 months ago

• A recent study shows that liraglutide, a GLP-1 mimic, led to a BMI decrease in children aged 6-11, offering a potential treatment for early-onset obesity. • While trials indicate significant weight loss in adolescents using drugs like semaglutide and liraglutide, concerns persist regarding long-term impacts on growth and puberty. • Experts emphasize the need for diverse studies and prolonged monitoring to address ethical considerations and potential side effects in young children using GLP-1 mimics. • The use of BMI as a metric for measuring progress has disadvantages, and weight-related health problems should be considered.

Tonix Pharmaceuticals Presents Promising Data on Mpox Vaccine Candidate TNX-801

8 months ago

• Tonix Pharmaceuticals' TNX-801, a horsepox-based vaccine, demonstrates efficacy in protecting animals against lethal mpox challenge, supporting its potential as a single-dose mpox vaccine. • New data indicates improved tolerability of TNX-801 in immunocompromised animals, with no evidence of spread to blood or tissues, even at high doses, suggesting a favorable safety profile. • TNX-801's single-dose regimen and stability at standard temperatures offer advantages over existing mpox vaccines, potentially facilitating widespread use, especially in resource-limited settings. • Tonix's synthetic horsepox vaccine platform has been selected by NIH’s Project NextGen for clinical testing, highlighting its potential in combating emerging infectious diseases like COVID-19.

University of Minnesota Trial Finds Hydroxychloroquine No Better Than Placebo in Preventing COVID-19

5 years ago

A University of Minnesota trial has concluded that hydroxychloroquine is no more effective than a placebo in preventing COVID-19 after exposure, with 40% of participants experiencing non-serious side effects.