Clinical Trial News
FDA Accepts Resubmission of NDA for Oral Sulopenem in Uncomplicated UTIs
- The FDA has accepted Iterum Therapeutics' resubmitted New Drug Application (NDA) for oral sulopenem for treating uncomplicated urinary tract infections (uUTIs).
- The FDA has granted a Prescription Drug User Fee Act (PDUFA) action date of October 25, 2024, for oral sulopenem.
- The resubmission includes data from the REASSURE clinical trial, which demonstrated oral sulopenem's non-inferiority and statistically significant superiority compared to Augmentin®.
- Oral sulopenem, if approved, could provide a much-needed treatment option for adult women with uUTIs caused by multi-drug resistant pathogens.
Novartis' Scemblix Demonstrates Superior Efficacy in Newly Diagnosed CML Patients
- The Phase III ASC4FIRST trial showed Scemblix achieved a 67.7% major molecular response (MMR) rate at week 48, significantly outperforming standard-of-care TKIs.
- Scemblix demonstrated a favorable safety profile with fewer Grade 3 or worse adverse events compared to standard-of-care treatments like imatinib.
- Novartis plans to submit the ASC4FIRST data to the FDA for review under the Oncology Center of Excellence Real-Time Oncology Review program.
- Scemblix represents a promising first-line treatment option for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia patients.
Highlighted Clinical Trials:
Novartis Pharmaceuticals
Posted 5/25/2021
Novartis Pharmaceuticals
Posted 10/26/2017
Novartis Pharmaceuticals
Posted 10/6/2021
Novartis Pharmaceuticals
Posted 10/13/2021
Novartis Pharmaceuticals
Posted 11/22/2018
Novartis Pharmaceuticals
Posted 4/24/2014
Novartis Pharmaceuticals
Posted 12/6/2021
Strand Therapeutics Doses First Patient with Programmable mRNA Cancer Therapy STX-001 in Phase 1 Trial
- Strand Therapeutics has dosed the first patient with STX-001, marking the entry of the first programmable mRNA therapy in oncology into clinical trials for solid tumors.
- STX-001 uses self-replicating mRNA technology to express IL-12 cytokine directly within the tumor microenvironment for extended duration.
- The Phase 1 trial will evaluate STX-001 as monotherapy and in combination with pembrolizumab in patients with treatment-refractory advanced solid tumors.
- Preclinical studies showed STX-001 induced immunogenic cancer cell death and promoted recruitment and activation of T cells and NK cells in the tumor microenvironment.
BlueRock Therapeutics' Bemdaneprocel Receives FDA RMAT Designation for Parkinson's Disease
- BlueRock Therapeutics' bemdaneprocel, a cell therapy for Parkinson's disease, has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
- The RMAT designation allows for expedited development review and planning guidance from the FDA, potentially accelerating the path to approval.
- Phase I trial data showed bemdaneprocel was well-tolerated with no major safety issues after 18 months, and demonstrated cell survival in the brain.
- Bemdaneprocel aims to replace dopamine-producing neurons lost in Parkinson's, offering a potential disease-modifying treatment option.
Highlighted Clinical Trials:
BlueRock Therapeutics
Posted 5/3/2021
Breakthroughs and Trends in Anti-Obesity Drug Development for 2024
The anti-obesity drug landscape is evolving with the introduction of breakthrough treatments like Semaglutide and Tirzepatide, alongside the development of innovative monotherapies, combination therapies, and emerging injectable pharmacotherapies. The focus is also shifting towards oral drug formulations and addressing sarcopenia in obesity treatment. Preclinical research and clinical trials continue to play a crucial role in advancing obesity therapeutics.
Astellas Resubmits Zolbetuximab BLA for CLDN18.2-Positive Gastric Cancer
- Astellas has resubmitted its Biologics License Application (BLA) to the FDA for zolbetuximab for treating CLDN18.2-positive gastric or GEJ adenocarcinoma.
- The FDA has set a new target action date of November 9, 2024, under the Prescription Drug User Fee Act (PDUFA) for zolbetuximab.
- The BLA is based on Phase 3 SPOTLIGHT and GLOW trial results, evaluating zolbetuximab plus chemotherapy versus placebo plus chemotherapy.
- Zolbetuximab, a first-in-class CLDN18.2-targeted monoclonal antibody, has already been approved in Japan for gastric cancer treatment.
Highlighted Clinical Trials:
Astellas Pharma Global Development, Inc.
Posted 11/28/2018
Astellas Pharma Global Development, Inc.
Posted 6/7/2022
Astellas Pharma Global Development, Inc.
Posted 3/15/2019
Astellas Pharma Global Development, Inc.
Posted 6/21/2018
Passage Bio Advances in Clinical Trial for Genetic FTD Treatment
Passage Bio reports promising progress in its phase 1/2 clinical trial for a genetic form of FTD, with updated interim data showing elevated progranulin levels in patients. The company plans to dose a second cohort in 2024 and expects further data by 2025.
Cellectar Biosciences Partners with City of Hope Cancer Center for Iopofosine Clinical Development
Cellectar Biosciences, Inc. has entered a strategic partnership with City of Hope Cancer Center to advance the clinical development of iopofosine I 131, targeting mycosis fungoides, a rare form of non-Hodgkin’s lymphoma. This collaboration aims to explore new treatment paradigms for patients with limited curative options.
FDA Accepts Milestone's Cardamyst NDA for PSVT Treatment
- The FDA has accepted Milestone Pharmaceuticals' NDA for Cardamyst (etripamil) nasal spray, a potential treatment for paroxysmal supraventricular tachycardia (PSVT).
- Cardamyst is designed for patient self-administration, offering a rapid-response therapy to manage PSVT episodes without immediate medical oversight.
- The PDUFA target date for the FDA's decision on Cardamyst is set for 10 months from the NDA acceptance date of May 26, 2024.
- PSVT affects an estimated two million people in the U.S., and Cardamyst aims to provide a convenient and effective treatment option.
Inavolisib Receives FDA Priority Review for PIK3CA-Mutated Breast Cancer
- The FDA granted Priority Review to inavolisib in combination with palbociclib and fulvestrant for advanced HR-positive, HER2-negative breast cancer with PIK3CA mutation.
- Phase III INAVO120 trial data showed the inavolisib regimen more than doubled progression-free survival compared to palbociclib and fulvestrant alone.
- Inavolisib is an investigational oral therapy designed to minimize treatment burden with high potency and specificity for the PI3K alpha isoform.
- The FDA's decision is based on the potential for significant improvement in treating this specific type of breast cancer, with a PDUFA date of November 27, 2024.
Highlighted Clinical Trials:
Hoffmann-La Roche
Posted 6/7/2023
Hoffmann-La Roche
Posted 1/29/2020