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PharmaShots Weekly Snapshots (July 11 – 15, 2022)

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PharmaShots Weekly Snapshots (July 11 – 15, 2022)

PharmaShots Weekly Snapshots (July 11 – 15, 2022)

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

Related Post: PharmaShots Weekly Snapshots (July 04 – 08, 2022)


Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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