BAYLOR COLLEGE OF MEDICINE
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Private
- Established
- 1900-10-30
- Employees
- 10K
- Market Cap
- -
- Website
- http://www.bcm.edu
Kennedy Mandates Placebo Testing for All New Vaccines, Potentially Impacting Fall COVID Boosters
• U.S. Health and Human Services Secretary Robert F. Kennedy Jr. has announced that all new vaccines must undergo placebo-controlled safety trials before approval, described as a "radical departure" from past practices.
• The mandate could significantly impact the availability of updated COVID-19 booster shots expected for fall, which have typically been authorized without human trials when targeting new viral strains.
• Kennedy simultaneously announced an initiative for the NIH to accelerate development of new vaccines for COVID, bird flu, and seasonal flu using technologies other than mRNA, reflecting his long-standing criticism of vaccine oversight.
FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval
• The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022.
• Interim results from a phase 2/3 study showed Novavax's updated XBB.1.5 variant vaccine generated 5.8 times higher neutralizing antibody levels compared to the original formulation, with a favorable safety profile.
• The FDA's request represents a significant setback for Novavax, which had expected approval based on prior conversations with regulators and had already passed its April 1 PDUFA date.
Varenicline Shows Promising Results for Youth Vaping Cessation in Landmark Trial
• A groundbreaking clinical trial reveals varenicline combined with remote behavioral counseling achieved 51% vaping abstinence rates in youth compared to 14% with placebo during the final four weeks of treatment.
• The study, published in JAMA, is the first pharmacotherapy trial for nicotine vaping cessation specifically targeting individuals aged 16-25, addressing a critical gap in treatment options for this vulnerable population.
• Despite some adverse events like nausea and vivid dreams, varenicline was generally well-tolerated, offering a potential evidence-based intervention for the 7.8% of high school students and 24.1% of young adults who reported recent e-cigarette use.
Hawaii Advances Psychedelic-Assisted Therapy Research Bill with $4 Million Funding Potential
• Hawaii's House Finance Committee unanimously approved a Senate-passed bill establishing a two-year pilot program for psychedelic-assisted therapy research, potentially providing $4 million in combined public-private funding.
• The legislation would create a "mental health emerging therapies special fund" under the Office of Wellness and Resilience to support clinical trials and establish research partnerships for treatments targeting PTSD, depression, and other mental health conditions.
• The initiative positions Hawaii to potentially lead national efforts in psychedelic medicine, with strong support from veterans' organizations and mental health advocates who cite promising clinical trial results for MDMA and psilocybin therapies.
Election-Related Stress Reaches Critical Levels Among Americans, APA Survey Reveals
• A new American Psychological Association poll reveals 77% of Americans report stress about the nation's future, with 69% specifically worried about the upcoming presidential election.
• Election-related anxiety transcends political divides, with similar stress levels reported among Republicans (80%), Democrats (79%), and Independents (73%), reflecting widespread concern about potential post-election violence.
• Mental health experts recommend practical coping strategies including limiting media exposure, focusing on controllable actions like voting, and maintaining healthy routines to manage election-related stress.
FDA Delays Moderna's Combination Flu-COVID Vaccine Amid Increased Regulatory Scrutiny
• Moderna's combination flu-COVID vaccine faces FDA delay until 2026, as regulators now require Phase 3 flu efficacy data before approval, signaling potentially heightened scrutiny for vaccine developers.
• The regulatory setback comes amid growing concerns about anti-vaccine sentiment within government, with some states introducing legislation to restrict or ban mRNA-based vaccines despite their established safety profile.
• If eventually approved, Moderna's mRNA-1083 would be the first vaccine in the US to offer protection against both flu and COVID-19 in a single shot, potentially improving vaccination rates through increased convenience.
Perimeter Medical Submits FDA Premarket Approval for AI-Enabled OCT System in Breast Cancer Surgery
• Perimeter Medical Imaging AI has submitted a Premarket Approval application to the FDA for its B-Series OCT system with ImgAssist AI 2.0 technology for use during breast-conserving surgeries.
