Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

FDA Grants Breakthrough Device Status to TOBY’s Urine Test for Alzheimer’s Detection; ubtle Medical Achieves FDA Clearance for Next-Gen SubtleHD™(PET) Software; Ernest Health Expands Rehabilitation Network Through Reunion Hospitals Deal; Olympus Expands Prostate Cancer Footprint Through BioProtect Acquisition; ABILITY Neurotech Secures IMDD Approval for Clinical Trial of Chronic Brain-Computer Interface Implantation in ALS Patients; Implantica Reports Strong Economic Benefits of RefluxStop® in Italian GERD Treatment Study

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QT Imaging Secures FDA Clearance for Enhanced Breast Acoustic CT Scanner Configuration; LifeVac Secures FDA Authorization as the First and Only Anti-Choking Device; Smith+Nephew Introduces Next-Generation ALLEVYN COMPLETE CARE Foam Dressing for Enhanced Wound Management; Olympus Corporation Debuts Next-Gen Surgical Visualization Platform in the U.S.; IceCure Medical Receives FDA Approval for Post-Marketing ‘CHOICE’ Study of ProSense Cryoablation System; Envoy Medical Concludes Enrollment for Landmark Trial of Fully Implanted Cochlear Implant

pharma-news-assessment-for-roche-ipsen-bms

Roche Reveals Update from Phase III persevERA Study Targeting ER-Positive Advanced Breast Cancer; Ipsen Confirms Voluntary Withdrawal of TAZVERIK for Select Oncology Indications; Bristol Myers Squibb Unveils Positive Phase 3 Data from SUCCESSOR-2 Study Evaluating Mezigdomide in R/R Multiple Myeloma; Servier Announces Acquisition of Day One Biopharmaceuticals to Bolster Rare Cancer Portfolio; Pfizer Advances Trispecific Antibody with Positive Phase 2 Results in Atopic Dermatitis

medtech-news-for-abbott-mobia-medical-baird-medical

Abbott’s New CardioMEMS™ Remote Monitoring Reader Gains FDA Approval; Mobia Medical and Sanford Health Secure FDA Approval for Vivistim Stroke Therapy; Johnson & Johnson Introduces Cereglide™ 42, Cereglide™ 57, and Innerglide™ 7 to Strengthen Catheter Portfolio; Baird Medical Advances Worldwide Registration of AI-Based Surgical Technology; THINK Surgical Achieves First Clinical Use of the TMINI Miniature Robotic System Paired With the Stryker Triathlon Knee System; Monteris Medical Reports Study Linking NeuroBlate® Laser Ablation to Stronger Immunotherapy Response in Recurrent High-Grade Brain Tumors

pharma-news-for-merck-roche-novartis

Merck’s WELIREG Advances with FDA Priority Review in Early RCC Supported by Compelling DFS Evidence; Roche’s Fenebrutinib Delivers Another Phase III Victory; Positive CHMP Opinion Paves Way for Novartis’ Remibrutinib in CSU Treatment; Pfizer’s BRAFTOVI Regimen Gains FDA’s Full Nod for Initial Treatment of Metastatic Colorectal Cancer; VYVGART Achieves Positive Results in Phase 3 ADAPT OCULUS Trial

medtech-news-for-galderma-4web-medical-medtronic

Galderma Secures Triple Approval for Its New Cutting-Edge Restylane® Syringe Across the European Union, United States, and Canada; 4WEB Medical Secures FDA 510(k) Clearance for New SI Joint Truss System; Medtronic Debuts MiniMed Go Smart Insulin-Delivery System Featuring Simplera Sensor in the EMEA Region; Olympus Expands Labeling to Include Pediatric Use for Two Single-Use Bronchoscopes; Neurent Medical Reports Positive Randomized Controlled Trial Outcomes for the NEUROMARK® System; Envoy Medical Approaches Final Enrollment Phase for Its Fully Implanted Acclaim Cochlear Implant Trial

pharma-news-for-gilead-novo-vanda

Gilead Sciences to Acquire Arcellx in Strategic Move to Accelerate Anito-cel Development; Novo Nordisk Faces Setback as CagriSema Underwhelms Against Rival Therapy in Trial; Vanda Pharmaceuticals Secures FDA Approval for BYSANTI; All-oral Calquence + venetoclax Combo Clears in the US for First-line Treatment of CLL; Merck’s ENFLONSIA Demonstrates Strong Protection Against Severe RSV in Young Children Over Consecutive Seasons

medtech-news-for-medtronic-retia-medical-danaher

Medtronic Wins FDA Green Light for Stealth AXiS; Retia Medical Secures FDA 510(k) Clearance for Argos Infinity; Danaher Announces Plan to Acquire Masimo Corporation; Dynarex Introduces New Advanced Negative Pressure Therapy Device; Valcare Medical Reports First U.S. Transseptal AMEND™ Implant in Early Feasibility Study; Envoy Medical Reports Enrollment Nearly Complete for Acclaim Cochlear Implant Pivotal Trial

pharma-news-for-roche-novartis-ptc

Roche’s GAZYVA/GAZYVARO Achieves Key Phase III Success in Primary Membranous Nephropathy; Novartis’ VANRAFIA Slows Kidney Function Decline in Phase III IgA Nephropathy Trial; PTC Therapeutics Shares Latest Regulatory Developments for Translarna; BridgeBio’s Oral Infigratinib Achieves Key Body Proportionality Improvements in Phase 3 Achondroplasia Trial; Upstream Bio’s Verekitug Achieves Key Endpoints in Phase 2 Trial for Severe Asthma Treatment

