Clinical Trial News
Neutrophil exhaustion and impaired functionality in psoriatic arthritis patients - Frontiers
Study evaluates PMNs and NETs in PsA patients, finding distinct phenotypic and functional deficits compared to HCs, including lower expression of activation markers, reduced ROS production, diminished phagocytosis, and less granular enzyme and NET biomarker release. Elevated serum levels of neutrophil-related mediators and NET biomarkers in PsA patients suggest a distinct neutrophil signature associated with PsA.
Strides Pharma hits all time high after USFDA approval for this drug | News on Markets
Strides Pharma share price hit an all-time high after its Singapore subsidiary received USFDA approval for generic Theophylline extended-release tablets, to be manufactured in Bangalore.
FDA Drug Approval Decisions Expected in October 2024 - MPR - eMPR.com
Dasiglucagon for congenital hyperinsulinism has a PDUFA date of October 8, 2024, supported by phase 3 trials. Perioperative nivolumab-based regimen for resectable NSCLC also has a PDUFA date of October 8, 2024, based on the CheckMate -77T trial. Oclaiz (CAM2029) for acromegaly has a PDUFA date of October 21, 2024, supported by phase 3 studies. Sulopenem etzadroxil/probenecid for uncomplicated UTI has a PDUFA date of October 25, 2024, with data from the REASSURE trial.
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IN8bio cuts staff and pipeline to focus on AML cell therapy - Clinical Trials Arena
IN8bio reduces headcount by 49% and suspends glioblastoma programme to focus on AML cell therapy INB-100, aiming for a registrational trial. The board and management team also cut cash compensation by 11%. IN8bio plans to add a control cohort to its ongoing Phase I trial and expand the Phase II dose cohort, with enrolment expected by H1 2025.
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Sun Pharma and Israel-based Moebius Medical announce USFDA grant of Fast Track ...
Sun Pharmaceutical Industries and Moebius Medical received FDA Fast Track designation for MM-II (Large Liposomes of DPPC and DMPC) to treat osteoarthritis knee pain, with Phase 3 clinical trials planned.
GSK Asthma Drug Shows Promise in Treating Chronic Lung Disease - BNN Bloomberg
GSK's Nucala showed significant reduction in COPD flare-ups in a trial, potentially expanding its use beyond asthma treatment.
Lykos CEO to depart after FDA rejection, layoffs | BioPharma Dive
Lykos Therapeutics CEO Amy Emerson to step down after FDA rejection of MDMA therapy aid approval. Michael Mullette appointed interim CEO. Company plans to cut 75% of workforce and resubmit MDMA approval application.
Sept. 5, 2024: Clinical trials hope to curb and reverse Alzheimer's; EVs drive a shift for firefighters
Clinical trial in Colorado aims to treat Alzheimer's; electric vehicles impact firefighting; Native American skier Ross Anderson inducted into Colorado Snowsports Museum; Mount Blue Sky closes for repairs until 2026; 'Turn the Page with Colorado Matters' features Tim Winegard's 'The Horse.'
First Patient Enrolled in Phase 1b/2 Triplet Therapy Trial of REZLIDHIA in mIDH1 AML
Rigel Pharmaceuticals announced the first patient enrolled in a Phase 1b/2 triplet therapy trial of REZLIDHIA (olutasidenib) combined with decitabine and venetoclax for mIDH1 AML, conducted by MD Anderson. The trial aims to determine safety, tolerability, and complete remission rates in newly diagnosed and relapsed/refractory patients.
Verastem's Path To FDA Approval: High-Risk, High-Reward Oncology Opportunity
Verastem, Inc. (VSTM) develops cancer treatments targeting the RAS/MAPK pathway, focusing on pancreatic, lung, colorectal, and low-grade serous ovarian cancers. Its leading therapy combines Avutometinib and Defactinib, with a rolling NDA submission expected to finalize by 2H2024 for recurrent LGSOC. VSTM also explores additional indications for metastatic pancreatic cancer and mKRAS G12C NSCLC. The company's tight cash runway makes it a high-risk, high-reward investment, but its current valuation and pathway to approval suggest a bullish outlook.