Harvard Medical School
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Private, Subsidiary
- Established
- 1782-09-19
- Employees
- 10K
- Market Cap
- -
- Website
- http://www.hms.harvard.edu
Vitamin D Supplementation Shown to Slow Biological Aging in Landmark VITAL Trial
• A randomized controlled trial reveals vitamin D supplementation helps maintain telomeres, protective chromosome caps that shorten during aging, effectively preventing nearly three years of biological aging.
• The VITAL trial, the first large-scale long-term study of its kind, demonstrated that daily vitamin D3 (2,000 IU) significantly reduced telomere shortening over four years compared to placebo.
• Researchers note these findings align with previous VITAL results showing vitamin D benefits in reducing inflammation and lowering risks of advanced cancer and autoimmune disease.
FDA Convenes Expert Panel to Evaluate Talc Safety in Food and Drugs
• The FDA announced on May 16, 2025, that it will host its first independent scientific expert panel to evaluate potential health risks associated with talc in food and pharmaceutical products.
• The panel will specifically examine concerns regarding inflammation and cancer risks linked to hydrous magnesium silicate (talc), following voluntary removal of the mineral by some manufacturers.
• This regulatory review comes amid growing scientific scrutiny of talc safety, with the FDA seeking comprehensive information about the common mineral's health implications across multiple product categories.
CRISPR Therapeutics Expands into siRNA Therapies with $95M Sirius Partnership for Thromboembolic Disorders
• CRISPR Therapeutics is diversifying beyond gene editing through a strategic $95 million partnership with Sirius Therapeutics to develop SRSD107, a long-acting siRNA therapy targeting Factor XI for thromboembolic disorders.
• In Phase 1 trials, SRSD107 demonstrated impressive efficacy with over 93% reduction in Factor XI levels and doubled blood clotting time, with effects lasting up to six months from a single dose.
• The collaboration includes a 50-50 cost and profit-sharing structure for SRSD107 development, with CRISPR leading U.S. commercialization and retaining rights to license two additional siRNA targets.
Precision Medicine Breakthrough Shows 2.6-Fold Survival Improvement in Deadly Canine Cancer
• FidoCure and Stanford researchers have published groundbreaking findings showing targeted therapies significantly improve survival rates in dogs with splenic hemangiosarcoma, the deadliest canine cancer.
• The study of 508 dogs revealed that precision medicine approaches led to a 1.8-fold improvement in median survival compared to surgery alone, increasing to 2.6-fold when combined with chemotherapy.
• Researchers identified specific genetic mutations like NRAS that indicate less aggressive cancer subtypes, enabling more personalized treatment plans and potentially informing human angiosarcoma therapies.
Baebies Secures FDA Breakthrough Designation for First Point-of-Care Heparin Monitoring Test
• Baebies' Anti-Factor Xa test on the FINDER® platform has received FDA Breakthrough Device Designation, offering heparin monitoring results in under 15 minutes from just 50 µL of whole blood.
• The point-of-care test addresses critical delays in heparin management, particularly important in high-risk settings like ECMO where mortality rates reach 50% and bleeding complications affect over one-third of patients.
• Unlike traditional methods that require lab processing and over an hour for results, the FINDER test needs no centrifugation and can be performed directly at the point of care, potentially transforming time-sensitive anticoagulation management.
Pykus Therapeutics Completes Enrollment for Novel Retinal Detachment Treatment Trial
• Pykus Therapeutics has completed enrollment for its PYK-2101 pilot study in Australia, testing a first-in-class biodegradable retinal hydrogel sealant for retinal detachment surgery.
• The innovative treatment aims to eliminate the need for post-operative face-down positioning and intraocular gas, potentially transforming patient recovery and surgical outcomes.
• The company plans to submit an Investigational Device Exemption application to the FDA in Q4 2025 for a U.S. pivotal trial, with interim study results expected in Q2 2025.
Low-Dose Apixaban Proves Effective and Safer for Extended Cancer-Related VTE Prevention
• The API-CAT trial demonstrated that reduced-dose apixaban (2.5mg twice daily) was noninferior to full-dose (5mg twice daily) for preventing recurrent venous thromboembolism in cancer patients requiring extended anticoagulation.
