Oncology Highlights – 30/07/2018

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Laborie Launched alpHaONE; Cadwell Launched Arc...

Sonex Health Announced US Clinical Study to Report Safety and Effectiveness of Office-based Carpal Tunnel Release System with Ultrasound Guidance  On March 30 2023, Sonex Health, Inc., a leade...

Apr 06, 2023

Pharma News and updates for HUTCHMED, Cytokinetics, Astellas, Seagen, Nanoscope Therapeutics, Cabaletta Bio, Decibel Therapeutics
HUTCHMED’s NDA Submission to FDA for Fruquintinib; Cytokinetics to Discontinue ALS Drug Candidate Following Phase III Trial Failure; Enfortumab Vedotin + Pembrolizumab Approved for Urothelial Carcinoma; Nanoscope Gene Therapy Clears Phase II Retinitis Pigmentosa Trial; FDA Clearance to Cabaletta Bio’s IND Application for CABA-201 for SLE Treatment; European Orphan Drug Designation to Gene Therapy Candidate DB-OTO

HUTCHMED Completes Rolling Submission of NDA to FDA for Fruquintinib HUTCHMED (China) Limited announced the completion of the rolling submission of a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") for fruquintinib, its highly selective and potent oral inhibitor of VEGFR-1,...

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MedTech News and Updates for Mindray, Getinge, Gore, CoreLink
Mindray’s TE Air Handheld Ultrasound System; Getinge’s iCast™ Covered Stent System; Clinical Trial Update for the FLASH Proton Therapy for Cancers in the Bones; Gore’s Gore® Viafort Vascular Stent IVC Study; CoreLink’s Siber® Ti—3D Printed SI Joint Fusion System; USound and Partners’s Next-Generation Over-the-Counter Hearing Aids

TE Air Handheld Ultrasound System Launched by Mindray  On March 16, 2023, Mindray, a China-based company announced the launch of TE Air, a high-quality, wireless, handheld, portable ultrasound device that is designed to easily fit into a pocket. Built with Mindray’s eWave platform and second-generation S...

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Pharma News and Updates for Novartis, Pharming, Cyclerion, Iovance, BPGbio
Novartis Announces the Positive Results of Phase III NATALEE Trial Evaluating Kisqali; FDA Approves Pharming’s Joenja for APDS; FDA Orphan Drug Designation to Cyclerion’s Zagociguat; Iovance Completes BLA Submission for Lifileucel in Advanced Melanoma; BPGbio Announces Partnership with debra of America

Novartis Announces the Positive Results of Phase III NATALEE trial Evaluating Kisqali Novartis announced positive topline results from an interim analysis of NATALEE, a Phase III trial evaluating Kisqali® (ribociclib) plus endocrine therapy (ET) in a broad population of patients with hormone receptor-positive/hu...

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More Views & Analysis

Latest MedTech News and Updates for Viz.ai, BrainTale, Medtronic, NVIDIA, Median Technologies
Viz.ai’s AI Algorithm for Abdominal Aortic Aneurysm; BrainTale Unveils the New Version of Its Digital Biomarkers Platform brainTale-care; Medtronic and NVIDIA Announces Collaboration; Median Technologies Announces Update for its iBiopsy Lung Cancer Screening CADe/CADx Software as Medical Device

Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm On March 21, 2023, Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, announced it had received U.S. Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to ...

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Pharma News and Updates for AbbVie, Arrowhead Pharma, Novartis, FORE Biotherapeutics, Ellipses Pharma, Karuna Therapeutics
AbbVie Announces Results of Study Evaluating SKYRIZI; FDA Fast Track Designation to Arrowhead’s ARO-APOC3; FDA Approves Dabrafenib Plus Trametinib for BRAF V600E–Mutated Low-Grade Glioma; FDA Grants ODD to Novel BRAF Inhibitor for Brain/CNS Malignancies; EP0042 Wins FDA Orphan Drug Status; Karuna Therapeutics Announces Results from Phase 3 EMERGENT-3 Trial of KarXT in Schizophrenia

AbbVie Announces Positive Results of Study Evaluating SKYRIZI in Plaque Psoriasis Patients AbbVie announced new 52-week data from an open-label, a single-arm study demonstrating improved plaque psoriasis signs and symptoms in a difficult-to-treat patient population who received SKYRIZI® (risankizumab), an IL-23 ...

