Notizia - Recent Pharma, Healthcare and Biotech Happenings

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Baxter Introduced New Injectable Pharmaceuticals to US Market; Bayer and Hologic Collaborated to Deliver Contrast-Enhanced Mammography; Labcorp Received FDA Emergency Use Authorization for Mpox PCR Test Home Collection Kit; Onkos Surgical Won FDA De Novo Nod For Antibacterial-Coated Orthopedic Implants; Heartbeam Presented Positive Results On Its Artificial Intelligence Capabilities For Detecting Arrhythmias; Cognito Therapeutics Showed Positive Non-Invasive Neuromod Results 

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Pharma News Sibionics, Abbott, CleanNA, Orthofix

SIBIONICS’s Ground-breaking GS1 Continuous Glucose Monitoring System; Abbott’s HPV Test to Run on Alinity m; CleanNA’s CE-IVD Molecular Diagnostics Product; Orthofix’s WaveForm L Interbody System; Alucent Biomedical’s AlucentNVS Technology; Surmodics’s TRANSCEND Trial Data

Pharma News for Bayer, Merck, Ayala, GARDP, AstraZeneca

New Asundexian Phase III Study Result; Zibotentan/Dapagliflozin Combination Demonstrated Significant Albuminuria Reduction Chronic Kidney Disease; Orphan Drug Designation to Rhenium Obisbemeda; FDA Approves Merck’s KEYTRUDA Plus Gemcitabine and Cisplatin for Biliary Tract Cancer; Orphan Drug Designation to Ayala’s AL102; GARDP Announces Successful Phase 3 Trial of of Uncomplicated Gonorrhea

MedTech News for Laborie, Sirtex, Paige, Neurovalens

Laborie Medical Acquired Urotronic; Sirtex’s LAVA Liquid Embolic System; Paige’s Cancer Detection in Breast Lymph Nodes; FDA Clearance to Neurovalens’s Non-Invasive Insomnia-Treating Device; Recor Medical’s Renal Denervation System; Pulsecare Medical’s nsPFA Clinical Trial Short-term Follow-up Results

Molecular Modeling Market Analysis

Revolutionizing Drug Discovery and Beyond: The Power of Molecular Modeling

Pharma News for GSK, Roche, Eli Lilly, Coherus

Phase III RUBY Trial of Jemperli Plus Chemotherapy Updates; FDA Approves Roche’s Vabysmo for RVO; FDA Grants Priority Review to Tovorafenib Low-Grade Glioma; FDA Approves Lilly’s Omvoh; FDA Approves Toripalimab for Nasopharyngeal Carcinoma; FDA Fast Track Designation to ONCT-534 R/R mCRPC

MedTech News for Olympus, Abbott, Cardio Flow

Cardio Flow’s FreedomFlow Orbital Atherectomy Peripheral Platform; Medtronic’s Aurora EV- ICD System to Treat Arrhythmias; GE Healthcare and Novo Nordisk Announces Collaboration; Olympus’s EVIS X1 Endoscopy System; Medtronic’s Evolut TAVR Platform Outperformed Surgery with Sustained Valve Performance; Abbott’s Minimally Invasive Devices for People with Leaky Heart Valves

Pharma News for Pfizer, UCB, BioMarin

FDA Approves PENBRAYA for Most Common Serogroups Causing Meningococcal Disease; BIMZELX Approved Moderate to Severe Plaque Psoriasis; FDA Approves BioMarin’s VOXZOGO; FDA Fast Track Designation to ANPD001 for Parkinson’s Disease; UCB Announces FDA Approval of ZILBRYSQ; EMA Granted Orphan Drug Designation to Lisata’s LSTA1

MedTech News for Mindray, DuPont, Praxis

Mindray Collaborated with Edwards Lifesciences; DuPont’s Low-Cyclics Silicone Soft Skin Adhesive; GE HealthCare’s Allia IGS Pulse; Praxis Medical’s EndoCore EBUS-TBNA Biopsy Device; Visioneering’s PROTECT Clinical Trial; SynerFuse’s e-TLIF procedure

Pharma News for SELLAS, BMS, MimiVax

Novo Nordisk to Acquire Ocedurenone; FDA Awards Orphan Drug Designation to SLS009 in AML; FDA Approves Adjuvant Nivolumab in Completely Resected Stage IIB/C Melanoma; Fast Track Designation to South Rampart Pharma’s SRP-001; TAGRISSO + Chemotherapy Granted Priority Review in the US; Fast Track Designation to SurVaxM for Glioblastoma

MedTech News for Everly, Sanguina, Biotronik, Contego

B. Braun’s Introcan Safety 2 IV Catheter; Everly Health’s At-Home Collection Kidney Health Test; FDA Clearance to Sanguina’s AnemoCheck Home; FDA Clearance for the DePuy’s TriALTIS™ Spine System; Biotronik’s Spinal Cord Stimulation Tech; Contego Medical’s Performance III Direct Transcarotid Access Stenting Trial

Pharma News for Amgen, Anaptys, Sanofi, Boehringer

Amgen to Acquire Horizon Therapeutics; Sanofi and Teva Announce Collaboration; Boehringer Obesity Drug Trial Update; FDA Places Partial Clinical Hold on IND for Lacutamab in CTCL/PTCL; Anaptys Announces Phase 3 Clinical Trial Results of Imsidolimab; Orphan Drug Designation to GC Biopharma’s GC1126A

MedTech News for Boston Scientific, Enable Injections

Boston Scientific’s Insertable Cardiac Monitor; Phillips-Medisize Teamed up with GlucoModicum; Boston Scientific’s Intravascular Ultrasound System; Enable Injections Received First US FDA Approval; Amber Implants’s VCFix® Spinal System; Loci Orthopaedics’s “InDx” Thumb Base Joint Replacement Study

Pharma News for AbbVie, Novartis, Avenge Bio, Eli Lilly

AbbVie Presents Phase III CANOVA Study Results; Novartis’ Iptacopan Shows Promise in Phase III Study; Fast Track Designation to AVB-001 for R/R Platinum-Resistant Ovarian Cancer; FDA Issues Complete Response Letter for Lebrikizumab; Nedosiran Approveed for Primary Hyperoxaluria Type 1; Orphan Drug Designation to BDC-1001 for Gastric Cancers

MedTech News for Orthofix, Medtronic, MicroVention

Orthofix Launched the Galaxy Fixation Gemini System; Oxford Biodynamics Launched the EpiSwitch Prostate Screening Blood Test; CE Mark for the Medtronic’s New Simplera CGM; FDA 510(k) Clearance to MicroVention’s SOFIA™ EX 5F 115cm; SHL Telemedicine’s SmartHeart® Technology; Cardiosense’s Nationwide Heart Failure Study

Pharma News for AbbVie, BioArctic, Coherus

LEQEMBI Intravenous Infusion Approval; Novartis’ Presented Updates on Lutathera; FDA Accepts Submission to Add PH-ILD to YUTREPIA Label; FDA Issues CRL to BLA for Pegfilgrastim-cbqv; FDA Fast Track Designation to Therpay, MWTX-003; EC Approves TEPKINLY (epcoritamab) for R/R DLBCL

MedTech News for Neoss, Tasso, Neuralink, Zepp

Zepp Health Launched OTC Hearing Aids; Neoss Launched NeoScan 2000; FDA Clearance for AI-Assisted Sleep Monitoring Device Dreem 3S; Tasso Received CE Mark Certification for Tasso+; Neuralink’s First-in-human BCI trial; Creative Medical to Initiate a Phase I/II Clinical Trial of StemSpine

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