Oncology Highlights – 30/07/2018

Notizia - Recent Pharma, Healthcare and Biotech Happenings

AstraZeneca’s Voydeya FDA Approval; Akebia’s Va...

Voydeya Receives FDA Approval as Supplemental Treatment with Ravulizumab or Eculizumab for Managing Extravascular Hemolysis in Adult Patients with PNH Voydeya (danicopan) has received approval in t...

Apr 02, 2024

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TELA Bio Launched Hernia Mesh Fixation Devices; Stryker Acquisition of SERF SAS; FDA 510(k) Clearance for RedDrop Dx’s Blood Collection Device; FDA 510(k) Clearance for Next Generation Shaw Scalpel; LivaNova’s Sleep Apnoea Device Trial; Nanodropper’s Positive Impact on Glaucoma Treatment

TELA Bio Launched FDA-approved Hernia Mesh Fixation Devices  On March 21, 2024, TELA Bio, Inc., a medical technology firm, launched its FDA-approved LIQUIFIX devices for hernia repairs in the United States. The LIQUIFIX FIX8™ and LIQUIFIX Precision™ are specifically engineered for laparoscopic and open femo...

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Regeneron’s Odronextamab BLA; Novo Nordisk’s Cardior Pharmaceuticals Acquisition; Novartis’ Fabhalta CHMP Approval; Idorsia’s TRYVIO FDA Approval; AbbVie’s Landos Biopharma Acquisition

Regeneron Updates Progress on Biologics License Application for Odronextamab Regeneron Pharmaceuticals, Inc. has announced that the FDA has issued Complete Response Letters (CRLs) regarding the Biologics License Application (BLA) for odronextamab in cases of relapsed/refractory (R/R) follicular lymphoma (FL) and...

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Vygon Launched Nutrisafe2 System; Butterfly Network Launched Third-Gen Ultrasound; Cosm Medical Won FDA Clearance; FDA Cleared Sequel Med Tech Automated Insulin Delivery System; IceCure Medical Reported Positive Topline Results; Cerus Announced Positive Results in Blood Purification Trial

Vygon Launched Neonatal Safety in India with Groundbreaking Nutrisafe2 System  On March 15, 2024, Vygon, a leader in the production and marketing of specialized medical equipment, introduced Nutrisafe2, a technological leap forward. This state-of-the-art enteral feeding device for neonates guarantees the sa...

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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

Bristol Myers Squibb Enhances Neuroscience Arm with Karuna Therapeutics Buyout Bristol Myers Squibb has declared the finalization of its purchase of Karuna Therapeutics, Inc. With this acquisition concluded Karuna’s shares are no longer being traded on the Nasdaq Global Select Market, as Karuna is now fully owne...

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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

MangoRx Officially Launches ‘PRIME’ by MangoRx, Powered by Kyzatrex®️ FDA Approved Oral Testosterone Replacement Therapy (TRT) Treatment On March 12, 2024, Mangoceuticals, Inc. unveiled a groundbreaking development eagerly awaited by many: the launch of 'PRIME' by MangoRx, Powered by Kyzatrex®️. This release mar...

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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

BeiGene Receives FDA Accelerated Approval for BRUKINSA in Relapsed/Refractory Follicular Lymphoma BeiGene, Ltd., has declared that the FDA has provided accelerated approval for BRUKINSA® (zanubrutinib) to be used in treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), when used alo...

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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

Philips Teamed with SyntheticMR to Deliver Breakthrough AI-based Quantitative Brain Imaging in MR to Advance Neurology Care For Patients On March 01, 2024, Philips in collaboration with SyntheticMR announced the launch of Smart Quant Neuro 3D, a significant advancement in objective decision support for diag...

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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

Acoramidis Joins Bayer's Robust Lineup, Boosting Cardiology Solutions Bayer has obtained the exclusive rights to market acoramidis in Europe from Eidos Therapeutics Inc., BridgeBio International GmbH, and BridgeBio Europe B.V. Acoramidis, a highly potent and selective small molecule given orally, functions as a ...

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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

Survodutide Phase II trial Shows Groundbreaking Results in Liver Disease due to MASH, with Significant Improvements in Fibrosis Boehringer Ingelheim has reported that in a Phase II trial, a significant proportion of adults treated with survodutide (BI 456906), up to 83.0%, showed a notable enhancement in metabol...

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Dry Age-related Macular Degeneration (Dry AMD), also called atrophic AMD, is the most common form of.....

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Major Depressive Disorder (MDD), also known as clinical depression, is a severe, debilitating and fr.....

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Neurofibromatosis is a progressive and autosomal dominant inherited disorder of the nervous system w.....

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BK Virus Infection , a member of the polyomavirus family, is typically associated with patients who .....

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Neuromyelitis Optica Spectrum Disorder (NMOSD), also known as Devic disease, is a chronic disorder o.....

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Axial Spondyloarthritis (axSpA) is an umbrella term for a form of inflammatory form of arthritis ass.....

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