Polpharma Biologics Report EMA's Acceptance of MAA for Biosimilar Natalizumab, a Proposed Biosimilar to Tysabr for Relapsing-Remitting Multiple Sclerosis

Published: July 15, 2022 | Tags: Polpharma Biologics, Biosimilar, Natalizumab, Tysabr, Relapsing-Remitting Multiple Sclerosi, EMA, MAA

BMS' Opdivo (nivolumab) + Yervoy (ipilimumab) Receives NICE Recommendation as 1L Treatment of Malignant Pleural Mesothelioma

Published: July 15, 2022 | Tags: BMS, NICE, Opdivo, nivolumab, Yervoy, ipilimumab, Malignant Pleural Mesothelioma, Regulatory

Grünenthal Entered into an Agreement with Bayer to Acquire Nebido for Male Hypogonadism Associated with Testosterone Deficiency

Published: July 15, 2022 | Tags: Grünenthal, Bayer, Nebido, Male Hypogonadism, Testosterone Deficiency, Pharma

Royalty Pharma to Acquire Royalty Rights from Theravance and Innoviva for ~$1.5B

Published: July 15, 2022 | Tags: Royalty Pharma, Theravance, Innoviva, Trelegy Ellipta, ampreloxetine, Chronic Obstructive Pulmonary Disease, Symptomatic Neurogenic Orthostatic Hypotension, Acquire ~$1.5B

Genentech Presents Two-Year Data of Vabysmo in P-III (TENAYA) and (LUCERNE) Studies for Wet Age-Related Macular Degeneration at ASRS 2022

Published: July 15, 2022 | Tags: Genentech, Vabysmo, Wet Age-Related Macular Degeneration, Clinical Trial, P-III TENAYA, LUCERNE Studies, ASRS, 2022

SK Biopharmaceuticals Entered into a License Agreement with Eurofarma to Develop and Commercialize Cenobamate for Epilepsy in Latin America

Published: July 15, 2022 | Tags: SK Biopharmaceuticals, Eurofarma, Cenobamate, Epilepsy, Pharma, Latin America

NICE Publishes Final Recommendation for Novartis’ Piqray and Gilead’s Trodelvy to Treat Breast Cancer

Published: July 14, 2022 | Tags: NICE, Novartis, Gilead, Piqray, Trodelvy, Breast Cancer

Anumana Entered into a Multi-Year Strategic Collaboration with Novartis to Develop ECG AI Algorithms for the Detection of Heart Disease

Published: July 14, 2022 | Tags: Anumana, Novartis, ECG AI Algorithms, Heart Disease, MedTech

Orthofix Medical Signs a License Agreement with LimaCorporate to Provide Novel Solution for High Hip Dislocation in the US

Published: July 14, 2022 | Tags: Orthofix Medical, LimaCorporate, High Hip Dislocation, Pharma, US, ProMade 3D-Printed Custom Service

Regeneron & Sanofi Report P-III Trial Results of Dupixent (dupilumab) for Eosinophilic Esophagitis in Children Aged 1 to 11 Years

Published: July 14, 2022 | Tags: Regeneron, Sanofi, Dupixent, dupilumab, Eosinophilic Esophagitis, Clinical Trials, P-III Trial

NICE Issues Final Guidance on Amarin’s Vazkepa (icosapent ethyl) for the Treatment of Cardiovascular Disease

Published: July 14, 2022 | Tags: Amarin, Vazkepa, icosapent ethyl, Cardiovascular Disease, Regulatory, NICE, Reimbursement, NHS

Novavax’s NVX-CoV2373 Receive the US FDA’s EUA for COVID-19 in Patients Aged ≥18 Years

Published: July 14, 2022 | Tags: Novavax, NVX-CoV2373, COVID-19, Regulatory, US, FDA, EUA

Labcorp Launched Neurofilament Light Chain Blood Test to Identify Neurodegenerative Disease

Published: July 13, 2022 | Tags: Labcorp, Neurofilament Light Chain Blood Test, Neurodegenerative Disease, MedTech

Orion Entered into a Research Collaboration with Peptilogics to Enable AI-Driven Drug Discovery Against Undrugged GPCR Target

Published: July 13, 2022 | Tags: Orion, Peptilogics, AI-Driven, Pharma, GPCR Target, Nautilus AI-driven peptide design platform, GPCR platform

NeoImmuneTech’s NT-I7 (efineptakin alfa) Receives the US FDA Orphan Drug Designation for the Treatment of Glioblastoma Multiforme

