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Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Alcon’s 510(k) Clearance From the FDA; Globus Medical Received FDA Clearance; UK Pioneers First Skull-Mounted Epilepsy Device for Child; The Initiation of a Significant Clinical Trial of 3d Printed Models; Esaote Unveiled the Cutting-Edge Mylab™E80 @Sirm Ultrasound Device For 2024; Medasense Unveiled a Transformative Partnership With Nihon Kohden Corporation

Alcon's Newest Technological Marvels, Unity VCS, and Unity CS, Achieved 510(k) Clearance From the U.S. FDA, Paving the Way for New Advancements On June 24, 2024, Alcon, the foremost name in eye care with a mission to help people see brilliantly, revealed that the U.S. Food and Drug Administration (FDA) had given 510(k) clearance to its UNITY® Vitreoretinal Cataract System (VCS) and UNITY® Cataract System (CS). These cutting-edge technologies are the first releases from Alcon's much-anticipated Unity portfolio, setting a new standard in eye care innovation. “At Alcon, we have a long legacy of involving our customers throughout the research and development ...

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Bristol Myers Squibb’ Karuna Therapeutics Buyout; Orchard Therapeutics’ Lenmeldy FDA Approval; Madrigal Pharmaceuticals’ Rezdiffra FDA Approval; AstraZeneca’s Acquisition of Amolyt Pharma; Prilenia’s Pridopidine EU Marketing Approval

MedTech News for Allumiqs, MangoRx, Ventris

Allumiqs and Prolytix’s Partnership; Setpoint Medical’s Neuroimmune Modulation Platform gets FDA Breakthrough Designation; MangoRx Launches ‘PRIME’ with FDA-approved TRT; SeaStar Medical Updates Quelimmune Commercial Launch; Ventris Medical Gains 510(k) for Amplify® Bone Graft Putty

Pharma News for BeiGene, GSK, Sandoz, Travere

BeiGene’s BRUKINSA Gets FDA Accelerated Approval; GSK’s Positive Results in DREAMM-8 Phase III; Sandoz’s Denosumab Biosimilars FDA Approved; Terns Pharma’s TERN-701 Receives Orphan Drug Designation; Wegovy® Approved in US for Overweight Cardiovascular Risk; Travere Therapeutics Submits sNDA for FILSPARI IgAN Full Approval

MedTech News for Philips, Boston Scientific, Varian

Philips Teamed with SyntheticMR; BioPhotas’s Celluma Light Therapy; Boston Scientific’s AGENTTM Drug-Coated Balloon; Varian’s TrueBeam and Edge Radiotherapy Systems; Carthera’s Brain-Blood Barrier Trial; Prototype Device Effectively Treated Multiorgan Failure

Pharma News for Bayer, AstraZeneca, AbbVie, A2 Bio

Bayer’s New Cardiology Drug Acoramidis; Two Datopotamab Deruxtecan Applications Validated in the EU; AbbVie and OSE Immunotherapeutics Announce Announces Partnership; vTv Therapeutics Makes Major Move With Cadisegliatin; A2 Bio Scores FDA Orphan Drug Designation for its Therapy, A2B530; FDA Fast Track Designation for AlloNK® in Lupus Nephritis

Pharma News for GSK, Sanofi, Biogen, Artiva

Survodutide Phase II trial Shows Groundbreaking Results in Liver Disease; GSK Announces Positive Headline Results from EAGLE-1 Phase III Trial; Dupixent sBLA Accepted for FDA Priority Review; Biogen’s QALSODY Received Positive Opinion from CHMP; FDA Granted Orphan Drug Designation to Immune-Onc’s IO-202; Artiva Biotherapeutics’s AlloNK® in Lupus Nephritis

Pharma News for Novartis, Iovance, Certa, Innovent

FDA Approves Xolair for Food Allergies; FDA Accelerated Approval for Iovance’s AMTAGVI; Astellas and Kelonia Enter into Research and License Agreement; Fast Track Designation to Certa’s FT011; Innovent Announces Phase 3 Clinical Trial Updates for IBI311; Orphan Drug Designation to Cardiol’s Pericarditis Drug Candidate

