PharmaShots Weekly Snapshots (May 22 – 26, 2023)

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

Akebia Signs a License Agreement with Medice Arzneimittel Pütter GmbH&Co.KG to Commercialize Vafseo for Anemia Associated with CKD

Date: May 26, 2023 | Tags: Akebia, Medice Arzneimittel Pütter GmbH&Co.KG, Vafseo, Anemia, CKD, Pharma 

Daiichi Sankyo’s Vanflyta (quizartinib) Receives the MHLW’s Approval for Newly Diagnosed FLT3-ITD Positive AML

Date: May 26, 2023 | Tags: Daiichi Sankyo, Vanflyta, quizartinib, FLT3-ITD Positive AML, Regulatory, MHLW, Approval 

Merck and Eisai to Present P-III Study (CLEAR) Results of Keytruda + Lenvima as 1L Treatment for Advanced Renal Cell Carcinoma at ASCO 2023

Date: May 26, 2023 | Tags: Merck, Eisai, Keytruda, Lenvima, Advanced Renal Cell Carcinoma, Clinical Trial, P-III, CLEAR Study, ASCO, 2023

Regeneron to Present Updated Results of Linvoseltamab for Patients with Heavily Pre-treated Multiple Myeloma at 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

Oxford BioTherapeutics Expands its Collaboration with Boehringer Ingelheim to Develop Novel Cancer Immunotherapies

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

Immutep Reports P-I Trial (INSIGHT-003) Results of Triple Combination Therapy as 1L Treatment of Non-Small Cell Lung Cancer

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

Novo Nordisk Entered into a Research and Development Collaboration with Life Edit Therapeutics to Develop Gene Editing Therapies for Rare and Cardiometabolic Diseases

Date: May 24, 2023 | Tags: Novo Nordisk, Life Edit Therapeutics, Gene Editing Therapies, rare genetic disorders, Cardiometabolic Diseases, Biotech

Alvotech Extends its Collaboration with Advanz Pharma to Commercialize Five Proposed Biosimilars in EU

Date: May 24, 2023 | Tags: Alvotech, Advanz Pharma, Simponi, Entyvio, AVT23, Xolair, omalizumab, EU, Pharma, Biosimilar

CohBar Entered into Definitive Merger Agreement with Morphogenesis to Advance Late-Stage Oncology Candidates

Date: May 24, 2023 | Tags: CohBar, Morphogenesis, Late-Stage, Oncology, IFx-Hu2.0, M&A

Galapagos Reports the First Patient Dosing of GLPG3667 in the P-II Study (GALARISSO) for the Treatment of Dermatomyositis

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 

Blueprint Medicines Published (PIONEER) Trial Results of Ayvakit (avapritinib) for the Treatment of Indolent Systemic Mastocytosis in the NEJM

Date: May 24, 2023 | Tags: Blueprint Medicines, Ayvakit, avapritinib, Indolent Systemic Mastocytosis, Clinical Trial, PIONEER Trial 

Junshi Biosciences Reports the NMPA Acceptance of sNDA of Toripalimab for Advanced Triple-Negative Breast Cancer

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

Akebia Receives the MHRA’s Approval of Vafseo for Symptomatic Anemia Associated with Chronic Kidney Disease

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 

Blueprint Medicines’ Ayvakit (avapritinib) Receives the US FDA’s Approval as the First Treatment for Indolent Systemic Mastocytosis

Date: May 23, 2023 | Tags: Blueprint Medicine, Ayvakit, avapritinib, Indolent Systemic Mastocytosis, Regulatory, US, FDA, Approval 

Novo Nordisk Reports P-IIIa Trial (OASIS 1) Results of Semaglutide for the Treatment of Obesity or Overweight

Date: May 23, 2023 | Tags: Novo Nordisk, Semaglutide, Obesity, Overweight, Clinical Trial, P-IIIa, OASIS 1 Trial 

BioArctic Partner Eisai Reports the MAA Submission to the MHRA for Lecanemab to Treat Early Alzheimer’s Disease

Date: May 22, 2023 | Tags: BioArctic, Eisai, Lecanemab, Early Alzheimer’s Disease, Regulatory, MAA, MHRA 

Krystal Biotech’s Vyjuvek (beremagene geperpavec) Receives the US FDA’s Approval for Dystrophic Epidermolysis Bullosa in Patients Aged ≥6 Months

Date: May 22, 2023 | Tags: Krystal Biotech, Vyjuvek, beremagene geperpavec, Dystrophic Epidermolysis Bullosa, Regulatory, US, FDA, Approval 

Alnylam Presents 18-Month P-III Study (APOLLO-B) Results of Patisiran for ATTR Amyloidosis with Cardiomyopathy at HFA 2023

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 

AbbVie and Genmab’s Epkinly (epcoritamab-bysp) Receives the US FDA’s Approval for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Date: May 22, 2023 | Tags: AbbVie, Epkinly, epcoritamab-bysp, Diffuse Large B-Cell Lymphoma, Regulatory, US, FDA

Regeneron and Sanofi Presented P-III Trial (BOREAS) Results of Dupixent (dupilumab) for Chronic Obstructive Pulmonary Disease at ATS and Published in the NEJM

Date: May 22, 2023 | Tags: Regeneron, Sanofi, Dupixent, dupilumab, chronic obstructive pulmonary disease, Clinical Trial, P-III, BOREAS Trial, ATS, NEJM

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