Georgetown University
🇬🇹Guatemala
- Country
- 🇬🇹Guatemala
- Ownership
- Private
- Established
- 1789-01-23
- Employees
- 5K
- Market Cap
- -
- Website
- http://www.georgetown.edu
FDA Overhauls COVID-19 Vaccine Approval Process, Limiting Access for Healthy Adults and Children
• 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.
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.
NIH Funding Cuts Under Trump Administration Threaten Early-Stage Biopharma Innovation
• The Trump administration has implemented a $4 billion reduction in NIH overhead funding, cutting indirect cost rates to 15% and disrupting grant review processes for biomedical research.
• NIH SBIR and STTR grants for innovative drug development totaled $1.4 billion between 2020-2025, with over 80% supporting crucial preclinical and discovery stage research.
• Recent policy changes, including funding freezes and increased scrutiny of grant applications, could significantly impact biotech startups and delay global drug development efforts.
Jupiter Neurosciences Advances JOTROL Platform with Phase 2a Parkinson's Trial and Consumer Product Launch
• Jupiter Neurosciences has secured strategic partnerships with Zina Biopharmaceuticals and Catalent Pharma Solutions to advance JOTROL, their enhanced resveratrol formulation, into Phase 2a trials for Parkinson's disease.
• The company's JOTROL platform demonstrates nine times higher bioavailability compared to traditional resveratrol formulations, addressing a key limitation in previous clinical applications of the compound.
• With $1.76 million in NIH funding secured and $16 million under review, Jupiter plans multiple Phase 2 trials across CNS disorders while preparing for a direct-to-consumer product launch in 2025.
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Taletrectinib Approved in China for ROS1-Positive NSCLC, Showing Promise in TKI-Pretreated and Naive Patients
• China's NMPA has approved taletrectinib for treating adults with locally advanced or metastatic ROS1-positive NSCLC previously treated with ROS1 TKIs.
• The approval was based on the phase 2 TRUST-I trial, which demonstrated a 51.5% ORR in patients pretreated with crizotinib, with a median DOR of 10.6 months.
• Taletrectinib has also received priority review for first-line treatment of ROS1-positive NSCLC, supported by data showing a 90.6% ORR in TKI-naive patients.
• Clinical trials show taletrectinib's efficacy in CNS penetration and activity against resistance mutations, offering a potential best-in-class safety profile.
Nilotinib Shows Promise in Phase 2 Trial for Dementia with Lewy Bodies
• A phase 2 trial of nilotinib in patients with Dementia with Lewy Bodies (DLB) showed promising cognitive benefits over a 6-month period.
• Patients treated with nilotinib demonstrated a statistically significant improvement on the Alzheimer’s Disease Assessment Scale-Cognition 14.
• The study reported that nilotinib was safe and well-tolerated, with fewer adverse events compared to the placebo group.
• Nilotinib's mechanism involves inducing autophagy and reducing inflammation in the brain, potentially addressing both cognitive and motor symptoms of DLB.
Trump Administration Reshapes Health Agencies; FDA Approves Novel Cancer Therapies
• President-elect Trump nominates Robert F. Kennedy Jr. as HHS Secretary, Mehmet Oz to lead CMS, and Marty Makary to head the FDA, signaling a shift in healthcare priorities.
• The FDA grants accelerated approval to asciminib for chronic myeloid leukemia and obecabtagene autoleucel for B-cell acute lymphoblastic leukemia, marking advancements in cancer treatment.
• Revumenib receives approval for relapsed or refractory acute leukemia with KMT2A translocation, offering a targeted therapy for this specific genetic alteration.
• A new Surgeon General's report highlights disparities in tobacco use, emphasizing the need for tailored interventions in vulnerable populations.
Shuttle Pharma's Ropidoxuridine Phase 2 Trial Expands for Glioblastoma Treatment
• Shuttle Pharma expands its Phase 2 clinical trial of Ropidoxuridine for glioblastoma, with the first patient dosed at UVA Cancer Center.
• The trial includes 40 patients initially, randomized to two doses, followed by 14 more at the optimal dose, targeting IDH wild-type, methylation-negative glioblastoma.
• Ropidoxuridine, a radiation sensitizer, aims to improve outcomes when combined with radiation therapy, addressing a critical unmet need in aggressive brain tumors.