• Patients receiving the lower dose experienced significantly fewer bleeding events (12.1% vs 15.6%) while maintaining similar protection against blood clots, potentially changing clinical practice guidelines for cancer-associated thrombosis management.
• The findings are particularly significant as cancer patients live longer with improved treatments but face ongoing thrombosis risks, offering clinicians a safer option for long-term anticoagulation beyond the initial 6-month treatment period.
Novel Chemo-Immunotherapy Approach Shows Promise for Advanced HPV-Negative Head and Neck Cancer
• A Phase 2 clinical trial at UChicago Medicine demonstrated that combining nivolumab immunotherapy with chemotherapy led to tumor shrinkage in 53% of advanced HPV-negative head and neck cancer patients.
• The innovative treatment approach, which included response-adaptive chemo-radiation therapy, showed improved survival outcomes and reduced toxic side effects, particularly in patients who responded well to initial treatment.
• Higher PD-L1 expression levels were associated with better treatment responses, suggesting its potential as a biomarker for predicting treatment outcomes in this patient population.
Tambiciclib-Zanubrutinib Combo Shows 67% Response Rate in Relapsed/Refractory DLBCL Trial
• Phase 2a trial demonstrates promising 67% overall response rate for tambiciclib plus zanubrutinib combination in relapsed/refractory DLBCL patients, including one complete response.
• The combination therapy showed particularly strong efficacy in ABC DLBCL subtype patients, achieving an 83% disease control rate with 4 responses and 1 stable disease out of 6 patients.
• Safety profile reveals grade 3 or higher adverse effects in 55.6% of patients, while genetic analysis indicates efficacy independent of MYD88 or CD79B mutations.
Novel Gene-Silencing Therapy Shows Promise for Long-Term Cholesterol Control with Single Dose
• Groundbreaking epigenetic editing technique demonstrates over 98% reduction in PCSK9 levels and 70% decrease in LDL cholesterol through a single treatment in preclinical studies.
• The novel PCSK9-epigenetic editor (PCSK9-EE) therapy maintains its effectiveness for over a year without permanently altering DNA, offering a potential alternative to daily cholesterol medications.
• Research in non-human primates shows promising safety profile with only transient liver enzyme elevations, while maintaining the ability to reverse the treatment if needed.
Personalized Cancer Vaccine Shows Promising Results in Advanced Kidney Cancer Trial
• A groundbreaking Phase 1 trial at Yale Cancer Center demonstrated successful anti-cancer immune responses in all nine patients with advanced kidney cancer using personalized therapeutic vaccines.
• The vaccine, designed to target specific tumor mutations, generated strong T-cell responses within three weeks of treatment and maintained effectiveness for approximately three years post-treatment.
• Patients experienced minimal side effects, primarily mild flu-like symptoms, suggesting a favorable safety profile for this innovative approach to treating advanced clear cell renal cell carcinoma.
Cabozantinib Shows Promise in Advanced GI Neuroendocrine Tumors
• Cabozantinib (Cabometyx) significantly improved progression-free survival (PFS) in patients with advanced gastrointestinal neuroendocrine tumors (GI-NETs) after prior therapy.
• The CABINET trial subgroup analysis revealed a median PFS of 8.5 months with cabozantinib versus 5.6 months with placebo in GI-NET patients.
• Benefits were observed across various clinical factors, including tumor grade and prior treatment, except in non-midgut GI primary tumors.
• The safety profile of cabozantinib was consistent with previous data, with manageable adverse events reported.
Datopotamab Deruxtecan's Role in HR+/HER2- Breast Cancer Treatment: Sequencing and Safety Considerations
• Datopotamab deruxtecan (Dato-DXd) is poised to become a standard treatment for metastatic hormone receptor-positive, HER2-negative breast cancer after prior systemic therapy.
• Optimal sequencing of antibody-drug conjugates (ADCs) like Dato-DXd, sacituzumab govitecan, and trastuzumab deruxtecan remains uncertain, especially considering overlapping toxicities.