Published: July 13, 2022 | Tags: NeoImmuneTech, NT-I7, efineptakin alfa, Glioblastoma Multiforme, Regulatory, US, FDA, Orphan Drug Designation

Abbott’s Deep Brain Stimulation System Receives the US FDA's Breakthrough Device Designation for Severe Depression

Published: July 13, 2022 | Tags: Abbott, Deep Brain Stimulation System, Severe Depression, Regulatory, US, FDA, Breakthrough Device Designation

HUTCHMED Presents P-II (SAVANNAH) Trial Results of Savolitinib + Tagrisso (osimertinib) for EGFR-Mutated NSCLC at WCLC 2022

Published: July 13, 2022 | Tags: HUTCHMED, Savolitinib, Tagrisso, Osimertinib, EGFR-Mutated, NSCLC, Clinical Trial, P-II, SAVANNAH Trial, WCLC, 2022

Medtronic to Acquire CathWorks for ~$585M and Entered into a Co-Promotion for FFRangio System

Published: July 13, 2022 | Tags: Medtronic, CathWorks , FFRangio System, Coronary Artery Disease,  Acquire, ~$585M

Aurora Spine Receives the US FDA’s Clearance for ZIP MIS Implant Device to Treat Lumbar Spinal Stenosis

Published: July 12, 2022 | Tags: Aurora Spine, ZIP MIS Implant Device, Lumbar Spinal Stenosis, Regulatory, US, FDA

LegoChem Entered into a Research Collaboration and License Agreement with Glycotope to Develop ADCs for the Treatment of Cancer

Published: July 12, 2022 | Tags: LegoChem, Glycotope, ADCs, Cancer, Biotech

Arcutis Reports the Health Canada Acceptance of New Drug Submission for Review of Roflumilast to Treat Plaque Psoriasis

Published: July 12, 2022 | Tags: Arcutis, Roflumilast, Plaque Psoriasis, Regulatory, Health Canada, New Drug Submission

Roche Presents P-III (HAVEN 6) Study Results of Hemlibra (emicizumab) for Moderate or Mild Haemophilia A at ISTH 2022

Published: July 12, 2022 | Tags: Roche, Hemlibra, emicizumab, Haemophilia A, Clinical Trial, P-III, HAVEN 6 Study, ISTH 2022

Innoviva to Acquire La Jolla for ~$149M

Published: July 12, 2022 | Tags: Innoviva, Giapreza, Xerava, blood pressure, abdominal infections, M&A, Acquire, La Jolla, ~$149M

Vertex to Acquire ViaCyte for ~$320M and Deliver Stem Cell-Derived Cell Replacement Therapies for Type 1 Diabetes

Published: July 12, 2022 | Tags: Vertex, ViaCyte, Stem Cell-Derived, Cell Replacement Therapies, VX-880, M&A, Acquire

Novo Nordisk Presents Results of Concizumab in P-III (explorer7) Study for the Treatment of Haemophilia A or B at ISTH 2022

Published: July 11, 2022 | Tags: Novo Nordisk, Concizumab, Haemophilia A or B, Clinical Trial, P-III, explorer7 Study, ISTH 2022

Anthos’ Abelacimab Receives the US FDA’s Fast Track Designation for the Treatment of Thrombosis Associated with Cancer

Published: July 11, 2022 | Tags: Anthos, Abelacimab, Thrombosis, Cancer, Regulatory, US, FDA, Fast Track Designation

Telix Reports the Completion of Patient Enrollment in P-III (ZIRCON) Study of TLX250-CDx for the Treatment of Clear Cell Renal Cell Cancer

Published: July 11, 2022 | Tags: Telix, TLX250-CDx, Clear Cell Renal Cell Cancer, Clinical Trial, P-III, ZIRCON Study

Sanofi and Sobi Report Results of Efanesoctocog Alfa (BIVV001) in P-III (XTEND-1) Study for the Treatment of Severe Hemophilia A

Published: July 11, 2022 | Tags: Sanofi, Sobi, Efanesoctocog Alfa, BIVV001, Severe Hemophilia A, P-III, XTEND-1 Study

Horizon’s Krystexxa (pegloticase) Receives the US FDA’s Approval and Expanding the Labeling for the Treatment of Uncontrolled Gout

Published: July 11, 2022 | Tags: Horizon, Krystexxa, pegloticase, Uncontrolled Gout, US, FDA,

Sanofi Reports Results of Fitusiran in P-III (ATLAS-PPX) Study for the Treatment of Hemophilia A or B

Published: July 11, 2022 | Tags: Sanofi, Fitusiran, Hemophilia A or B, P-III, ATLAS-PPX Study

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