Oncology Highlights – 30/07/2018

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Nkarta’s Anti-CD19 Allogeneic CAR-NK Cell Thera...

FDA Grants Orphan Drug Designation to AUM302 for Neuroblastoma A global clinical-stage biotech company, AUM Biosciences, focused on discovering and developing precision oncology therapeutics, decla...

Dec 06, 2022

Delveinsight
C4X Discovery and AstraZeneca Signs Deal; FDA Rejects Spectrum’s Poziotinib; Orphan Drug Designation to Tenaya’s Gene Therapy; EC Approves Regeneron’s Libtayo; Response Letter to Poziotinib for Metastatic NSCLC Harboring HER2 Exon 20 Mutations; Japan Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer

C4X Discovery Holdings and AstraZeneca Signs Exclusive USD 402 Million Global License C4X Discovery Holdings has signed an exclusive global license with AstraZeneca worth up to USD 402 million for the development and commercialization of the NRF2 Activator program. The agreement will allow AstraZeneca to develop...

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MedTech News for Empatica, ClariPi, Sony, Mainstay Medical, Zimmer
Mainstay Medical’s ReActiv8-C Study; Swing Therapeutics Announced Results from Studies of Stanza; FDA Approves Empatica’s Health Monitoring Platform; FDA Clearance to Persona OsseoTi Keel Tibia System; ClariPi Joins Siemens Healthineers Digital Marketplace; Sony Launches Cloud-based Solution for Flow Cytometry Data Analysis

Mainstay Medical Published Post-Market Clinical Trial Data from Ongoing ReActiv8®-C Study  On November 22, 2022, Mainstay Medical, a medical devices company, announced that the data from the ReActiv8®-C study, a single-centre, real-world study with a one-year clinical follow-up of selected patients, is publ...

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Pharma News Updates Merck, Regeneron, Provention, Ardelyx, AbbVie
FDA Approves Teplizumab to Delay the Onset of Type 1 Diabetes; FDA Backs Ardelyx’s CKD Therapy Xphozah; Merck to Acquire Imago BioSciences; Accelerated Approval to ImmunoGen’s ELAHERE; Regeneron and CytomX Announces Research Collaboration; FDA Grants Priority Review to Epcoritamab R/R LBCL

Merck to Acquire Imago BioSciences, Inc. for USD 1.35 Billion While its rumored acquisition of Seagen has yet to materialize, Merck & Co has continued to bolster its pipeline with smaller transactions, the most recent of which was a USD 1.35 billion agreement to acquire Imago BioSciences and its bomedemstat ...

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MedTech News for Medtronic, Penumbra, and Genesis
Medtronic Launches Infusion Set for Insulin Pumps; Penumbra’s Virtual Reality-Based Rehabilitation System; FDA Approval to Genesis’s Chocolate Touch® Drug-coated Balloon PTA Catheter; FDA Nod to AEYE’s AI-based Autonomous Screening; Alpheus Medical Treats First High-Grade Glioma Brain Cancer Patient with its Proprietary Platform; Karidum’s Next Generation Globe® Pulsed Field System

Medtronic Launches World's First and Only Infusion Set for Insulin Pumps that Doubles Wear Time up to 7 days in the US  On November 15, 2022, Medtronic plc, a global leader in healthcare technology, announced the US launch of the Medtronic Extended infusion set, the first and only infusion set labeled for up to ...

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Delveinsight
Genentech’s gantenerumab Fails in Phase III Trial; CHMP Recommends’ Dupixent; FDA Clears Imfinzi and Imjudo with chemotherapy; NICE Recommends Ipsen’s Cabometyx (cabozantinib); NICE Backs KEYTRUDA; NRG Announces £16 Million Series A Funding; FDA Backs AstraZeneca’s PT027

Genentech’s gantenerumab Fails in Phase III Trial for Alzheimer’s Disease In yet another setback for an amyloid-targeting drug, Roche's Genentech division has reported disappointing top-line results from its highly anticipated phase III trial of gantenerumab in early Alzheimer's disease. The failure is entirely ...

