Oncology Highlights – 30/07/2018

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Quest Introduced Consumer-Initiated Blood Test ...

Quest Introduced First-To-Market Consumer-Initiated Blood Test for Alzheimer's Disease Risk Assessment on Questhealth Website On July 31, 2023, Quest Diagnostics, a leader in diagnostic information...

Aug 10, 2023

Pharma News for Biogen, Astellas, Ascentage
FDA Approves ZURZUVAE for Postpartum Depression; Astellas Drug Acquired in $5.9B Deal Wins FDA Approval; FDA Clearance to Phase III Study of Lisaftoclax; FDA Issues CRL to BLA Resubmission for Remestemcel-L; Bavarian Nordic Updated on its Chikungunya Virus Vaccine; FDA Orphan Drug Designation to ABM-1310

FDA Approves ZURZUVAE, the First and Only Oral Treatment Approved for Women with Postpartum Depression Biogen Inc. and Sage Therapeutics, Inc. announced that the FDA has approved ZURZUVAE (zuranolone) 50 mg for individuals with postpartum depression (PPD). ZURZUVAE is the first and only 14-day oral, once-daily t...

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MedTech News for icotec, Terumo, Genesis
Icotec’s VADER Pedicle System; Terumo BCT’ Reveos Automated Whole Blood Processing System; Genesis MedTech’s J-Valve Transfemoral System; STARmed Launched STARmed America in the USA

Genesis MedTech Announces FDA Breakthrough Device Designation for the J-Valve™ Transfemoral System Genesis MedTech, a leading medical device company, announced that the US Food and Drug Administration (FDA) has designated its J-ValveTM Transfemoral (TF) System as a Breakthrough Device. This innovative heart valv...

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Pharma News for GSK, Biogen, Citius
FDA Expands GSK’s Jemperli Approval; Biogen to Acquire Reata Pharma; Enhertu Shows Survival Boost in HER2+ Solid Tumors; FDA Rejects Citius’ Revived IL-2 Therapy; FDA Fast Track designation to IVS-3001 for RCC; EU Orphan Drug Designation to Biohaven’s Taldefgrobep Alfa

FDA Expands GSK’s Jemperli Approval for Endometrial Cancer GSK plc announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with mismatch repair deficient...

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More Views & Analysis

MedTech News VARON, Biostrap, MediView XR, Magnus
VARON’s New VP Series Portable Oxygen Concentrator; Biostrap’s Wrist-Worn Digital Health Monitoring Device; MediView’s AR Navigation Platform; Beckman Coulter’s DxC 500 AU Chemistry Analyzer; Magnus Updated on Study Using SAINT Neuromodulation System; Francis Medical’s VAPOR 2 Pivotal Study

VARON Launched the Game-changer in the Field--New VP Series Portable Oxygen Concentrator On July 19, 2023, VARON, a leading oxygen concentrator manufacturer, announced the launch of a game-changer portable oxygen concentrator VP-2.  A new member of the VP series, VP-2 is incorporated with innovative tech...

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Pharma News for Gilead, Ambrx, Mirati
Gilead’s Magrolimab Plus Azacitidine for MDS; FDA Approveds VANFLYTA for Newly Diagnosed AML; FDA Awards Fast Track Designation to ARX517 mCRPC; EMA Rejects Mirati’s Krazati; Harmony Phase III Pitolisant Trial for PWS Patients; Belite Bio’s Phase 3 DRAGON Trial of Tinlarebant for STGD

Gilead To Discontinue Phase III ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS Gilead Sciences, Inc. reported that the Phase III ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been halted due to futility based on a planned analysis. The safety data in this trial are consistent ...

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MedTech News for Relievant, EarliTec, ReddyPort
Relievant Medsystems Launched Ablation System; Thermo Fisher’s Reproductive Health Assays; EarliTec’s Next-Generation EarliPoint Evaluation for ASD; FDA Cleared ReddyPort® Non-Invasive Ventilation Device; EndoTheia’s Novel Medical Device for Endoscopic Surgery; Neurolief’s MOOD Trial Interim Analysis

Relievant Medsystems Launched New Tools for its Ablation System On June 14, 2023, Relievant Medsystems announced that it launched its next-generation access instruments for the Intracept procedure. Chronic vertebrogenic low back pain is treated with Intracept, a minimally invasive, same-day, outpatient proced...

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Pharma News for Eli Lilly, Alnylam, Elevar
Lilly to Acquire Versanis; FDA Approves Beyfortus for RSV in Infants; Alnylam Presented Updates on Interim Phase 1 Results for ALN-APP; FDA Accepts NDA for Rivoceranib Plus Camrelizumab; FDA Fast Track Designation to Karyopharm’s Selinexor; Adcentrx’s IND Application for ADRX-0706

Lilly to Acquire Versanis to Improve Patient Outcomes in Cardiometabolic Diseases Eli Lilly & Company and Versanis Bio announced a definitive agreement for Lilly to acquire Versanis, a private clinical-stage biopharmaceutical firm focused on the discovery of novel medications for the treatment of cardiometab...

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MedTech News for ResMed, Stryker, OncoBeta
ResMed Acquired Somnoware; Stryker Launched Q Guidance System; AlloSource’s AceConnex Pre-Sutured Fascia; Urotronic’s Optilume BPH Catheter System; Verve Medical’s Pivotal Trial of RPD Renal Pelvic Denervation System; OncoBeta Provided Update on Rhenium-SCT

ResMed Acquired Somnoware, a Leader in Digital Sleep and Respiratory Care Diagnostics Software On July 05, 2023, ResMed acquired privately held Somnoware, a US leader in sleep and respiratory care diagnostics software.  The Somnoware software streamlines the processes of physicians as well as sleep and p...

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Pharma News Astellas, Eisai, Iovance, Biophytis
FDA Grants Priority Review for Zolbetuximab BLA; FDA Traditional Approval for LEQEMBI for Alzheimer’s Disease; Iovance Announces Regulatory and Clinical Updates for TIL Therapy in Advanced NSCLC; Biophytis Seeks FDA Approval to Launch Phase 3 Study of Potential Treatment of Sarcopenia; Orphan Drug Designation to Marker Therapeutics’s MT-401 for AML Treatment; Axsome Therapeutics Initiates Phase 3 Trial of Solriamfetol for ADHD

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 Biologics Licence Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-target...

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Lamellar Ichthyosis (LI) is an autosomal recessive congenital Ichthyosis (ARCI), which mainly affect.....

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The Union of the European countries, also known as the European Union or the EU, is more or less lik.....

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The medical device (MedTech) industry has small and big companies operating in various segments such.....

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

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AAV Vectors are the leading viral vectors for gene delivery to treat a variety of human diseases. Ad.....

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The first biosimilar was made available to patients in the United States six years ago in 2021. Thes.....

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