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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