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307 news found

AngioDynamics Announces CE Mark Approval in Europe for AlphaVac F1885 System

AngioDynamics Announces CE Mark Approval in Europe for AlphaVac F1885 System

“This designation allows us to broaden our reach and provide innovative solutions to more healthcare professionals treating patients diagnosed with PE – on an increasingly global scale.” An estimated 435,000 PE events occur each year in the six largest European Union (EU) countries.1 Compared to the United States, the prevalence of PE is higher for those ...

ByAngioDynamics, Inc.


AngioDynamics Completes Patient Enrollment in APEX-AV Study Assessing AlphaVac F1885 System in Treatment of Pulmonary Embolism

AngioDynamics Completes Patient Enrollment in APEX-AV Study Assessing AlphaVac F1885 System in Treatment of Pulmonary Embolism

(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 ...

ByAngioDynamics, Inc.


Stemline Therapeutics, a subsidiary of Menarini Group, Receives U.S. FDA Approval for ORSERDU (elacestrant) as the First and Only Treatment Specifically Indicated for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer

Stemline Therapeutics, a subsidiary of Menarini Group, Receives U.S. FDA Approval for ORSERDU (elacestrant) as the First and Only Treatment Specifically Indicated for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer

For more information, patients and healthcare professionals can call 1-833-4-STEMLINE (1-833-478-3654). ...

ByThe Menarini Group


MorphoSys Presents Preliminary Results from Phase 1/2 Study of Tulmimetostat (CPI-0209) Supporting Its Potential Application in a Broad Array of Advanced Tumors

MorphoSys Presents Preliminary Results from Phase 1/2 Study of Tulmimetostat (CPI-0209) Supporting Its Potential Application in a Broad Array of Advanced Tumors

” At data cutoff (July 16, 2022), 51 of 52 patients enrolled in the Phase 2 expansion phase of the trial had received at least one dose of tulmimetostat in the following cohorts: metastatic castration-resistant prostate cancer, lymphoma, BAP1-mutated mesothelioma, ARID1A-mutated ovarian clear cell carcinoma, ARID1A-mutated endometrial carcinoma and ...

ByMorphoSys AG


Iterative Scopes Partners with One GI to Advance Gastrointestinal Care Through Artificial Intelligence

Iterative Scopes Partners with One GI to Advance Gastrointestinal Care Through Artificial Intelligence

The implementation of AIR will aid in the recruitment of patients for clinical trials focused on inflammatory bowel disease (IBD). ...

ByIterative Health, Inc.


Antengene Enters into a Global Clinical Collaboration with MSD to Evaluate ATG-037 (CD73 Inhibitor) in Combination with KEYTRUDA (pembrolizumab)

Antengene Enters into a Global Clinical Collaboration with MSD to Evaluate ATG-037 (CD73 Inhibitor) in Combination with KEYTRUDA (pembrolizumab)

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 ...

ByAntengene Corporation Limited


Carrick Therapeutics and The Menarini Group Announce Clinical Trial Collaboration to Evaluate Samuraciclib and Elacestrant Combination

Carrick Therapeutics and The Menarini Group Announce Clinical Trial Collaboration to Evaluate Samuraciclib and Elacestrant Combination

The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+, HER2- advanced/metastatic breast cancer patients. The study enrolled 478 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK 4/6 inhibitor. ...

ByThe Menarini Group


Galapagos and CellPoint presented encouraging initial data at ASH 2022 for GLPG5101, a CD19 CAR-T candidate manufactured at point-of-care

Galapagos and CellPoint presented encouraging initial data at ASH 2022 for GLPG5101, a CD19 CAR-T candidate manufactured at point-of-care

The dose levels that are evaluated in the Phase 1 part of the study are 50x106 (DL1), 110x106 (DL2) and 250x106 (DL3). As of 8 November 2022, 9 patients were enrolled; baseline and safety data for 8 patients were available (n=4 at DL1; n=4 at DL2). 7 patients reached the follow-up period of 28-days and were eligible for efficacy ...

ByGalapagos NV


Menarini Group Presents Updated Results from Pivotal Phase 3 EMERALD Trial at the 2022 San Antonio Breast Cancer Symposium (SABCS) that Demonstrate Elacestrant’s PFS Increases with Duration of Prior CDK4/6i in ER+, HER2- in Metastatic Setting

Menarini Group Presents Updated Results from Pivotal Phase 3 EMERALD Trial at the 2022 San Antonio Breast Cancer Symposium (SABCS) that Demonstrate Elacestrant’s PFS Increases with Duration of Prior CDK4/6i in ER+, HER2- in Metastatic Setting

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 ...

ByThe Menarini Group


Pulmonx Receives Japanese MHLW Approval of Zephyr Endobronchial Valve for the Treatment of Severe COPD/Emphysema

Pulmonx Receives Japanese MHLW Approval of Zephyr Endobronchial Valve for the Treatment of Severe COPD/Emphysema

Until now, the only other options for these patients were invasive treatments such as lung volume reduction surgery or lung transplantation. ...

