Oncology Highlights – 30/07/2018

Notizia - Recent Pharma, Healthcare and Biotech Happenings

FDA Grants Priority Review for Zolbetuximab BLA...

Astellas Announces FDA Grants Priority Review for Zolbetuximab Biologics License Application Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the company's B...

Jul 11, 2023

MedTech News for Enovis, Dexcom, Abbott, Elios
Enovis Acquires Novastep; Rockwell Medical Announced Collaboration with B. Braun; Dexcom G7 Received Health Canada Approval for Next-Generation CGM; Abbott’s World’s First Dual Chamber Leadless Pacemaker; Elios Vision’s Pivotal Trial of ELIOS; Synergy Spine’s Synergy Disc 2-Level IDE Trial

Enovis completed the acquisition of Novastep On June 29, 2023, Enovis, one of the largest orthopedic device companies in the world, announced that the company had completed the purchase of Novastep and its foot and ankle minimally invasive surgical (MIS) platform, which was first announced in April 2023.  ...

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Pharma News for BioMarin, CellTrans, Genenta, GSK
First Gene Therapy for Severe Hemophilia A; FDA Approves CellTrans’s Type 1 Diabetes Cellular Therapy; FDA Approve Amneal’s Parkinson’s Drug Over Safety Concerns; NLS Pharmaceutics’s Phase III Clinical Trials of Quilience; Genenta Science’s Temferon for the Treatment of Glioma; FDA Fast Track Designation to GSK’s Gonorrhea Drug

FDA Approves First Gene Therapy for Severe Hemophilia A BioMarin Pharmaceutical Inc., a global biotechnology company dedicated to transforming lives through genetic discovery, announced that the US Food and Drug Administration (FDA) has approved ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy for the tr...

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MedTech news for Eko. Haemonetics. Roche, Medtronic, Biodesix
GE HealthCare, DePuy Synthes Announced Collaboration; Eko Health Launched CORE 500 Digital Stethoscope; Haemonetics’s NexSys PCS Plasma Collection System; Roche’s Alzheimer’s Disease Cerebrospinal Fluid (CSF) Assays; Medtronic’s MiniMed 780G system; Biodesix’s VeriStrat Blood-Based Host Immune Classifier

GE HealthCare Announced Collaboration with DePuy Synthes to Bring Advanced 3D Precision Imaging Innovation to Spine Practices in the United States On June 21, 2023, GE HealthCare entered into a distribution agreement with DePuy Synthes, the Orthopaedics division of Johnson & Johnson, to bring GE HealthCare’s...

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Pharma News for Pfizer, Sarepta, FibroGen, Erasca
FDA Approves Jardiance for Type 2 Diabetes; FDA Approves Pfizer’s LITFULO for Alopecia Areata; Sarepta Therapeutics’s ELEVIDYS Approval; Tonix Pharmaceuticals to Acquire Two Migraine Products from Upsher-Smith; FibroGen’s Phase 3 ZEPHYRUS-1 Study of Pamrevlumab; FDA Orphan Drug Designation to ERAS-801 for Malignant Glioma

FDA Approves Jardiance for the Treatment of Type 2 Diabetes in Children 10 Years and Older Boehringer Ingelheim and Eli Lilly and Company announced that the FDA has approved Jardiance® (empagliflozin) 10 mg and 25 mg tablets to decrease blood sugar together with diet and exercise in children 10 years and older w...

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MedTech News for Surmodic, Galvanize, STERIS, Orthofix
Orthofix Launched WaveForm A; BD Entered into Agreement with STERIS; Surmodics’s SurVeil™ Drug-Coated Balloon; Cardio Flow Design’s 4D Flow MRI Blood Flow Analysis Software; Galvanize Therapeutics’s RheOx® System; AWAK and SGH’s Wearable Peritoneal Dialysis Device Trial

Orthofix Launched WaveForm A – 3D Printed Anterior Lumbar Interbody On June 19, 2023, Orthofix Medical Inc., a leading global spine and orthopedics company, launched WaveForm® A, an interbody for Anterior Lumbar Interbody Fusion (ALIF) procedures. For the treatment of patients who require fusion due to degenerat...

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Pharma News for GSK, Roche, Avita, Ipsen
FDA Extended the Review Period for Momelotinib; FDA Approves Roche’s Columvi; Avita Medical Obtains FDA Approval of RECELL; FDA Approves Odevixibat for ALGS; TME Pharma Receives IND Approval for NOX-A12; Aldeyra’s Phase 3 INVIGORATE‑2 Trial of Reproxalap

GSK Announces Extension of FDA Review Period for Momelotinib After all, GSK will not hear from the FDA this month about its marketing application for momelotinib as a therapy for anemia in myelofibrosis patients. The pharmaceutical company announced that the US Food and Drug Administration has extended the drug'...

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MedTech News for Endologix, SunMed, BD
Centinel Spine’s Prodisc C Match-the-Disc Cervical TDR System; Reflow Medical’s DEEPER OUS Trial; FDA Approval to Endologix’s Detour System; FDA Clearance to Smith+Nephew’s Shoulder Replacement System; SunMed Acquired Avanos’s Respiratory Health Business; BD’s Automate Clinical Flow Cytometry

Centinel Spine® Completed Enrollment in First-of-its-Kind 2-Level IDE Trial Evaluating prodisc® C Match-the-Disc™ Cervical TDR System On June 13, 2023, Centinel Spine®, LLC, a leading global medical device company addressing cervical and lumbar spinal disease by providing the most robust and clinically-pr...

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Pharma News for Kyverna, Annovis, Astellas, FibroGen
FDA Fast Track Status to Kyverna’s KYV-101; Annovis’s Phase III Study for Buntanetap; Gilteritinib Demonstrated Benefit in AML Patients; FDA Orphan Drug Designation to DTx Pharma’s DTx-1252; FibroGen’s LELANTOS-1 Phase 3 Clinical Study Result

FDA Grants Fast Track Status to KYV-101 for Refractory Lupus Nephritis Treatment Kyverna Therapeutics announced that the FDA has given Fast Track status to KYV-101, a treatment for patients suffering from resistant lupus nephritis (LN). KYV-101 is an innovative therapy that uses anti-CD19 chimeric antigen recept...

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MedTech News for Olympus, Artelon, Masimo, Gore
Olympus’s Next Generation Electrosurgical Generator; Biocomposites Acquires Artoss GmbH; Artelon’s FlexBand, FlexPatch, and FlexBand Plus; Masimo’s Radius VSM; Gore’s GORE VIAFORT Vascular Stent; Synergy Spine Solutions’s 1-Level IDE Trial

Olympus Launched Next Generation Electrosurgical Generator On June 06, 2023, Olympus Corporation, a global medical technology company, launched its newest electrosurgical generator, ESG-410 for use in the treatment of bladder cancer and enlarged prostate. By offering a variety of resection loops, band electro...

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US Cancer Statistics show that more than half a million suffer from this disease, which is the secon.....

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Medical device manufacturing and development is a high-capital demanding endeavor and therefore the .....

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Lyme disease is a vector-borne infectious disease that spreads primarily by the bite of a tick (also.....

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Osteosarcoma is a kind of bone cancer that originates from the cells that form bones. It is often fo.....

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HIV-associated lipodystrophy (HAL), is a condition characterized by the redistribution of adipose ti.....

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Virtual clinical trials (VCTs) are site-less clinical trials, which utilizes technology along with t.....

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