PharmaShots Weekly Snapshots (Apr 26 – 30, 2021)

BMS Reports the US FDA’s Acceptance of Opdivo’s sBLA for Priority Review to Treat Muscle Invasive Urothelial Carcinoma

Published: Apr 30, 2021 | Tags: BMS, US, FDA, Opdivo, sBLA, Priority Review, nivolumab, Muscle Invasive Urothelial Carcinoma

Janssen Reports MAA Submission to EMA for Cilta-cel to Treat Relapsed/ Refractory Multiple Myeloma

Published: Apr 30, 2021 | Tags: Janssen, MAA, Submission, EMA, Cilta-cel, Relapsed/ Refractory, Multiple Myeloma

Repertoire Collaborates with Yale University to Identify Novel Antigen and T- Cell Receptor for Multiple Sclerosis

Published: Apr 30, 2021 | Tags: Repertoire, Yale University, Antigen, T- Cell Receptor, Multiple Sclerosis

Celltrion Reports Results of Regdanvimab (CT-P59) in Pre-Clinical Study Against the South African Variant (B.1.351)

Published: Apr 30, 2021 | Tags: Celltrion, Results, Regdanvimab, CT-P59, Pre-Clinical, Study, South African Variant, B.1.351

Innovent Reports First Patient Dosing in P-II Trial of IBI302 for Neovascular Age-Related Macular Degeneration

Published: Apr 30, 2021 | Tags: Innovent, First Patient, Dosing, P-II, Trial, IBI302, Neovascular Age-Related Macular Degeneration

Alphamab and Pfizer Initiate P-II Trial Evaluating KN046 + Inlyta (axitinib) as a 1L Treatment of Non-Small Cell Lung Cancer

Published: Apr 30, 2021 | Tags: Alphamab, Pfizer, Initiate, P-II, Trial, KN046, Inlyta, axitinib, Non-Small Cell Lung Cancer

Angion and Vifor Pharma Report Completion of Patient Enrollment in P-II AKI-002-15 Study of ANG-3777 for Cardiac-Surgery Associated Acute Kidney Injury

Published: Apr 29, 2021 | Tags: Angion, Vifor Pharma, Completion, Patient Enrollment, P-II, AKI-002-15 Study, ANG-3777, Cardiac-Surgery, Acute Kidney Injury

Alcon to Acquire Exclusive US Commercialization Rights to Novartis’ Simbrinza

Published: Apr 29, 2021 | Tags: Alcon, Exclusive, US, Commercialization Rights, Novartis, Simbrinza

BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III Head-to-Head APSEN Trial for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Published: Apr 29, 2021 | Tags: BeiGene, Results, Brukinsa (zanubrutinib), P-III, APSEN Trial, R/R Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

BioMarin Collaborates with Allen Institute to Develop Gene Therapies for Rare Brain Diseases

Published: Apr 29, 2021 | Tags: BioMarin, Allen Institute, Develop, Gene Therapies, Rare Brain Diseases

Organicell Reports the Expansion of its Trial for Zofin to Treat COVID-19 Patients in India

Published: Apr 29, 2021 | Tags: Organicell, Expansion, Trial, Zofin, Treat, COVID-19, India

Pfizer Acquires Amplyx to Expand its Infectious Disease Portfolio

Published: Apr 29, 2021 | Tags: Pfizer, Amplyx, Expand, Infectious Disease

Voluntis Collaborates with Eisai to Develop Digital Therapeutics for Oncology Patients

Published: Apr 28, 2021 | Tags: Voluntis, Eisai, Develop, Digital Therapeutics, Oncology

LogicBio Signs an Option Agreement with Canbridge to Develop Gene Editing Therapies

Published: Apr 28, 2021 | Tags: LogicBio, Option Agreement, Canbridge, Develop, Gene Editing Therapies

InveniAI Collaborates with Shionogi on AI-Based Drug Discovery

Published: Apr 28, 2021 | Tags: InveniAI, Shionogi, AI-Based, Drug Discovery

Y-mAbs Reports MAA Submission to EMA for Omburtamab to Treat Pediatric Patients with CNS/Leptomeningeal Metastasis from Neuroblastoma