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MedTech News for QuantuMDx, Medtronic, Exactech, and ProciseDx
QuantuMDx & Menarini’s Agreement; TruClear System Launched by Medtronic in India; FDA 510(k) Clearance for TriVerse Primary Knee Replacement System; FDA Clearance to ProciseDx’s Reactive Protein (CRP) Assay and ProciseDx Instrument; Evolution Optiks’s Enrollment of LFR-260 Phoropter in US; Kardium First-in-Human Clinical Study of the New Globe Pulsed Field System

QuantuMDx and Menarini Announced an Agreement for the Distribution of the Q-POCTM Platform On November 2, 2022, QuantuMDx Group Limited, a UK-based developer of transformational Point-of-Need molecular diagnostics, and A.Menarini Diagnostics S.r.I. (Menarini), announced an exclusive distribution agreement for Qu...

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Pharma News for Amgen, AstraZeneca, Sanofi, Anavex, Sensorion, GSK
Amgen’s Olpasiran Candidate; GSK’s Novel Antibiotic for Urinary Tract Infections; AstraZeneca and Sanofi’s Beyfortus Approval; FDA Orphan Designation to Anavex’s Anavex2-73; FDA Rare Pediatric Disease Designation to Sensorion’s OTOF-GT; GSK’s Blenrep Fails in Phase III Trial in R/R Multiple Myeloma

Amgen Reports Promising Mid-stage Results for its Olpasiran Candidate  Amgen has reported encouraging mid-stage results for its olpasiran candidate for lowering lipoprotein(a) - a risk factor for atherosclerotic cardiovascular disease - and now plans to move forward with a phase III program as soon as possi...

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MedTech News for AngioDynamics, Ameda, Pfizer, Cochlear
AngioDynamics’s AlphaVac F18 PE System; Pfizer’s RSVpreF/PF-06928316 Trial; Intelligent Ultrasound’s ScanNav Anatomy PNB; FDA Approves the Cochlear Nucleus 8 Sound Processor; Ameda’s Pearl Breast Pump; J&J to Buy Abiomed; Thermo Fisher Scientific to Acquire The Binding Site Group

AngioDynamics Announces First Patient Enrolled in APEX-AV Study Assessing AlphaVac F18⁸⁵ PE System in Treatment of Pulmonary Embolism On October 31, 2022, AngioDynamics, a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer...

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Pharma News for Actinium, Santhera, Gilead, Seres, BMS, Boehringer
Actinium Announces SIERRA Trial Results; Santhera Seeks FDA Review for Vamorolone; Seres Announces BLA Submission for SER-109; BMS Announces Results of COMMANDS Trial; Boehringer’s PDE4B Moves Late-stage Clinical Testing; FDA Rejects Gilead’s Hepcludex; Approval to J&J’s BCMAxCD3 Bispecific Antibody for Multiple Myeloma; Syncona to Acquire AGTC

Actinium Announces Positive Top-line Results from Pivotal Phase III SIERRA Trial of Iomab-B Actinium Pharma is on track to submit its targeted radiotherapy for AML patients requiring a bone marrow transplant in the United States, boosted by top-line data from a pivotal trial. The SIERRA trial of Iomab-B, an anti...

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Value-Based Healthcare is that healthcare model or a process where the providers, including hospital.....

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Molluscum contagiosum is an inflammation of the skin that is caused by the poxvirus Molluscum contag.....

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Gene Therapy has shown tremendous growth in the past few years. The use of AAV (adeno-associated vir.....

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Real-world evidence (RWE) is used in an exponential way to guide payment decisions and access system.....

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Pulmonary Arterial Hypertension (PAH) is a rare, chronic, and progressive form of Pulmonary Hyperten.....

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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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