PharmaShots Weekly Snapshots (May 22 - 26, 2023)
Date: May 26, 2023 | Tags: Takeda, HUTCHMED, Fruquintinib, Metastatic Colorectal Cancer, Regulatory, Priority Review, US, FDA
Gilead Receives EMA’s CHMP Positive Opinion to Extend the Use of Veklury (remdesivir) for COVID-19
Date: May 26, 2023 | Tags: Gilead, Veklury, remdesivir, COVID-19, P-I, GS-US-540-9015 PK study, REDPINE, Clinical Trial
Date: May 26, 2023 | Tags: Akebia, Medice Arzneimittel Pütter GmbH&Co.KG, Vafseo, Anemia, CKD, Pharma
Date: May 26, 2023 | Tags: Daiichi Sankyo, Vanflyta, quizartinib, FLT3-ITD Positive AML, Regulatory, MHLW, Approval
Date: May 26, 2023 | Tags: Merck, Eisai, Keytruda, Lenvima, Advanced Renal Cell Carcinoma, Clinical Trial, P-III, CLEAR Study, ASCO, 2023
Date: May 26, 2023 | Tags: Regeneron, Linvoseltamab, Multiple Myeloma, (LINKER-MM1) trial, Clinical Trial, ASCO, 2023
Sandoz Reports the EMA Acceptance of MAA for Proposed Biosimilar Denosumab
Date: May 25, 2023 | Tags: Sandoz, Denosumab, Biosimilar, Regulatory, Biosimilar, osteoporosis, EMA, MAA
Date: May 25, 2023 | Tags: Oxford BioTherapeutics, Boehringer Ingelheim, Cancer Immunotherapies, OGAP discovery platform, Biotech
Abbott Reports (MONITOR-HF) Trial Results of CardioMEMS Sensor for the Treatment of Heart Failure
Date: May 25, 2023 | Tags: Abbott, CardioMEMS Sensor, Heart Failure, Clinical Trial, MONITOR-HF Trial, DigiHealth
ClearPoint Neuro Entered into a Multi-Year License Agreement with UCB for Gene Therapy Drug Delivery
Date: May 25, 2023 | Tags: ClearPoint Neuro, UCB, Gene Therapy, ClearPoint Neuro Navigation System, Biotech
Date: May 25, 2023 | Tags: Immutep, eftilagimod alpha, Non-Small Cell Lung Cancer, Clinical Trial, P-I, INSIGHT-003 Trial
Celltrion’s Yuflyma (biosimilar, adalimumab) Receives the US FDA’s Approval for Multiple Indications
Date: May 25, 2023 | Tags: Celltrion, Yuflyma, biosimilar, adalimumab, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa, US, FDA, Approval, Regulatory, Biosimilar
Date: May 24, 2023 | Tags: Novo Nordisk, Life Edit Therapeutics, Gene Editing Therapies, rare genetic disorders, Cardiometabolic Diseases, Biotech
Date: May 24, 2023 | Tags: Alvotech, Advanz Pharma, Simponi, Entyvio, AVT23, Xolair, omalizumab, EU, Pharma, Biosimilar
Date: May 24, 2023 | Tags: CohBar, Morphogenesis, Late-Stage, Oncology, IFx-Hu2.0, M&A
Date: May 24, 2023 | Tags: Galapagos, GLPG3667, Dermatomyositis, Clinical Trial, P-II, GALARISSO Study
REGENXBIO’s RGX-121 Receives the US FDA’s RMAT Designation for the Treatment of Hunter Syndrome
Date: May 24, 2023 | Tags: REGENXBIO, RGX-121, Hunter Syndrome, Regulatory, US, FDA, RMAT Designation
Date: May 24, 2023 | Tags: Blueprint Medicines, Ayvakit, avapritinib, Indolent Systemic Mastocytosis, Clinical Trial, PIONEER Trial
Date: May 23, 2023 | Tags: Junshi Biosciences, Toripalimab, Triple-Negative Breast Cancer, Regulatory, NMPA, sNDA
Ironwood to Acquire VectivBio for ~$1B
Date: May 23, 2023 | Tags: Ironwood, VectivBio, apraglutide, Short Bowel Syndrome, Intestinal Failure, ~$1B, Acquire, M&A
Date: May 23, 2023 | Tags: Akebia, Vafseo, Symptomatic Anemia, Chronic Kidney Disease, Regulatory
BMS Reports P-II Study Results of BMS-986278 for the Treatment of Idiopathic Pulmonary Fibrosis
Date: May 23, 2023 | Tags: BMS, BMS-986278, Idiopathic Pulmonary Fibrosis, Clinical Trial, P-II Study
Date: May 23, 2023 | Tags: Blueprint Medicine, Ayvakit, avapritinib, Indolent Systemic Mastocytosis, Regulatory, US, FDA, Approval
Date: May 23, 2023 | Tags: Novo Nordisk, Semaglutide, Obesity, Overweight, Clinical Trial, P-IIIa, OASIS 1 Trial
Date: May 22, 2023 | Tags: BioArctic, Eisai, Lecanemab, Early Alzheimer's Disease, Regulatory, MAA, MHRA
Date: May 22, 2023 | Tags: Krystal Biotech, Vyjuvek, beremagene geperpavec, Dystrophic Epidermolysis Bullosa, Regulatory, US, FDA, Approval
Date: May 22, 2023 | Tags: Alnylam, Patisiran, ATTR Amyloidosis, Cardiomyopathy, Clinical Trial, P-III, APOLLO-B Study, HFA, 2023
Abbott Reports (AVEIR DR i2i) Study Results of Aveir Dual-Chamber Leadless Pacemaker System
Date: May 22, 2023 | Tags: Abbott, Aveir Dual-Chamber Leadless Pacemaker System, AVEIR DR i2i Study, MedTech
Date: May 22, 2023 | Tags: AbbVie, Epkinly, epcoritamab-bysp, Diffuse Large B-Cell Lymphoma, Regulatory, US, FDA
Date: May 22, 2023 | Tags: Regeneron, Sanofi, Dupixent, dupilumab, chronic obstructive pulmonary disease, Clinical Trial, P-III, BOREAS Trial, ATS, NEJM
Related Post: PharmaShots Weekly Snapshots (May 15 - 19, 2023)
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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.