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Pharma News and Updates for AbbVie, Arrowhead Pharma, Novartis, FORE Biotherapeutics, Ellipses Pharma, Karuna Therapeutics
AbbVie Announces Results of Study Evaluating SKYRIZI; FDA Fast Track Designation to Arrowhead’s ARO-APOC3; FDA Approves Dabrafenib Plus Trametinib for BRAF V600E–Mutated Low-Grade Glioma; FDA Grants ODD to Novel BRAF Inhibitor for Brain/CNS Malignancies; EP0042 Wins FDA Orphan Drug Status; Karuna Therapeutics Announces Results from Phase 3 EMERGENT-3 Trial of KarXT in Schizophrenia

AbbVie Announces Positive Results of Study Evaluating SKYRIZI in Plaque Psoriasis Patients AbbVie announced new 52-week data from an open-label, a single-arm study demonstrating improved plaque psoriasis signs and symptoms in a difficult-to-treat patient population who received SKYRIZI® (risankizumab), an IL-23 ...

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MedTech News for Artica Systems, Nevro, Stratus® Medical, Restore Medical, Respiree, Abbott
Artica Systems’s Electric Whole-Body Cryotherapy Machines; Nevro’s Revolutionary HFX iQ™ Spinal Cord Stimulation System; COBRA Study of Stratus® Medical for Nimbus® Radiofrequency Ablation Device; Restore Medical’s CONTRABAND™ System; US FDA 510(k) Clearance for RS001 Cardio-respiratory Wearable; FDA Approval to Abbott’s Traumatic Brain Injury (TBI) Blood Test

New Commercial & Residential Electric Whole-Body Cryotherapy Machines Released by Artica Systems  On March 2, 2023, Artica Systems, an American company with over 20 years of experience in the wellness industry announced the release of a new and innovative 100% electric, whole-body cryotherapy fleet mean...

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Pharma News and Updates for Incyte, Eisai, Biogen, Reata Pharmaceuticals, Genenta Science, Harbour BioMed, Ikena Oncology
Incyte’s Clinical Trial for Myelofibrosis; Eisai and Bioge’s Leqembi; FDA Approves Reata Pharmaceuticals’ SKYCLARYS; Temferon Lands FDA Orphan Drug Status for Glioblastoma; Harbour BioMed Announces Results from Phase III Trial of Batoclimab; FDA Fast Track Designation to Ikena’s AHR Antagonist IK-175

Incyte Halts Phase III Clinical Trial for Myelofibrosis  Incyte announced the termination of Phase III LIMBER-304 trial after the results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC) revealed that the study is unlikely to meet the primary endpoint in the int...

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MedTech News and Updates for SOPHiA GENETICS, QIAGEN, Co-Diagnostics, Abbott, SpectraWAVE, Bioelectronic Medicine
Eko’s AI-powered Sensora Platform; SOPHiA GENETICS and QIAGEN Announced Partnership; Co-Diagnostics’s At-Home and Point-of-Care Co-Dx PCR Home™ Platform; Abbott’s Minimally Invasive Heart Devices Updates; SpectraWAVE’s HyperVue™ Intravascular Imaging System; FDA Approval to Bioelectronic Medicine’s Bioelectric Technology

AI-powered Sensora Platform Launched by Eko for Cardiac Disease Detection On February 23, 2023, Eko, a digital healthcare company employing artificial intelligence (AI) against heart and lung disease, announced the launch of its SENSORA™ Cardiac Disease Detection Platform. The stethoscope, one of the m...

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Pharma News and Updates for SpringWorks Therapeutics, AskBio, Mitsubishi Tanabe Pharma America, Sage Therapeutics, Biohaven Pharma
SpringWorks’s Desmoid Tumors Therapeutic, Nirogacestat; Orphan Drug Designation to AskBio’s AB-1003; Mitsubishi Tanabe’s Phase 3 Trial of RADICAVA ORS in ALS; EU Orphan Drug Designation to Sage Therapeutics’s SAGE-718; FDA Fast Track Status to Biohaven’s Taldefgrobep Alfa

Sage Therapeutics Receives EU Orphan Drug Designation for Huntington's Disease Treatment Candidate Sage Therapeutics declared the European Medicines Agency granted Orphan Drug Designation to SAGE-718 for the treatment of Huntington's disease. SAGE-718 is developing as a potential oral therapy for cognitive disor...

