Oncology Highlights – 30/07/2018

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Zepp Health Launched OTC Hearing Aids; Neoss La...

Zepp Health Launched a New Line of OTC Hearing Aids for its Zepp Clarity Brand On September 19, 2023, Zepp Clarity, a smart hearing solutions brand owned by Zepp Health, a health technology company...

Sep 21, 2023

Pharma News for Almirall, GSK, Cellectar
FDA Approves Ojjaara for Myelofibrosis; EMA Grants PRIME Designation to Iopofosine I-131; EBGLYSS Receives Positive CHMP Opinion; FDA Accepts Resmetirom NDA; FDA Fast Track Designation to KT-333 for PTCL; RedHill Announces FDA sNDA Approval for Talicia®

EBGLYSS Receives Positive CHMP Opinion for Moderate-to-Severe Atopic Dermatitis Almirall S.A. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the marketing authorization of EBGLYSS (lebrikizumab) for the treatment o...

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Medtech news for Mindray, Alveofit, Limaca
Mindray’s 2-in-1 Handheld Ultrasound Device; NuVasive’s Precice Bone Transport System; FDA for alveofit’s alveoair; FDA 510(k) Clearance Limaca’s Precision GI™ Endoscopic Biopsy Device; Evolution Optiks’s Neuro-Optical Testing Device; Moderna Expanded Field of mRNA Medicine

Mindray Launched Groundbreaking 2-in-1 Handheld Ultrasound Device with Multi-device Connectivity  On September 7, 2023, Mindray, a global leader and developer of healthcare solutions and technologies in ultrasound, patient monitoring, and anesthesia announced the release of its new imaging solution, the TE ...

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Pharma News for BMS, Alnylam, MaaT Pharma
BMS’s LPA1 Antagonist; Alnylam’s KARDIA-1 Phase 2 Study; Day One Biopharma Sought FDA Approval for Tovorafenib; EMA Orphan Drug Designation to MaaT Pharma’s MaaT033; Lundbeck and Otsuka Announce Topline Results from Two Phase III Trials of Brexpiprazole + Sertraline; Phase III CheckMate – 227 Trial Show Durable, Long-Term Survival with Opdivo Plus Yervoy

Bristol Myers Squibb’s Investigational LPA1 Antagonist Reduces Rate of Lung Function Decline in Progressive Pulmonary Fibrosis Cohort of Phase II Study BMS-986278, a potential first-in-class oral lysophosphatidic acid receptor 1 (LPA1) antagonist, was studied in patients with progressive pulmonary fibrosis (PPF)...

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MedTech News for Vitestro, Signia, Synchron
Boston Scientific’s WATCHMAN FLX™ Pro; Quest Diagnostics’s AAV Test; Vitestro Started A.D.O.P.T. Clinical Trial; Signia Introduces Hearing Aids; Laborie Medical to Acquire Urotronic; Synchron’s Brain-Computer Interface Trial

Quest Diagnostics Granted FDA Breakthrough Designation for its Adeno-associated virus (AAV) Test  On August 30, 2023, Quest Diagnostics announced that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA). The enzyme-linked immunosor...

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Pharma News for Faron, Roche, Ergomed, Menarini
Daiichi Sankyo’s Trastuzumab Deruxtecan; ODD to Bexmarilimab for AML; Roche’ Alecensa; Ergomed Aims To Go Private; Tagraxofusp Receives ODD in Japan for BPCDN; FDA Fast Track Designation to Abliva’s KL1333

FDA Grants Breakthrough Therapy Designations to Trastuzumab Deruxtecan for HER2+ Solid Tumors, Including mCRC ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy Designations (BTDs) in the United States for the treatment of adult patients with unresectable or metastati...

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MedTech News for GE, Medtronic; Epineuron
GE HealthCare Launched CardioVisio; J&J’s Elita Laser Correction Platform; ICU Medical’s Plum Duo Infusion Pump and LifeShield Infusion Safety Software Update; Medtronic’s Inceptiv SCS with Closed-Loop Sensing to Treat Chronic Pain; Boston Scientific’s FARAPULSE Pulsed Field Ablation System; Epineuron’s REGAIN Trial

GE HealthCare Launched CardioVisio for Atrial Fibrillation, a Digital, Patient-Centric Clinical Decision Support Tool to Enable Precision Care On August 24, 2023, GE HealthCare launched CardioVisio for Atrial Fibrillation (AFib), a digital tool designed to assist clinicians in visualizing longitudinal data relev...

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Pharma News for Nexcella, Janssen, Alentis
FDA Approves BMS’s Reblozyl for MDS; FDA Awards Orphan Drug Designation to NXC-201; Janssen Submits Supplemental NDA for Full Approval of BALVERSA; FDA Grants Fast Track Status to ALE.C04; FDA Orphan Drug Designation to Faron’s Bexmarilimab; FDA Clears IND Application for AHB-137

FDA Approves Bristol Myers Squibb’s Reblozyl as First-Line Treatment of Anemia in Adults with Lower-Risk MDS Who May Require Transfusions Bristol Myers Squibb announced that the Food and Drug Administration (FDA) has approved Reblozyl® (luspatercept-aamt) for the treatment of anemia in adult patients with very l...

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MedTech News for Mammotome, Geneseeq, BaroPace
Smith+Nephew’s Hip Arthroplasty System; Mammotome Launched the HydroMARK Plus Breast Biopsy Site Marker; FDA Clearance for Pioneering MARS System; CE Marks for NGS-based Test Kits; BaroPace Updated on Non-Pharmacologic Hypertension and Heart Failure Treatment Trial; Quanta Completed Enrollment in Home Run Study

Smith+Nephew Launched Hip Arthroplasty System in India  On August 17, 2023, The London-based orthopedic device maker Smith+Nephew announced the launch of its OR3O dual mobility system for use in primary and revision hip arthroplasty in India. The dual mobility implants have a smaller-diameter femoral hea...

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Pharma News for Gilead, Incannex, Avidity
Eylea HD Injection 8 Mg Approved By FDA; Veopoz Receives FDA Approval for CHAPLE Disease Treatment; FDA Places Second Partial Clinical Hold on AML Enrollment for Magrolimab Trials; FDA Approval to Incannex’s Sleep Apnoea Clinical Trial; FDA Orphan Drug Designation to Avidity’s AOC 1044; Orphan Drug Designation to CanariaBio’s MAb-AR20.5

Eylea HD Injection 8 Mg Approved By FDA for Treatment of Wet AMD, DME, and Diabetic Retinopathy The FDA has approved Regeneron Pharmaceuticals’ EYLEA HD (aflibercept) Injection of 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retin...

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Myocardial Infarction
Myocardial Infarction...

Myocardial infarction (MI), colloquially known as “heart attack” is caused by decreased or compl.....

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Acute Ischemic Stroke (AIS)
Acute Ischemic Stroke (AI...

Acute ischemic stroke (AIS) is a medical emergency caused by decreased blood flow to the brain, whic.....

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Rheumatoid Arthritis
Rheumatoid Arthritis...

Rheumatoid Arthritis (RA) is a chronic, inflammatory autoimmune disease that leads to progressive an.....

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