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)
