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

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