PharmaShots Weekly Snapshots (February 20 - 24, 2023)

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PharmaShots Weekly Snapshots (February 20 - 24, 2023)


Akebia Receives EMA’s CHMP Positive Opinion of Vafseo (vadadustat) for Symptomatic Anaemia Associated with Chronic Kidney Disease

Date: Feb 24, 2023 | Tags: Akebia, Vafseo, vadadustat, Symptomatic Anaemia, Chronic Kidney Disease, Regulatory, EMA, CHMP 

Regeneron Reports the US FDA Acceptance of BLA for Priority Review of Aflibercept for Wet Age-Related Macular Degeneration and Diabetic Macular Edema

Date: Feb 24, 2023 | Tags: Regeneron, Aflibercept, Wet Age-Related Macular Degeneration, Diabetic Macular Edema, Regulatory, US, FDA, BLA, Priority Review 

Sanofi’s Altuviiio Receives the US FDA’s Approval for the Treatment of Hemophilia A

Date: Feb 24, 2023 | Tags: Sanofi, Altuviiio, Hemophilia A, Regulatory, US, FDA, Approval 

UniQure and CSL Published P-III Study (HOPE-B) Results of Hemgenix (etranacogene dezaparvovec-drlb) for Hemophilia in NEJM

Date: Feb 24, 2023 | Tags: UniQure, CSL, Hemgenix, etranacogene dezaparvovec-drlb, Hemophilia, Clinical Trial, P-III, HOPE-B Study, NEJM

MEI Pharma Signs a Definitive Merger Agreement with Infinity Pharmaceuticals to Advance Three Clinical Oncology Candidates

Date: Feb 24, 2023 | Tags: MEI Pharma, Infinity Pharmaceuticals, Eganelisib, Voruciclib, ME-344, head and neck squamous cell carcinoma, hematologic malignancies, colorectal cancer, M&A

VBL Therapeutics Reverse Merged with Notable Labs to Advance Predictive Precision Medicines Platform and Therapeutic Pipeline

Date: Feb 24, 2023 | Tags: VBL Therapeutics, Notable Labs, Predictive Precision Medicines Platform, volasertib, cancer, M&A

AbbVie Expands its Collaboration with Capsida Biotherapeutics to Develop Targeted Genetic Therapies for Eye Diseases

Date: Feb 23, 2023 | Tags: AbbVie, Capsida Biotherapeutics, Genetic Therapies, Eye Diseases, Pharma 

Pfizer’s Reports the US FDA and EMA’s Acceptance of BLA and MAA for Elranatamab for Multiple Myeloma

Date: Feb 23, 2023 | Tags: Pfizer, Elranatamab, Multiple Myeloma, Regulatory, US, FDA, EMA, BLA, MAA  

Keymed and Lepu Biopharma Enter into an Exclusive License Agreement with AstraZeneca for CMG901 to Treat Claudin 18.2-Positive Solid Tumors

Date: Feb 23, 2023 | Tags: Keymed, Lepu Biopharma, AstraZeneca, CMG901, Claudin 18.2-Positive Solid Tumors, Pharma

Moderna and Merck Receive the US FDA’s Breakthrough Therapy Designation for mRNA-4157/V940 + Keytruda (pembrolizumab) to Treat High-Risk Melanoma

Date: Feb 23, 2023 | Tags: Moderna, Merck, mRNA-4157/V940, Keytruda, pembrolizumab, Melanoma, regulatory, US, FDA, Breakthrough Therapy Designation 

Vir Biotechnology’s Sotrovimab Receives NICE Recommendation for COVID-19

Date: Feb 23, 2023 | Tags: Vir Biotechnology, Sotrovimab, COVID-19, NICE, Regulatory, Xtend technology

Axsome Therapeutics Entered into an Exclusive License Agreement with Pharmanovia to Develop and Commercialize Sunosi (solriamfetol) in Europe

Date: Feb 23, 2023 | Tags: Axsome Therapeutics, Pharmanovia, Sunosi, solriamfetol, Pharma, Europe

Ono Entered into a Collaboration and Option Agreement with Cue Biopharma for CUE-401 to Treat Autoimmune and Inflammatory Diseases

Date: Feb 22, 2023 | Tags: Ono, Cue Biopharma, CUE-401, Autoimmune, Inflammatory Diseases, Immuno-STAT, Pharma

AstraZeneca’s Imfinzi (durvalumab) + Imjudo (tremelimumab) Receives EU Approval for Advanced Liver and Non-Small Cell Lung Cancer

Date: Feb 22, 2023 | Tags: AstraZeneca, Imfinzi, durvalumab, Imjudo, tremelimumab, Liver, Non-Small Cell Lung Cancer, Regulatory, EU, Approval 

Merck’s Lagevrio (molnupiravir) Missed Primary Endpoints in P-III Trial (MOVe-AHEAD) for Post-Exposure Prophylaxis to Prevent COVID-19