Published: Apr 28, 2021 | Tags: Y-mAbs, MAA, Submission, EMA, Omburtamab,  CNS/Leptomeningeal Metastasis, Neuroblastoma

Abbott Launches AI-Powered Coronary Imaging Platform in Europe

Published: Apr 28, 2021 | Tags: Abbott, Launches, AI-Powered, Coronary Imaging Platform, Europe

The US FDA Grants Priority Review to Takeda’s Mobocertinib (TAK-788) for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

Published: Apr 28, 2021 | Tags: US, FDA, Priority Review, Takeda, Mobocertinib, TAK-788, EGFR Exon20 Insertion, Metastatic, Non-Small Cell Lung Cancer

Glenmark’s Ryaltris Nasal Spray Receives EC’s Approval as 1L Treatment for Allergic Rhinitis

Published: Apr 27, 2021 | Tags: Glenmark, Ryaltris Nasal Spray, EC, Approval, Treatment, Allergic Rhinitis

Daiichi Sankyo Expands its Collaboration with Esperion to Additional Territories

Published: Apr 27, 2021 | Tags: Daiichi Sankyo, Expands, Esperion, Additional, Territories

Pieris Out-licenses PRS-342 to Boston Pharmaceuticals for ~$363M

Published: Apr 27, 2021 | Tags: Pieris, Out-licenses, PRS-342, Boston Pharmaceuticals,  ~$363M

I-Mab Reports Results of Olamkicept (TJ301) in P-II Study for Ulcerative Colitis

Published: Apr 27, 2021 | Tags: I-Mab, Results, Olamkicept, TJ301, P-II Study, Ulcerative Colitis

Medtronic Collaborates with Surgical Theater to Provide Augmented Reality Platform to Neurosurgery

Published: Apr 27, 2021 | Tags: Medtronic, Surgical Theater, Augmented Reality Platform, Neurosurgery

Biocon Biologics and Viatris Receive European Commission Approval for Abevmy (biosimilar, bevacizumab)

Published: Apr 27, 2021 | Tags: Biocon Biologics, Viatris, European Commission, Approval, Abevmy

AstraZeneca’s Tagrisso (osimertinib) Receives EU’s CHMP Positive Opinion for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Published: Apr 26, 2021 | Tags: AstraZeneca, Tagrisso, osimertinib, EU, CHMP, Positive Opinion, Early-Stage, EGFR-Mutated Lung Cancer

AstraZeneca and MSD’s Selumetinib Receive EU’s CHMP Positive Opinion as the First Therapy for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas

Published: Apr 26, 2021 | Tags: AstraZeneca, MSD, Selumetinib, EU, CHMP, Positive Opinion, First Therapy, Neurofibromatosis Type 1 Plexiform Neurofibromas

Sanofi and AstraZeneca Report Results of Nirsevimab in P-III MELODY Study for the Protection of Healthy Infants Against Respiratory Syncytial Virus Disease

Published: Apr 26, 2021 | Tags: Sanofi, AstraZeneca, Results, Nirsevimab, P-III, MELODY Study, Respiratory Syncytial Virus Disease

Dermavant Presents Results of Tapinarof in Two P-III Trials for the Treatment of Psoriasis at AAD2021

Published: Apr 26, 2021 | Tags: Dermavant, Results, Tapinarof, Two, P-III, Trials, Psoriasis

GSK’s Jemperli (dostarlimab) Receives the EC’s Approval for Recurrent or Advanced dMMR/MSI-H Endometrial Cancer

Published: Apr 26, 2021 | Tags: GSK, Jemperli, dostarlimab, EC, Approval, Recurrent, Advanced, dMMR/MSI-H, Endometrial Cancer

BMS Presents Results of Deucravacitinib in Two P- III Trials for Moderate to Severe Plaque Psoriasis at AAD2021

Published: Apr 26, 2021 | Tags: BMS, Results, Deucravacitinib, Two, P- III Trials, Moderate, Severe, Plaque Psoriasis

Related Post: PharmaShots Weekly Snapshots (Apr 19 – 23, 2021)

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