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Clinical Trial News

Northwell Health Joins RenovoRx's Phase III Trial for Pancreatic Cancer

  • Northwell Health Cancer Institute enrolls patients in RenovoRx's Phase III TIGeR-PaC trial for locally advanced pancreatic cancer (LAPC).
  • The trial assesses RenovoRx's TAMP therapy, comparing intra-arterial gemcitabine delivery via RenovoCath to standard intravenous chemotherapy.
  • RenovoRx anticipates completing patient enrollment in the TIGeR-PaC study during the first half of 2025.
  • The TAMP platform offers a novel approach that could potentially improve the risk-benefit profile compared to standard systemic chemotherapy.

EMA Implements Strategy to Expedite Drug Approvals in the EU

  • The EMA is implementing changes to streamline drug approval processes in the EU to address delays affecting patients and businesses.
  • In 2023, only 35% of marketing authorization applications (MAAs) were submitted on time, highlighting the need for improved predictability.
  • The EMA plans to enhance submission predictability and regulatory preparedness through intensified pre-submission interactions and revised Letters of Intent.
  • The agency aims to refine submission predictability by monitoring the impact of these measures and addressing recurring issues systematically.

Ascendis Pharma's Yorvipath Commercially Available in the US, Offering New Hope for Hypoparathyroidism

  • Ascendis Pharma has launched Yorvipath (palopegteriparatide) in the US, the first FDA-approved treatment for hypoparathyroidism in adults.
  • Yorvipath is a once-daily prodrug of parathyroid hormone, designed to provide continuous exposure to active PTH over 24 hours.
  • Ascendis has established a dedicated support program to assist patients with clinical education, access, and injection training.
  • Clinical trials demonstrated that 93% of YORVIPATH-treated patients achieved independence from both active vitamin D and therapeutic doses of elemental calcium.

Puma Biotechnology Initiates Phase II Trial of Alisertib for HR+/HER2- Metastatic Breast Cancer

• Puma Biotechnology has commenced the ALISCA™-Breast1 Phase II trial to evaluate alisertib combined with endocrine therapy for HR+/HER2- metastatic breast cancer. • The trial aims to determine the optimal dose of alisertib in combination with endocrine therapy, enrolling up to 150 patients in a randomized 1:1:1 design. • The primary endpoints include objective response rate, duration of response, disease control rate, progression-free survival, and overall survival. • Puma plans to engage with global regulatory agencies regarding the design of a pivotal Phase III trial based on the outcomes of the Phase II trial.

Evaluating how well and how safely Alisertib works with hormone therapy in treating patients with breast cancer that has come back or spread (hormone receptor positive, HER2 negative

2024-511497-79-00RecruitingPhase 2
Puma Biotechnology Inc.
Posted 11/19/2024

IVC Filter Safety Data Transparency Questioned in New Analysis

  • A recent analysis highlights concerns regarding the safety data of inferior vena cava (IVC) filters, devices implanted to prevent blood clots.
  • The analysis points to potential flaws in the clinical trial design that may have obscured critical safety issues with the IVC filter.
  • Lack of transparency from both the FDA and device manufacturers regarding safety data raises concerns about patient safety and informed consent.

BioVie's Bezisterim to Enter Phase 2 Trial for Long COVID Treatment

  • BioVie Inc. will present the design of its Phase 2 trial of bezisterim for Long COVID at the Demystifying Long COVID International Conference.
  • The Phase 2 study is a double-blind, randomized, placebo-controlled, multicenter trial involving approximately 200 patients.
  • Bezisterim's efficacy in reducing neurocognitive symptoms associated with Long COVID will be evaluated over a 3-month treatment period.
  • The trial is fully funded by a $13.1 million grant from the U.S. Department of Defense.

RenovoRx Advances TIGeR-PaC Trial for Pancreatic Cancer with Novel TAMP Therapy

  • RenovoRx's TIGeR-PaC Phase III trial evaluates TAMP therapy for locally advanced pancreatic cancer, aiming to improve survival and reduce side effects.
  • SCRI Oncology Partners has initiated patient enrollment, expanding the trial's reach across a network of over 250 locations in the U.S.
  • Pharmacokinetic data presented at ASCO GI 2025 supports TAMP's potential to enhance local drug potency while minimizing systemic exposure to gemcitabine.
  • RenovoRx anticipates completing patient enrollment and the second interim analysis for the TIGeR-PaC trial by the first half of 2025.

Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC

NCT03257033RecruitingPhase 3
RenovoRx
Posted 3/12/2018

Precision for Medicine and Agena Bioscience Partner to Enhance Mutation Detection in Lung Tumors

  • Precision for Medicine and Agena Bioscience collaborate to improve mutation detection in lung tumor samples using MassARRAY® technology.
  • The study identified actionable mutations in 40% of lung tumor samples previously deemed insufficient by NGS platforms.
  • MassARRAY® system showed a significantly lower failure rate of 2% compared to the 22% observed with NGS platforms.
  • The collaboration aims to accelerate research and development of targeted therapies by providing faster and more cost-effective mutation profiling.

Medtronic's Smart MDI System Receives FDA Clearance for Enhanced Insulin Dosing

  • Medtronic's Smart MDI system, featuring the InPen™ app and Simplera™ CGM, has received FDA clearance, marking a significant advancement in diabetes management.
  • The system is the first to offer real-time, personalized insights and correction recommendations for missed or inaccurate insulin doses, addressing a critical unmet need.
  • The Smart MDI system aims to reduce the guesswork in diabetes management, helping to maintain stable blood sugar levels and reduce long-term complications for MDI users.
  • Medtronic plans a limited market release of the Smart MDI system, starting with existing CGM and InPen™ customers, followed by a broader commercial launch.

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