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AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced European CE Mark approval of the AlphaVac F1885 System for the non-surgical removal of thrombi or emboli from the pulmonary arteries and for ...
AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced the completion of patient enrollment in the Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV). APEX-AV is a ...
ESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers. ESR1 mutations are a known driver of resistance to standard endocrine therapy, and so far, have been difficult to treat. ORSERDU is the first endocrine innovation in more than 20 years, specifically addressing ESR1 mutations, a major unmet need. The Menarini Group (“Menarini”), a ...
MorphoSys AG (FSE: MOR; NASDAQ: MOR) today announced that preliminary results from the ongoing Phase 1/2 study (NCT04104776) of tulmimetostat (CPI-0209) monotherapy in heavily pretreated patients with advanced cancers showed responses or disease stabilization in five cohorts with evaluable patients. Tulmimetostat is an oral, investigational next-generation selective dual inhibitor of EZH2 and ...
Iterative Scopes, a pioneer in precision-medicine technologies for gastroenterology, announced today that it has partnered with One GI®, a gastroenterology management services organization (MSO), to bring its AI Recruitment (AIR) technology to One GI’s clinical research. Initially, One GI® will use AIR at Gastro One, one of One GI’s clinical research sites in Memphis, ...
ATG-037 is Antengene’s oral small molecule CD73 inhibitor; KEYTRUDA® (pembrolizumab) is MSD’s anti-PD-1 therapy The clinical trial collaboration will focus on evaluating ATG-037 as a monotherapy and in combination with KEYTRUDA® for the treatment of locally advanced or metastatic solid tumors The study of ATG-037 monotherapy started enrolling patients in Q2 2022 and will ...
Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced a clinical trial collaboration and supply agreement. This agreement covers the execution of a Phase 2 clinical trial to evaluate the novel combination of ...
Galapagos NV (Euronext & NASDAQ: GLPG) and CellPoint (a Galapagos company) today presented encouraging initial data from the ongoing ATALANTA-1 Phase 1/2 study with GLPG5101 at the 64th Annual American Society of Hematology (ASH) Congress taking place in New Orleans, Louisiana, from 10-13 December. ATALANTA-1 is a Phase 1/2 study in heavily pre-treated rrNHL patients to evaluate the safety, ...
Elacestrant demonstrated longer progression-free survival (PFS) vs SOC endocrine therapy with medians up to 8.6 months, positively associated with the duration of prior treatment with CDK4/6 inhibitors Elacestrant side effects were manageable and consistent with previously reported results Results demonstrate that elacestrant may have the potential to become a new standard of care as a ...
Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx”), a global leader in minimally invasive treatments for severe lung disease, announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the Zephyr® Endobronchial Valve for treating severe COPD/emphysema patients following a positive recommendation by Pharmaceuticals and Medical Devices Agency (PMDA). ...
SERENITY III will evaluate the efficacy and safety of BXCL501 for at-home use Top-line pivotal data expected in 1H 2023 Estimated 23 million annual agitation episodes in the home-setting would more than double current market opportunity for BXCL501 in the U.S. 1-4 BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop ...
BRIM Biotechnology, Inc. (“BRIM,” TPEx 6885) announced today that it has officially submitted the Phase 3 clinical trial protocol for BRM421 in the treatment of dry eye disease (DED) to the U.S. Food and Drug Administration (FDA). If the FDA has no further comments after the 30-day review period, BRIM will proceed to initiate the Phase 3 clinical trial in December. Based on its ...
Both narazaciclib and letrozole will be administered orally with a continuous daily dosing schedule in the trial, which will begin with a Phase 1 dose escalation phase before moving to a Phase 2 expansion cohort designed to enroll approximately 30 patients. The primary objective of the Phase 1 portion of the trial will be to evaluate safety, tolerability, ...
INB-100 continued to demonstrate durable morphologic complete responses in the Phase 1 clinical trial in patients with leukemia; on track to announce additional data at upcoming ASH annual meeting. Partnered with the Dunbar CAR T-Cell Program at the University of Louisville as the GMP manufacturing center for INB-400. Strengthened the balance sheet through an equity offering raising net ...
The Peter MacCallum Cancer Centre (“Peter Mac”) and Cartherics Pty Ltd (“Cartherics”) announced today they have entered into a Collaborative Development Program Agreement (CDPA) to develop Cartherics’ proprietary autologous CAR-T cell therapy (CTH-001) for the treatment of cutaneous T-cell lymphoma (CTCL). “Patients with advanced stages of cutaneous T-cell ...
Galapagos NV (Euronext & NASDAQ: GLPG) will present new data on filgotinib at the American College of Rheumatology (ACR) Convergence 2022 meeting taking place in Philadelphia, Pennsylvania from 10-14 November 2022. Dr. Walid Abi-Saab, Chief Medical officer, at Galapagos said, “We are excited to present data at ACR which highlights our continued commitment to patients and the healthcare ...
Data support the potential of INB-100 to induce long-term durable responses in patients with high-risk or relapsed acute myeloid leukemia (AML). Clinical activity observed includes continuing robust durability of relapse-free survival; all three patients in Cohort 1 remain alive and progression-free; ongoing durations of response exceed 12 months and extend beyond 25 months. To date, INB-100 ...
ATG-017 is a small molecule ERK1/2 inhibitor and Antengene has obtained exclusive global rights to develop, commercialize and manufacture ATG-017. IND clearance enables Antengene to initiate the combination portion of the Phase I “ERASER” clinical trial in the United States (U.S.) to evaluate the safety, pharmacokinetics, and preliminary efficacy of ATG-017 combination therapy ...
Patients’ directly reported outcomes in certain rare and chronic diseases are considered reliable for understanding the disease’s natural history, palliative treatments that focus primarily on symptom control, and quality of life. Electronic Patient-Reported Outcome Measures (ePROMs) are now allowing these patients to self-report health conditions and treatment effectiveness ...
Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous and other diseases, announced positive in-hospital and 30-day outcomes from the fully-enrolled 500-patient CLOUT registry. The company also reported positive results from a propensity-matched comparison of patients ...