ByPulmonx Corporation


BioXcel Therapeutics Announces First Patients Dosed in SERENITY III Phase 3 Trial for Acute Treatment of Agitation in Adults with Bipolar I or II Disorder or Schizophrenia

BioXcel Therapeutics Announces First Patients Dosed in SERENITY III Phase 3 Trial for Acute Treatment of Agitation in Adults with Bipolar I or II Disorder or Schizophrenia

The first part of the study is similar to SERENITY I and II and designed to assess the efficacy and safety of a 60mcg dose in acutely agitated patients with bipolar disorder or schizophrenia in a monitored setting. The primary efficacy endpoint is the change from baseline in Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at two hours after dosing ...

ByBioXcel Therapeutics, Inc.


BRIM Biotech submits US Phase 3 clinical trial protocol for BRM421 in the treatment of dry eye disease to the FDA

BRIM Biotech submits US Phase 3 clinical trial protocol for BRM421 in the treatment of dry eye disease to the FDA

The Phase 3 clinical trial will be a multi-center, double-blind, randomized, placebo-controlled trial in the United States. BRIM plans to enroll more than 700 patients with moderate to severe DED. The clinical trial is expected to be completed in the fourth quarter of 2023, depending on the status of patient enrollment. ...

ByBRIM Biotechnology, Inc.


Onconova Therapeutics Announces Plans For A Phase 1/2a Trial Of Narazaciclib Combined With Letrozole In Endometrial Cancer, Reports Third Quarter 2022 Financial Results, And Provides A Business Update

Onconova Therapeutics Announces Plans For A Phase 1/2a Trial Of Narazaciclib Combined With Letrozole In Endometrial Cancer, Reports Third Quarter 2022 Financial Results, And Provides A Business Update

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, ...

ByTraws Pharma


IN8bio Reports Third Quarter 2022 Financial Results and Highlights Recent Company Progress

IN8bio Reports Third Quarter 2022 Financial Results and Highlights Recent Company Progress

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. ...

ByIN8Bio Inc.


Peter MacCallum Cancer Centre and Cartherics Announce Collaboration to Develop Autologous CAR-T Cell Therapy for Cutaneous T-Cell Lymphoma

Peter MacCallum Cancer Centre and Cartherics Announce Collaboration to Develop Autologous CAR-T Cell Therapy for Cutaneous T-Cell Lymphoma

” The key aspects of the collaborative research are setting up clinical-scale manufacturing of CTH-001 and conducting a Phase I clinical trial. This will initially enrol six patients with refractory CTCL. The primary goal of the clinical trial is to investigate the safety of CTH-001 in this patient population. ...

ByCartherics Pty ltd


Galapagos to present encouraging initial data from FILOSOPHY real-world arthritis study at ACR Convergence 2022

Galapagos to present encouraging initial data from FILOSOPHY real-world arthritis study at ACR Convergence 2022

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 provider community, in particular initial data from our first international, real-world arthritis study. We believe that it’s not only important to control disease activity to prevent long term ...

ByGalapagos NV


IN8bio to Present Positive Early Data from Ongoing Phase 1 Study of INB-100 at the 64th American Society of Hematology Annual Meeting

IN8bio to Present Positive Early Data from Ongoing Phase 1 Study of INB-100 at the 64th American Society of Hematology Annual Meeting

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 ...

ByIN8Bio Inc.


Antengene Receives U.S. FDA Clearance of IND Application for Phase I Trial of Small Molecule ERK1/2 Inhibitor ATG-017 in Patients with Advanced Solid Tumors

Antengene Receives U.S. FDA Clearance of IND Application for Phase I Trial of Small Molecule ERK1/2 Inhibitor ATG-017 in Patients with Advanced Solid Tumors

“Every day, we see advanced cancer patients with limited treatment options. We intend to initiate the study in the U.S. soon, and hope that ATG-017 will eventually offer a safe and effective new treatment option to those patients in need.” “The development of new therapies for cancer patients with refractory, relapsed, or ...

ByAntengene Corporation Limited


Evolution of ePROM: Advancements, Concerns, and the Way Forward

Evolution of ePROM: Advancements, Concerns, and the Way Forward

This is paving the way for improving patient care as ePROMs can be used to monitor patients with reported health conditions coming directly from the patient, so caregivers and clinicians can know about the patient’s health concerns outside the clinical setting. ...

ByJeeva Informatics Solutions Inc.


Inari Medical Announces In-hospital and 30-day Outcomes from the Fully Enrolled CLOUT Registry and Results from Propensity-Score Matched Comparison of CLOUT vs. ATTRACT

Inari Medical Announces In-hospital and 30-day Outcomes from the Fully Enrolled CLOUT Registry and Results from Propensity-Score Matched Comparison of CLOUT vs. ATTRACT

(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 ...

ByInari Medical

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