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Hologic Gains FDA Clearance for Aptima® HPV Assay as Primary Screening Tool; ZOLL Zenix Monitor/Defibrillator Achieves MDR Approval; Labcorp Unveils FDA-Cleared Blood Test for Alzheimer’s Screening; P&F SecureD EU MDR CE Mark Approval for the TricValve® System; Valcare Medical Performs First U.S. Transseptal AMEND™ Implant as Part of Early Feasibility Study; Hyperfine Unveils New Clinical Results Showing Improved Stroke Detection with the Swoop® System

pharma-news-for-sanofi-lilly-roche

Sanofi Advances wAIHA Program as Rilzabrutinib Receives Breakthrough and Orphan Status; Lilly Moves to Acquire Orna Therapeutics, Expanding Cell Therapy Portfolio; Roche Announces Key PPMS Trial Success for Fenebrutinib; Priovant’s Brepocitinib Demonstrates Strong Potential in Phase 2 Cutaneous Sarcoidosis Study; AstraZeneca’s DATROWAY Grants US Priority Review for 1L mTNBC Indication in Patients not Eligible for Immunotherapy

medtech-news-for-ge-healthcare-oracale-life-sciences-revbio

GE HealthCare Secures FDA 510(k) Clearance and CE Mark for Allia Moveo, Completing First Global Installation; China NMPA Approves Promega’s MSI Test as a Companion Diagnostic for KEYTRUDA; Oracle Life Sciences AI Data Platform Unifies Data and Agentic Intelligence to Accelerate Breakthroughs and Boost Commercial Outcomes; Quest Diagnostics Launches New Blood Test for Detecting Minimal Residual Myeloma; RevBio Secures FDA Clearance to Begin Pivotal Study of Cranial Bone Glue; Hyperfine Reports Breakthrough Clinical Findings on Swoop® System’s Increased Sensitivity in Stroke Detection

pharma-news-for-novo-nordisk-sanofi-kyowa-kirin

Novo Nordisk A/S Announces that CagriSema Delivered Superior Outcomes in REIMAGINE 2; Sanofi’s Venglustat Clears all Primary Hurdles in Phase 3 Gaucher Disease Trial; Kyowa Kirin Reacquires Full Development and Commercialization Rights for Rocatinlimab; IMFINZI Receives CHMP Recommendation for Perioperative Treatment in Patients with Resectable Gastric and Gastroesophageal Cancers; Tenpoint Wins FDA Approval for First-Ever Combination Presbyopia Eye Drop

medtech-news-for-seno-medical-spine-innovation-laborie

Seno Medical Secures EU MDR CE Mark for Next-Generation Imagio® Imaging System; Spine Innovation Announces FDA 510(k) Clearance of LOGIC™ Titanium Expandable Interbody System; Laborie Adds JADA® System to Obstetrics Portfolio for Rapid PPH Control; Olympus Introduces SecureFlex™ Single-Use Fine Needle Biopsy Device in the U.S.; Kardium Publishes PULSAR Pivotal Trial Findings in JACC; Myra Vision Begins U.S. ADAPT Glaucoma Study, Treating First Participant

pharma-news-for-sanofi-corcept-corxel

Sanofi Strengthens Amlitelimab’s Position in Atopic Dermatitis; Corcept Announces Statistically Significant Overall Survival Benefit in Phase 3 ROSELLA Study; CORXEL Raises $287M Series D1 for Cardiometabolic Pipeline Expansion; IntraBio’s Levacetylleucine Demonstrates Positive Results in Pivotal Ataxia-Telangiectasia Trial; Otsuka Secures FDA Acceptance and Priority Review for Centanafadine in ADHD

medtech-news-for-sonomotion-aidoc-bd

Sonomotion Secures FDA Clearance for Break Wave™ Lithotripsy System; Aidoc Earns FDA Clearance for Comprehensive AI Foundation Model in Healthcare; BD and Ypsomed Deepen Partnership to Serve Expanding Biologics Market; Omnia Medical Launches FDA-Approved PsiF DNA™ System to Market; Kardium Publishes PULSAR Pivotal Trial Findings in JACC; NEURO PMR Data Validates Hyperfine’s Diagnostic Precision and Patient-Centered Care

pharma-news-for-nxera-astrazeneca-abbvie

Nxera Pharma Confirms Positive Phase 3 Findings for Daridorexant in South Korea; AstraZeneca Strengthens Oncology Pipeline in China With GPC3 Armored CAR-T Rights From AbelZeta; AbbVie Shares Topline Findings from Phase 3 EPCORE DLBCL-1 Study of Epcoritamab; ImmunityBio Achieves Prolonged Complete Response Using Chemotherapy-Free CD19 CAR-NK Platform; Sobi Wins EU Approval for ASPAVELI to Treat C3G and Primary IC-MPGN

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