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MedTech News and Update for Sight Sciences, HeartBeam, LIVMOR, Occlutech, PADM Medical, Kardium, LivaNova
Sight Sciences’s Ergo-Series of the OMNI® Surgical System; HeartBeam to Acquire LIVMOR’s Assets; Occlutech Atrial Flow Regulator (FROST-HF) Study Updates; US FDA 510(k) Clearance for PADM Medical’s PRECISION ECO; Kardium ‘s Pulsed-Field Ablation Study; US FDA 510(k) Clearance for LivaNova’s Essenz Heart-Lung Machine

Ergo-Series of the OMNI® Surgical System Launched by Sight Sciences On March 9, 2023, Sight Sciences, Inc., an eyecare technology company focused on developing and commercializing innovative technology, providing solutions for transforming care and improving patients' lives, announced the launch of the Ergo-Seri...

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Pharma news and updates for Roche, Acadia, Shorla Oncology, Calliditas, Mesoblast, Sanofi, Provention Bio
Sanofi to Acquire Provention Bio; USFDA Committee Votes in Favor Roche’s Polivy; FDA to Review Mesoblast’s GvHD Drug; FDA Approves Acadia’s Daybue ; FDA Approves Nelarabine Injection; Calliditas’s Nefecon Trial Reuslt in IgA Nephropathy

Sanofi to Acquire Provention Bio for USD 2.9 Billion Sanofi and Provention Bio, Inc., a publicly traded biopharmaceutical company based in the United States focused on intercepting and preventing immune-mediated diseases such as type 1 diabetes (T1D), have agreed to acquire Provention Bio, Inc. for $25.00 per sh...

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MedTech News for Artica Systems, Nevro, Stratus® Medical, Restore Medical, Respiree, Abbott
Artica Systems’s Electric Whole-Body Cryotherapy Machines; Nevro’s Revolutionary HFX iQ™ Spinal Cord Stimulation System; COBRA Study of Stratus® Medical for Nimbus® Radiofrequency Ablation Device; Restore Medical’s CONTRABAND™ System; US FDA 510(k) Clearance for RS001 Cardio-respiratory Wearable; FDA Approval to Abbott’s Traumatic Brain Injury (TBI) Blood Test

New Commercial & Residential Electric Whole-Body Cryotherapy Machines Released by Artica Systems  On March 2, 2023, Artica Systems, an American company with over 20 years of experience in the wellness industry announced the release of a new and innovative 100% electric, whole-body cryotherapy fleet mean...

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Pharma News and Updates for Incyte, Eisai, Biogen, Reata Pharmaceuticals, Genenta Science, Harbour BioMed, Ikena Oncology
Incyte’s Clinical Trial for Myelofibrosis; Eisai and Bioge’s Leqembi; FDA Approves Reata Pharmaceuticals’ SKYCLARYS; Temferon Lands FDA Orphan Drug Status for Glioblastoma; Harbour BioMed Announces Results from Phase III Trial of Batoclimab; FDA Fast Track Designation to Ikena’s AHR Antagonist IK-175

Incyte Halts Phase III Clinical Trial for Myelofibrosis  Incyte announced the termination of Phase III LIMBER-304 trial after the results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC) revealed that the study is unlikely to meet the primary endpoint in the int...

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Toll-like Receptors (TLRs) are a type of pattern recognition receptor (PRR) that recognizes pathogen.....

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Multiple myeloma (MM) is a cancer of the blood that begins in the bone marrow. In myeloma, plasma ce.....

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Peanut Allergy accounts for the majority of severe food-associated allergic reactions. It is strictl.....

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A rare autosomal recessive disorder, Familial chylomicronemia syndrome (FCS), affects 1 in 1 to 2 mi.....

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Gastroesophageal Reflux Disease (GERD, also known as chronic acid reflux) is a digestive disorder in.....

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The Digital Era has officially hit Prime Time. Currently, the potentiality to digitally transform a .....

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