Date: Feb 22, 2023 | Tags:  Merck, Lagevrio, molnupiravir, Post-Exposure Prophylaxis, COVID-19, Clinical Trial, P-III, MOVe-AHEAD Trial

Karyopharm and Menarini Receive MHRA’s Marketing Authorization of Nexpovio (selinexor) for the Treatment of Multiple Myeloma

Date: Feb 22, 2023 | Tags: Karyopharm, Menarini, Nexpovio, Selinexor, Multiple Myeloma, MHRA, Marketing Authorization 

Arcutis Reports the NDA Submission of Roflumilast to the US FDA for the Treatment of Seborrheic Dermatitis

Date: Feb 22, 2023 | Tags: Arcutis, Roflumilast, Seborrheic Dermatitis, Regulatory, US, FDA, NDA 

Regeneron Report the US FDA Acceptance of BLA for Priority Review of Pozelimab for the Treatment of Ultra-Rare Chaple Disease

Date: Feb 22, 2023 | Tags: Regeneron, Pozelimab, Ultra-Rare Chaple Disease, Regulatory, US, FDA, BLA, Priority Review 

Bridge Biotherapeutics Reports P-IIa Clinical Trial Results of BBT-401 for the Treatment of Ulcerative Colitis

Date: Feb 21, 2023 | Tags: Bridge Biotherapeutics, BBT-401, Ulcerative Colitis, Clinical Trial, P-IIa Trial

Junshi Biosciences Reports P-III (TORCHLIGHT Study) Results of Toripalimab for Advanced Triple-Negative Breast Cancer

Date: Feb 21, 2023 | Tags:  Junshi Biosciences, Toripalimab, Triple-Negative Breast Cancer, Clinical Trial, P-III, TORCHLIGHT Study 

Travere Therapeutics’ Filspari (sparsentan) Receives the US FDA’s Accelerated Approval for the Reduction of Proteinuria in IgA Nephropathy

Date: Feb 21, 2023 | Tags: Travere Therapeutics, Filspari, sparsentan, Proteinuria, IgA Nephropathy, Regulatory, US, FDA, Accelerated Approval

Apellis’ Syfovre Receives the US FDA’s Approval as the First Treatment for Geographic Atrophy

Date: Feb 21, 2023 | Tags: Apellis, Syfovre, Geographic Atrophy, Regulatory, US, FDA, Approval 

BMS Reports P-III Trial (CheckMate-274) Results of Opdivo (nivolumab) for High-Risk Muscle-Invasive Urothelial Carcinoma

Date: Feb 21, 2023 | Tags: BMS, Opdivo, nivolumab, Muscle-Invasive Urothelial Carcinoma, Clinical Trial, P-III, CheckMate -274 Trial 

CSL’s Hemgenix (etranacogene dezaparvovec) Receives EC’s Conditional Marketing Authorization for Hemophilia B

Date: Feb 21, 2023 | Tags: CSL, Hemgenix, etranacogene dezaparvovec, Hemophilia B, Regulatory, EC, Conditional Marketing Authorization 

Telix Presented P-III Results from TLX250-CDx for Kidney Cancer Imaging Study at the ASCO GU 2023

Date: Feb 20, 2023 | Tags: Telix, TLX250-CDx, Kidney Cancer, Clinical Trial, P-III, Imaging Study, ASCO GU 2023 

Takeda Reports Results of Vedolizumab in P-III Trial for the Prevention of Intestinal aGvHD in Patients Undergoing allo-HSCT

Date: Feb 20, 2023 | Tags: Takeda, Vedolizumab, Intestinal aGvHD, Clinical Trial, P-III, GRAPHITE

NurExone Reports Preclinical Results of ExoPTEN for the Treatment of Traumatic Spinal Cord Injuries

Date: Feb 20, 2023 | Tags: NurExone, ExoPTEN, Traumatic Spinal Cord Injuries, Clinical Trial, ExoTherapy, Preclinical Study, Interim Results 

Mazen Animal Health Receives Patent from the USPTO for its Oral Porcine Epidemic Diarrhea Virus (PEDV) Vaccine

Date: Feb 20, 2023 | Tags: Mazen Animal Health, Porcine Epidemic Diarrhea Virus Vaccine, PEDV, Animal Health, USPTO, Patent, Vaccines 

Pfizer and Valneva Report Partial Discontinuation of Patient Evaluation in P-III Clinical Trial for VLA15 to Treat Lyme Disease

Date: Feb 20, 2023 | Tags: Pfizer, Valneva, VLA15, Lyme Disease, Clinical Trial, P-III, VALOR, US FDA, BLA, EMA, MAA 

Clover and Adimmune Enters into Exclusive Agreement to Commercialize AdimFlu-S (QIS) Influenza Vaccine in Mainland China

Date: Feb 20, 2023 | Tags: Clover, Adimmune, AdimFlu-S (QIS), Biotech, Influenza Vaccine, NMPA, China, Bangladesh, Brazil, and the Philippines

Related Post: PharmaShots Weekly Snapshots (February 13 - 17, 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.

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