• The system demonstrated statistically significant reduction in patients with residual cancer during surgery in a pivotal clinical trial involving 206 breast cancer patients, potentially lowering reoperation rates.
• If approved, the technology could address the current challenge where approximately 1-in-5 breast cancer surgeries require repeat procedures due to positive margins, offering surgeons real-time tissue assessment capabilities.
First Hormone-Free Male Birth Control Pill Shows 99% Efficacy in Preclinical Studies
• YourChoice Therapeutics' novel contraceptive YCT-529, targeting retinoic acid receptor-alpha, demonstrated 99% effectiveness in mice and successfully reduced sperm counts in non-human primates.
• The drug achieved full fertility reversal within 6 weeks in mice and 10-15 weeks in primates after discontinuation, with no observed side effects in either species.
• Currently in Phase 1b/2a clinical trials, YCT-529 represents a significant advancement in male contraception options, which have historically been limited to condoms and vasectomy.
Greenwich LifeSciences Reports 46% HLA-A*02 Prevalence in FLAMINGO-01 Trial for Breast Cancer Vaccine
• Initial analysis of FLAMINGO-01 trial reveals 46% of screened patients carry at least one HLA-A*02 allele, a crucial factor for GLSI-100 breast cancer vaccine treatment.
• The trial's open-label arm studying non-HLA-A*02 patients has been expanded from 100 to 250 participants following FDA and EMA approval.
• The Phase III trial design includes approximately 500 HLA-A*02 positive patients in randomized arms, with an additional open-label arm to investigate vaccine efficacy in other HLA types.
Jaguar Health Advances Crofelemer Trials for Rare Diarrheal Diseases
• Jaguar Health has initiated multiple clinical trials to evaluate crofelemer for treating rare diarrheal diseases, including Short Bowel Syndrome with Intestinal Failure (SBS-IF) and Microvillus Inclusion Disease (MVID).
• Crofelemer, a plant-based drug, has received Orphan Drug Designation from the FDA and EMA for both SBS-IF and MVID, potentially expediting its development and market access.
• Clinical trials include investigator-initiated studies and Phase 2 trials across the US, EU, and MENA regions, with initial proof-of-concept results expected as early as H1 2025.
• These trials aim to address unmet needs in treating severe diarrhea and malabsorption in pediatric and adult patients, potentially leading to reimbursed early patient access in certain EU countries.
Error parsing response
Error occurred while parsing the model response.
MB-105, a CD5-Targeted CAR-T Cell Therapy, Receives FDA Orphan Drug Designation for T-Cell Lymphoma
• March Biosciences' MB-105, a first-in-class CD5 CAR-T cell therapy, has received FDA Orphan Drug Designation for relapsed/refractory CD5-positive T-cell lymphoma.
• The Orphan Drug Designation provides incentives including tax credits, user fee exemptions, and seven years of market exclusivity post-approval.
• MB-105 demonstrated a 44% overall response rate in T-cell lymphoma patients in a Phase 1 trial, showing promising safety and efficacy signals.
• March Biosciences is preparing to advance MB-105 to a Phase 2 clinical trial in early 2025 to further evaluate its potential.
Pfizer-BioNTech COVID-Flu Combo Vaccine Faces Setback Due to Influenza B Response
• Phase 3 trial of Pfizer-BioNTech's combined COVID-19 and influenza mRNA vaccine reveals suboptimal antibody response for influenza B component, necessitating formula adjustments.
• The 8,000-subject study aimed to demonstrate non-inferiority to existing Comirnaty COVID-19 vaccine and standard flu vaccines, following promising phase 1/2 results.
• Setback potentially opens opportunity for Moderna, whose competing COVID-flu combination vaccine showed superior immune responses in Phase 3 trials, targeting potential approval by 2025-2026.
© Copyright 2025. All Rights Reserved by MedPath