PharmaShots Weekly Snapshots (May 22 - 26, 2023)

Share this

PharmaShots Weekly Snapshots (May 22 - 26, 2023)

Takeda and HUTCHMED's Fruquintinib Receives Priority Review from the US FDA to Treat Metastatic Colorectal Cancer

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

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

Related Post: PharmaShots Weekly Snapshots (May 15 - 19, 2023)

Senior Editor

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.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions