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Pharma News for Exelixis, AstraZeneca, Kyverna
BMS, and Exelixis’s Opdivo + CABOMETYX in First-Line Advanced Renal Cell Carcinoma; AIRSUPRA Now Available as the First and Only FDA-approved Anti-inflammatory Rescue Option for Asthma; AstraZeneca’s Voydeya Receives First-ever Regulatory Approval; EMA Grants ODD to GC Biopharma’s Sanfilippo Syndrome (Type A) Treatment; FDA Approves NRx Pharma’s IND Application of NRX-101; FDA Fast Track Designation to Kyverna’s KYV-101

Opdivo in Combination with CABOMETYX Demonstrates Long-Term Survival Benefits After Four Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma Bristol Myers Squibb and Exelixis, Inc. have released the four-year follow-up findings from the CheckMate -9ER trial, which investiga...

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A Glance at Key Insights From 42nd J.P. Morgan Annual Healthcare Conclave

From January 8th to 11th, 2024, the 42nd Annual J.P. Morgan Healthcare Conference (JPM24) took center stage in San Francisco, CA, USA. Spanning four dynamic days, this conference saw the active participation of prominent figures from major pharmaceutical, biotechnology, Medtech, HealthTech entities, and emerging fa...

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Pharma News for AskBio, Merck, SELLAS, RemeGen
Bayer’s AskBio Initiates Phase II GenePHIT Trial; FDA Approves Merck’s KEYTRUDA Plus Chemoradiotherapy as Treatment for Stage III-IVA Cervical Cancer; FDA Fast Track Designation to SELLAS Life Sciences R/R AML; RemeGen’s RC88; Shorla Oncology Announces FDA Filing Acceptance of New Drug Application for Novel Formulation to Treat Breast and Ovarian Cancer; Tonix Pharma’s TNX-102 SL for Fibromyalgia

Bayer’s AskBio initiates Phase II GenePHIT trial in Congestive Heart Failure Merck, also recognized as MSD in regions beyond the United States and Canada, has officially announced that the FDA has approved for the use of KEYTRUDA, Merck's anti-PD-1 therapy, in conjunction with chemoradiotherapy (CRT) for treatin...

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MedTech News for Medtronic, Cala, Medline, Rivermark Medical
Medtronic Announced World’s First Approval for MiniMed 780G System; CE Mark for Medtronic’s Next Generation Micra Leadless Pacing Systems; Biosense Webster Received Approval for VARIPULSE PFA Platform; Rivermark Medical Updated on Flostent System; Cala Disclosed TAPS Therapy Data for Essential Tremor; Medline Introduced Transparent Wound Dressing

Medtronic Received CE Mark for its Next Generation Micra Leadless Pacing Systems On January 5, 2024, Medtronic announced that the Micra AV2 and Micra VR2, the next generation of its industry-leading tiny, leadless pacemakers, earned the CE (Conformité Européenne) Mark. The world's tiniest pacemakers, the rMic...

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Pharma News for Merck, AbbVie, Abbisko
Merck to Acquire Harpoon Therapeutics; Novo Nordisk Enters Into Collaborations with Omega Therapeutics and Cellarity; AbbVie’s Lutikizumab’s Phase II Trial Result for Hidradenitis Suppurativa; Abbisko’s CSF-1R Inhibitor Pimicotinib (ABSK021); Cabaletta Bio’s CABA-201; FDA Grants Fast Track” Designation for Soligenix’s Dusquetide

Lutikizumab Showed Positive Results in a Phase II Trial of Adults with Moderate to Severe Hidradenitis Suppurativa as Program Advances to Phase III AbbVie has reported the results of Phase II trials indicating that adults experiencing moderate to severe hidradenitis suppurativa, and who had previously not respon...