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MedTech News GI Dynamics, EndoStream Medical, Ibex, Sunrise
GI Dynamics’s I-STEP Clinical Study of EndoBarrier; EndoStream’s Clinical Trial for Nautilus™ Intrasaccular System; CE Mark for Ibex’s Galen™ Prostate; Sunrise’s At-home Sleep Apnea Test; Globus Medical Announced Merger with NuVasive; Boston Imaging’s HERA W10 Elite

First Patient Enrolled in I-STEP Clinical Study of EndoBarrier in India On February 13, 2023, GI Dynamics Inc., a medical device company, announced the enrollment of the first candidate in the I-STEP clinical trial in India. The trial aimed to assess the safety and effectiveness of the EndoBarrier® System for gl...

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MedTech News Updates LivaNova, Candela, 3M, Aspivix, Ethicon
LivaNova Launched SenTiva DUO; Candela Launched Matrix System; 3M Launched Medical Adhesive; MONARCH Platform Performed First Kidney Stones Removal Procedure; Biosense Webster Presented Data of HELIOSTAR Balloon Ablation Catheter; FDA 510(k) Clearance to Aspivix’s Cervical Stabilizer Carevix

LivaNova Launched SenTiva DUO, an Implantable Pulse Generator On February 3, 2023, LivaNova PLC, a market-leading medical technology and innovation company launched SenTiva DUO™, an implantable pulse generator (IPG) with a dual-pin header that delivers VNS Therapy™ for the treatment of drug-resista...

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Eli Lilly’s Jaypirca Approval; Novartis’ Adakveo EMA Review; Janssen’s CARTITUDE-4 Study of CARVYKTI; Negative Review on Ipsen’s Palovarotene; Gilead Sciences and Kite’s Yescarta NICE Recommendations; Daiichi Sankyo and AstraZeneca’s Enhertu EU Approval

FDA Approves Eli Lilly’s Jaypirca for Relapsed Mantle Cell Lymphoma Eli Lilly has received FDA approval for Jaypirca, a non-covalent BTK inhibitor, in relapsed mantle cell lymphoma (MCL) patients who have relapsed after treatment with other drugs in the class. Adult MCL patients who have previously received at l...

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Latest Pharma News and Updates for BeiGene, Seagen, Alnylam, Roche, Astellas
BeiGene’s Brukinsa Approval; FDA Approval to Seagen’s TUKYSA; NICE Recommends Alnylam’s Amvuttra; FDA Approves Brenzavvy for Type 2 Diabetes; Roche’s Tecentriq to be Filed for Early-stage Liver Cancer; FDA Lifts Hold on Astellas’ Pompe Gene Therapy

FDA Approves BeiGene’s Brukinsa for CLL/SLL BeiGene's Brukinsa (zanubrutinib) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) has been approved by the US Food and Drug Administration. CLL is a common type of leukemia, accounting for approximately 25% of all new cases each year. SLL is...

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MedTech News for Cardiovascular Systems, Koneksa, Medcura, Abbott, Enovis, Bausch + Lomb, AcuFocus
First Patient Enrolled in Kaizen Clinical Study in Japan; Koneksa’s At-Home Mobile Spirometry Clinical Trial; Medcura’s LifeGel™ Absorbable Surgical Hemostat; FDA Clearance to Abbott’s NAVITOR; Enovis’s DynaClip Delta™ and DynaClip Quattro™ bone staples; Bausch + Lomb Acquired AcuFocus

First Patient Enrolled in Kaizen Clinical Study in Japan  On January 11, 2023, Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional treatment systems for patients suffering from peripheral and coronary artery disease, announced the initiation of the...

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