• The FDA has granted Ropidoxuridine Orphan Drug Designation, potentially providing market exclusivity upon approval, enhancing its commercial prospects.
FDA Approves Astellas' Vyloy (Zolbetuximab) for Advanced Gastric and GEJ Adenocarcinoma
• The FDA has approved zolbetuximab (Vyloy) in combination with chemotherapy for first-line treatment of CLDN18.2-positive, HER2-negative gastric or GEJ adenocarcinoma.
• Approval was based on SPOTLIGHT and GLOW trials, demonstrating statistically significant improvements in progression-free and overall survival compared to chemotherapy alone.
• The VENTANA CLDN18 (43-14A) RxDx Assay from Roche was also approved as a companion diagnostic to identify patients eligible for Vyloy treatment.
• Vyloy is now approved in five markets worldwide, offering a new targeted therapy option for a subset of gastric and GEJ cancer patients.
Perioperative Nivolumab and Neoadjuvant Immunotherapy Show Promise in Resectable NSCLC
• Perioperative nivolumab significantly extends event-free survival (EFS) in resectable non-small cell lung cancer (NSCLC), with a median EFS increase from 17.0 to 40.1 months.
• Neoadjuvant nivolumab, alone or with ipilimumab, demonstrates durable long-term survival benefits, particularly in patients achieving major pathological response (MPR) or pathological complete response (PCR).
• Circulating tumor DNA (ctDNA) clearance during neoadjuvant therapy is a potential biomarker, with higher clearance rates observed in patients receiving nivolumab and correlating with improved outcomes.
• Biomarker analysis suggests PD-L1 positivity may predict better EFS with nivolumab monotherapy, while KRAS co-mutations may benefit more from nivolumab plus ipilimumab combination therapy.
Perioperative Nivolumab and Neoadjuvant Immunotherapy Show Promise in Resectable NSCLC
• Perioperative nivolumab significantly extends event-free survival (EFS) in resectable NSCLC, with a median EFS increase from 17.0 to 40.1 months.
• Neoadjuvant nivolumab, alone or with ipilimumab, demonstrates durable long-term survival benefits, particularly in patients achieving major pathological response (MPR) or pathological complete response (PCR).
• Circulating tumor DNA (ctDNA) clearance during neoadjuvant therapy is a potential biomarker, with higher clearance rates observed in the nivolumab group and correlation with PCR achievement.
• Biomarker analysis suggests PD-L1 positivity may predict better EFS with nivolumab monotherapy, while KRAS co-mutations may benefit more from nivolumab plus ipilimumab.
Ivonescimab Monotherapy Shows Significant PFS Improvement in NSCLC
• Ivonescimab monotherapy reduced the risk of disease progression or death by 49% compared to pembrolizumab in PD-L1 positive advanced NSCLC patients.
• The HARMONi-2 trial demonstrated a median progression-free survival of 11.14 months with ivonescimab versus 5.82 months with pembrolizumab.
• Summit Therapeutics plans to initiate the HARMONi-7 Phase III trial in early 2025, focusing on first-line PD-L1 high advanced NSCLC.
• Phase II data of ivonescimab in perioperative NSCLC showed encouraging major pathological response and pathological complete response rates.
Summit Therapeutics Completes Enrollment in Phase III HARMONi Trial and Receives FDA Fast Track Designation for Ivonescimab
• Summit Therapeutics has completed enrollment in the Phase III HARMONi trial evaluating ivonescimab plus chemotherapy for EGFR-mutated NSCLC after TKI failure.
• The FDA granted Fast Track designation to ivonescimab in combination with platinum-based chemotherapy for EGFR-mutated NSCLC post EGFR-TKI therapy.
• HARMONi is a multi-regional trial conducted in North America, Europe, and China, with topline data expected in mid-2025.
• Ivonescimab, a bispecific antibody targeting PD-1 and VEGF, has shown promise in clinical trials, including HARMONi-2 where it outperformed pembrolizumab.
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.
Long-term efficacy and safety of iptacopan in PNH with anaemia
The article discusses the long-term efficacy and safety of iptacopan, a treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH) with anaemia, as presented by Prof. Antonio Risitano from the University of Naples, Italy.
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