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Pharma News for Cytokinetics, Chiesi, AstraZeneca, Zevra
Cytokinetics Announces Results From SEQUOIA-HCM Clinical Trial of Aficamten; FDA Approves Chiesi’s FILSUVEZ Topical Gel; Bristol Myers Squibb Adds Premier Radiopharmaceutical Platform; AstraZeneca to Acquire Gracell; Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application; Innovent Dosed First Participant in Phase 3 Clinical Study (GLORY-2) of Mazdutide (IBI362)

Cytokinetics Announces Positive Results From SEQUOIA-HCM, the Pivotal Phase III Clinical Trial of Aficamten in Patients With Obstructive Hypertrophic Cardiomyopathy Cytokinetics, Incorporated released favorable top-line findings from the SEQUOIA-HCM trial (Safety, Efficacy, and Quantitative Understanding of Obst...

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Pharma News for Amylyx, Sellas, Apnimed, Ocelot
ImPact Biotech’s IND Application for Padeliporfin VTP; Orphan Drug Designation to Ocelot Bio’s OCE-205 for Ascites; Amylyx’s Phase 3 ORION Study of AMX0035 for PSP; SELLAS Receives FDA Orphan Drug Designation for SLS009 for PTCL Treatment; Apnimed Updated on Second Phase 3 Clinical Study of AD109 for OSA

ImPact Biotech Receives FDA Clearance of IND Application for Padeliporfin VTP in Pancreatic Cancer ImPact Biotech, a biotechnology company in its clinical stage dedicated to advancing Padeliporfin Vascular Targeted Photodynamic (VTP) therapy for various solid tumors, announced on December 20, 2023, that the U.S....

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Pharma News for Eisai, Biogen, Merck, BMS, Kyverna
Eisai Submits Marketing Authorization Application for Tasurgratinib; CHMP Issues Positive Opinion for Biogen’s SKYCLARYS; European Commission Approves Merck’s KEYTRUDA + Chemotherapy HER2-ve Gastric or GEJ Adenocarcinoma; BMS Provides Update on RELATIVITY-123 Trial; Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101; Verrica and Torii Pharma Announces Positive Top-line Results from a Confirmatory Phase 3 Trial of TO-208

Eisai Submits Marketing Authorization Application In Japan for Anticancer Agent Tasurgratinib For Biliary Tract Cancer With FGFR2 Gene Fusion Eisai Co., Ltd. has officially submitted a request for marketing authorization in Japan for tasurgratinib succinate, its internally developed tyrosine kinase inhibitor tar...

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Pharma News for Merck, Ipsen, bluebird bio
Merck and Moderna Initiate Study to Evaluate V940; FDA Approves Vertex and CRISPR Therapeutics’ CASGEVY for SCD; Novartis Updated on its Investigational Iptacopan Phase III Study; FDA Grants Priority Review for New Drug Application for Elafibranor; FDA Approves bluebird bio’s LYFGENIA for Patients SCD; FDA Fast Track Designation for DMD Gene Therapy

Merck and Moderna Initiate INTerpath-002, a Phase III Study Evaluating V940 in Combination with KEYTRUDA for Adjuvant Treatment of Patients with Certain Types of Resected NSCLC Merck (also known as MSD outside the United States and Canada) and Moderna, Inc. have commenced the INTerpath-002 trial—a crucial Phase ...

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MedTech News for Laminar, BD, Vivos, Zilia, Penumbra
Johnson & Johnson Medtech Acquired Laminar; BD Launched Advanced Vascular Access Ultrasound System; FDA Cleared Oral Device for Severe Sleep Apnea; FDA Clearanced the Zilia OcularTM FC Retinal Camera; First Patient Enrolled in Penumbra Study of Computer-assisted Vacuum Thrombectomy; US FDA Granted the BiVACOR Total Artificial Heart IDE Approval for First-in-Human Early Feasibility Study

FDA Cleared Oral Device for Severe Sleep Apnea From Vivos Therapeutics On November 29, 2023, Vivos Therapeutics announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Vivos’s removable CARE (Complete Airway Repositioning and Expansion) oral appliances developed for treat...

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