MedTech News for ResMed, Masimo, Viz.Ai, UroMems

Tandem’s Automated Insulin Patch Pump; ResMed’s Bilevel Sleep Respiratory Devices; Masimo’s First Over-The-Counter Fingertip Pulse Oximeter; Viz.Ai Algorithm for Quantifying Intracerebral Hemorrhage; Canary Medical’s Heart Sound Monitor; UroMems’ Smart Urinary Sphincter System

Pharma News for GSK, Gilead, CSL, CymaBay

GSK Receives FDA Fast Track Designation for Bepirovirsen; Gilead to Acquire CymaBay Therapeutics; CSL Announces Top-line Results from the Phase III AEGIS-II Trial; Ruxoprubart Scores FDA Orphan Drug Designation for PNH Treatment; CymaBay Announces FDA Acceptance of NDA and Priority Review for Seladelpar; Biogen Received European Commission Approval for SKYCLARYS

MedTech News for Dexcom, Philips, Toku, Carthera

Cerenovus Launched Next-Gen Stroke Revascularization Catheter; Dexcom Launched New ONE+ CGM System; Philips Received the US FDA Nod for Latest Intellivue Patient Monitor Software; Toku Obtained CE and UKCA Marks for AI Cardiovascular Risk Assessments; Genesis MedTech Completed Enrollment in TAVR Trial; Carthera’s Ultrasound Drug Delivery Trial

Navigating the Healthcare Horizon: Odyssey of Mergers, Funding, and Acquisitions in 2024

Pharma News For Astellas, AnaMar, Biosyngen

4DMT Presents Data From Phase II PRISM Clinical Trial; Adaptimmune Announces FDA Acceptance of Biologics License Application for Afami-cel; Astellas Submits Supplemental New Drug Application in Japan for PADCEV with KEYTRUDA; AnaMar Announces US and EU Orphan Drug Designation for AM1476; Biosyngen Announces FDA Fast Track Designation for BST02; Acepodia Announces FDA Clearance of IND Application for ACE2016

MedTech News for Samsung, BIOCORP, CroiValve, FastWave Medical

Samsung Partnered with Lunit; Boston Scientific Launched VersaVue single-use Flexible Cystoscope; Element Science’s Patch-wearable Cardioverter Defibrillator; BIOCORP Received 510(k) FDA Clearance for SoloSmart; FDA IDE for CroiValve’s Tricuspid Heart Valve; FastWave Medical’s First-in-human Study of its IVL Tech

Pharma News for Merck, BMS, Sanofi, Juvena

Merck’s KEYTRUDA as Adjuvant Therapy for RCC Patients; BMS Receives Positive CHMP Opinion for CAR T Cell Therapy Abecma for Multiple Myeloma; FDA Approves Dupixent for Eosinophilic Esophagitis; Juvena Receives FDA Orphan Drug Designation for JUV-161; European Commission Authorizes GSK’s Omjjara; ENHERTU Granted Priority Review in the US for for metastatic HER2-positive Solid Tumors

MedTech News for AngioDynamics, Enhatch, AbSolutions

FDA Breakthrough Device Designation to Pi-Cardia’s ShortCut; AbSolutions Med’s REBUILD Bioabsorbable Abdominal Wall Closure Device; AngioDynamics Announces FDA 510(k) Clearance of Auryon XL Radial Access Catheter; Enhatch Announces FDA Clearance for a TKA Patient-Specific Instrumentation System

Pharma News for Exelixis, AstraZeneca, Kyverna

BMS, and Exelixis’s Opdivo + CABOMETYX in First-Line Advanced Renal Cell Carcinoma; AIRSUPRA Now Available as the First and Only FDA-approved Anti-inflammatory Rescue Option for Asthma; AstraZeneca’s Voydeya Receives First-ever Regulatory Approval; EMA Grants ODD to GC Biopharma’s Sanfilippo Syndrome (Type A) Treatment; FDA Approves NRx Pharma’s IND Application of NRX-101; FDA Fast Track Designation to Kyverna’s KYV-101

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