Oncology Highlights – 30/07/2018

Notizia - Recent Pharma, Healthcare and Biotech Happenings

Olympus’s Next Generation Electrosurgical Gener...

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...

Jun 08, 2023

Pharma News for Pfizer, Daiichi Sankyo, Kyverna, Servier
Daiichi Sankyo’s Intravenous Iron Replacement Therapy; ANeuroTech’s Adjunctive Anti-depression Drug, ANT-01; Kyverna Therapeutics’s KYV-101 in Lupus Nephritis; Servier Presents Data from Phase 3 INDIGO Trial of Vorasidenib; FDA Approves Pfizer’s ABRYSVO

FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults Pfizer Inc. announced that the FDA has authorized ABRYSVO (Respiratory Syncytial Virus Vaccine), the company's bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory...

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MedTech News for Cepheid, Anika, EMVision
THINK Surgical’s TMINI Miniature Robotic System; Cepheid’s Xpert NPM1 Mutation Test; Anika’s Hyalofast® US Pivotal Phase III Study; EMVision’s Portable Brain Scanner Trial; HeartBeam and Samsung’s Strategic Alliance Agreement; Eosolutions’s Dr. Banner Balloon Guide Catheter

TMINI Miniature Robotic System by THINK Surgical Received FDA 510(k) Clearance On May 30, 2023, THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TMINI™ Miniature Robotic System. A wireless r...

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Pharma News for Lexicon, Novartis, Takeda and HUTCHMED
FDA Approves Lexicon’s INPEFA (Sotagliflozin); PTC Therapeutics’s Vatiquinone MOVE-FA Registration-Directed Trial; EU Approval to Novartis’s Sickle Cell Disease Drug; EMA Approves Neoadjuvant Nivolumab/Chemotherapy in Resectable NSCLC; FDA Grants Priority Review to Fruquintinib for mCRC; FDA Orphan Drug Designation to Vega Therapeutics’s VGA039

Lexicon Announces FDA Approval of INPEFA (Sotagliflozin) For Treatment of Heart Failure Lexicon Pharmaceuticals, Inc. announced that the FDA has approved INPEFATM (sotagliflozin), a once-daily oral tablet, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure vis...

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MedTech News for Eosolutions, Grünenthal, Orlucent
Eosolutions Corp’s Dr. Banner Balloon Guide Catheter; US FDA Approves the Cyltezo® Pen; Orlucent’s Handheld Mole Imaging System; Grünenthal’s Resiniferatoxin for Pain Associated with Knee Osteoarthritis; Element Science’s Jewel Patch Wearable Cardioverter Defibrillator; A.Menarini Diagnostics’s PRIME MDx Platform

Eosolutions Announces The Full Commercial Launch of The Dr. Banner Balloon Guide Catheter EOSolutions Corp., a forerunner in medical technology focused on offering high-quality catheter solutions, is pleased to introduce the Dr. Banner, Balloon Guide Catheter (BGC). Dr. Banner, developed in collaboration with In...

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Pharma News for AbbVie, Oculis, AstraZeneca, Krystal Biotech, Alligator Biosciences
FDA Approves RINVOQ for Crohn’s Disease; FDA Approves Krystal Biotech’s Gene Therapy Vyjuvek; FDA Approves EPKINLY to Treat R/R DLBCL; FDA Orphan Drug Designation to Mitazalimab; Phase 3 Trial Result of OCS-01 Eye Drops; TAGRISSO® + Chemotherapy for the EGFR-mutated Advanced Lung Cancer

FDA Approves RINVOQ as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease AbbVie announced that the FDA had approved RINVOQ® (upadacitinib) for treating people with moderately to highly active Crohn's disease who have had an unsatisfactory response or intolerance to one or more TNF blockers. Thi...

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MedTech News for Abbott, Regen Lab, Beckman Coulter, Shockwave Medical, Providence Medical Technology, ONWARD Medical N.V
FDA Approves Abbott’s Spinal Cord Stimulation Systems; Regen Lab Received CE Certification for Three PRP Solutions; Beckman Coulter Launched New Immunoassay Analyser; Shockwave Medical’s Coronary IVL Catheter; Providence Completed Enrollment in the FUSE Clinical Study; Onward Completed First-In-Human Use of Movement-Restoring Lead

Providence Medical Technology Completed Enrolment in the FUSE Clinical Study for High-Risk Cervical Fusion Patients  On May 11, 2023, Providence Medical Technology, Inc. (PMT), a leader in medical device innovation for spine surgery, closed the enrolment in its FUSE Study which is a prospective, multicenter...

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Pharma News and Updates for Sarepta, Astellas, SiSaf, ImmPACT Bio, Otsuka, CytoAgents, Lundbeck
Sarepta Therapeutics’s SRP-9001 Gene Therapy; FDA Approves Astellas’ VEOZAH; FDA Orphan Drug Designation and Rare Pediatric Disease Designation to SiSaf’s siRNA Therapy SIS-101-ADO; FDA Grants Fast Track Designation to IMPT-314; FDA Approves First Drug for Agitation in People With Alzheimer’s Disease; FDA Accepted the CytoAgents’ IND Application for CTO1681

Sarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy Sarepta Therapeutics, Inc., a pioneer in precision genetic medicine for rare diseases, announced that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in favor of...

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Norlase, HAPPE Spine, Soterix Medical, Akura Medical, Intelivation Technologies, Signifier Medical Technologies
Norlase’s ECHO™ Green Pattern Laser; HAPPE Spine’sINTEGRATE-C™ Interbody Fusion System; Soterix Medical’s Parcel-Guided rTMS Depression Trial; Akura Medical’s High-Performance Mechanical Thrombectomy Platform; Intelivation Technologies’s Golden Isles™ Minimally Invasive Pedicle Screw System; Signifier Medical Technologies Announced Partnership with Sunrise

Norlase Received FDA 510(k) Clearance and CE Mark Approval For ECHO™ Green Pattern Laser On May 5, 2023, Norlase, a leading global ophthalmic laser manufacturer developing next-generation laser solutions, received both 510(k) US Food and Drug Administration clearance and CE Mark approval for the ECHO Gree...

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Pharma News and Updates for GSK, Gilead, ProMIS, Nucleix, PharmaTher, Vedanta Biosciences
FDA Approves GSK’s Arexvy for RSV; CHMP’s Opinion on Gilead’s Hepcludex® for HDV; FDA Clearance to ProMIS’s IND Application for PMN310; FDA Grants 501K Clearance to Bladder EpiCheck; PharmaTher Submits Fast Track Application for Ketarx to US FDA; Fast Track Designation to Vedanta Biosciences’ VE303

FDA Approves GSK’s Arexvy, the First RSV Vaccine for Older Adults GSK plc stated that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by a respiratory syncytial virus (RSV) in peopl...

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

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The pharma industry has played a crucial role in fighting against the pandemic situation by supplyin.....

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Progressive Supranuclear Palsy (PSP) is a rare progressive disorder resulting from damage that occur.....

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

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End-Stage Renal Disease (ESRD) occurs when chronic kidney disease (CKD) has reached the stage where .....

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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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