• Real-world toxicity profiles suggest sacituzumab govitecan may cause more cytopenias and diarrhea, while Dato-DXd and trastuzumab deruxtecan are linked to interstitial lung disease.
• The lack of overall survival difference in the TROPION-Breast01 trial raises questions about efficacy issues or the impact of crossover between treatment arms.
Gastrointestinal Cancer Symposium 2025: Key Advances in Treatment Strategies
• Nivolumab plus ipilimumab demonstrates superior progression-free survival compared to nivolumab alone in MSI-H/dMMR metastatic colorectal cancer.
• Encorafenib combined with cetuximab and chemotherapy shows significant improvement in overall response rate for BRAF V600E-mutated metastatic colorectal cancer.
• TACE plus camrelizumab and rivoceranib extends progression-free survival in patients with unresectable hepatocellular carcinoma, offering a manageable safety profile.
Eirion Therapeutics' ET-02 Shows Promise in Phase 1 Trial for Androgenic Alopecia
• Eirion Therapeutics announced positive results from its first-in-man clinical trial of topical ET-02 for androgenic alopecia.
• The Phase 1 trial demonstrated that ET-02 was safe and well-tolerated among participants.
• Early results indicated that improvements were observed as early as 5 weeks into the treatment.
• The 5% dosage of ET-02 showed a significant increase in non-vellus hair count, marking a potential breakthrough in hair loss treatment.
ImmunoGen's ELAHERE Receives Accelerated FDA Approval for Ovarian Cancer Treatment
ImmunoGen, Inc. has achieved accelerated FDA approval for its ovarian cancer drug ELAHERE, targeting patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. This marks a significant advancement in treatment options for patients with limited alternatives.
Breakthroughs in Clinical Trials: A Week of Promising Developments
This week's clinical trials round-up highlights significant advancements in treatments for various conditions, including idiopathic pulmonary fibrosis, diabetes, COPD, and advanced solid tumours. Key developments include positive Phase 2 results for Faron Pharmaceuticals' BEXMAB trial, AstraZeneca's Phase 2a COURSE trial for COPD, and Johnson & Johnson's Phase 3 QUASAR maintenance study for ulcerative colitis.
Tiziana Life Sciences Advances Foralumab for MS and SCI Treatment
• Tiziana Life Sciences is expanding its Phase 2 trial of intranasal foralumab for non-active secondary progressive multiple sclerosis (na-SPMS) to include more prestigious U.S. medical centers.
• The company announced the discovery of new immune biomarkers in patients with na-SPMS treated with nasal foralumab, enhancing understanding of the drug's mechanism.
• Preclinical studies show that nasal anti-CD3 treatment, foralumab, led to notable advancements in motor functions in models with spinal cord injury (SCI).
• Tiziana Life Sciences has dosed additional patients in its Expanded Access Program for na-SPMS, with early data showing disease stabilization or improvement.
Semaglutide Shows Promise in Reducing Alcohol Consumption and Cravings
• A new study reveals that semaglutide, known as Ozempic and Wegovy, significantly reduces alcohol cravings and consumption in individuals with alcohol use disorder.
• Participants on semaglutide experienced fewer heavy drinking days and decreased alcohol intake during lab tests compared to those on a placebo, indicating potential therapeutic benefits.
• The research suggests semaglutide's effects on alcohol cravings may surpass existing treatments, offering a promising avenue for addressing the unmet needs in alcohol use disorder.
• Further studies are warranted to explore semaglutide's long-term efficacy, optimal dosages, and safety, particularly for individuals without obesity or diabetes.
ESMO 2024: New Leadership and Groundbreaking Developments in Oncology Research and Patient Care
• ESMO President Prof Andres Cervantes highlights the organization's evolution into a comprehensive support network for oncologists, announcing new initiatives including AI & Digital Oncology Congress 2025.
• Significant advances in oncofertility research reveal pregnancy after breast cancer is feasible, leading to new fertility preservation laws and guidelines for cancer patients.
• Whole Genome Sequencing emerges as a transformative tool in personalized cancer care, with Prof Serena Nik-Zainal demonstrating its potential for identifying unique mutational signatures in individual tumors.
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