MedPath

Acumen Pharmaceuticals Advances Sabirnetug in Alzheimer's Disease Treatment

9/29/2024

Acumen Pharmaceuticals is developing sabirnetug (ACU193), a monoclonal antibody targeting toxic amyloid-beta oligomers, a primary cause of Alzheimer's disease.

858 Therapeutics Secures $50 Million in Series B Funding to Advance PARG Inhibitor ETX-19477

9/29/2024

858 Therapeutics raised $50 million in Series B funding, led by Avidity Partners, to advance its pipeline of small-molecule therapeutics.

FINE-REAL Study Shows Finerenone Use in Real-World Settings Aligns with Clinical Trial Data for CKD and T2D

9/29/2024

Interim results from the FINE-REAL study indicate that finerenone is being initiated in routine clinical practice across various settings for patients with CKD and T2D.

Short-Term ADT Plus High-Dose Radiotherapy Improves Outcomes in Localized Prostate Cancer

9/29/2024

A phase 3 trial (GETUG 14) reveals that combining short-term androgen deprivation therapy (ADT) with high-dose radiotherapy improves disease-free survival in localized prostate cancer patients.

Alzheimer's Drug Lecanemab Faces Scrutiny as Swissmedic Weighs Approval

9/30/2024

Swissmedic is expected to decide by the end of 2024 whether to approve lecanemab, the first new Alzheimer’s drug in two decades.

CaaMTech Receives Regulatory Validation for Functional Unblinding Strategy in Psilocin Prodrug Trial

11/15/2024

CaaMTech received positive feedback from U.S. regulators for its CT-4201 psilocin prodrug program, which includes a strategy for functional unblinding in clinical trials.

CNSide CSF Assay Shows Promise in Leptomeningeal Metastases Diagnosis

11/22/2024

The FORESEE trial demonstrated that the CNSide CSF Assay influenced clinical management decisions in over 90% of leptomeningeal metastases (LM) cases, exceeding the target endpoint.

FDA Approves New Nilotinib Formulation (Danziten) for Chronic Myeloid Leukemia Without Mealtime Restrictions

11/15/2024

The FDA has approved Danziten (nilotinib), a new formulation of nilotinib, for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

Samsung Bioepis Receives Positive EMA Opinion for Denosumab Biosimilars Obodence and Xbryk

11/18/2024

Samsung Bioepis received a positive CHMP opinion for Obodence and Xbryk, biosimilars of Amgen's Prolia and Xgeva, respectively, targeting osteoporosis and skeletal-related conditions.

BrightHeart's AI-Powered Prenatal Ultrasound Software Receives FDA Clearance

11/18/2024

BrightHeart's AI software has received FDA 510(k) clearance for prenatal ultrasound evaluations of the fetal heart, aiding in the detection of congenital heart defects (CHDs).

Tofersen Closer to Approval for SOD1-Related MND After NICE Reconsideration

11/19/2024

NICE has reconsidered its decision for Tofersen, a drug that slows the progression of Motor Neurone Disease (MND) in individuals with the SOD1 genetic change.

JNJ-2113 Shows Promising Phase 3 Results for Plaque Psoriasis

11/19/2024

Phase 3 trials ICONIC-LEAD and ICONIC-TOTAL showed JNJ-2113 significantly improved skin clearance in moderate to severe plaque psoriasis patients.

Praxis Precision Medicines Advances CNS Pipeline with Key Clinical Trial Milestones

11/20/2024

Praxis Precision Medicines' PRAX-114 Phase 2/3 clinical trial for Major Depressive Disorder (MDD) is set to begin in March 2021 after IND clearance.

FDA Clears Medtronic's InPen App for Smart MDI System with Simplera CGM

11/20/2024

Medtronic receives FDA clearance for its updated InPen app, designed for use with the Simplera CGM system, enhancing its smart multiple daily injection (MDI) system.

Merck's Winrevair Shows Promise in Pulmonary Hypertension, While Biohaven and Cassava Face Setbacks

11/25/2024

Merck's Winrevair significantly reduced the risk of death in patients with pulmonary arterial hypertension, marking a potential breakthrough in treating this rare lung condition.

FDA Grants Accelerated Approval to Zanidatamab for HER2-Positive Biliary Tract Cancer

11/21/2024

The FDA has granted accelerated approval to zanidatamab-hrii (Ziihera) for previously treated, unresectable or metastatic HER2-positive biliary tract cancer.

Science 37 and GSK Enhance Rare Disease Trial Enrollment with Decentralized Approach

11/21/2024

Science 37 significantly boosted U.S. enrollment in GSK's Phase 3 trial for primary biliary cholangitis (PBC) by utilizing a direct-to-participant model.

Kisunla (lecanemab) Offers New Hope for Alzheimer's Patients, Slowing Cognitive Decline

11/22/2024

Kisunla (lecanemab), an FDA-approved drug, offers hope by targeting and breaking down amyloid plaques in the brain, which are associated with Alzheimer's disease.

Ultromics' AI Software for Cardiac Amyloidosis Receives FDA Approval

11/22/2024

Ultromics' artificial intelligence (AI) software has secured FDA approval for the diagnosis of cardiac amyloidosis, offering a new tool for identifying the disease.

Hemophilia B Therapeutics: Advances in Clinical Trials and Emerging Therapies

11/28/2024

Several companies are actively involved in developing therapies for Hemophilia B, with Belief Biomed's drug candidates reaching Phase III clinical trials.

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