Date: Feb 03, 2023 | Tags: 4D Molecular Therapeutics, 4D-150, Diabetic Macular Edema, Regulatory, US, FDA, IND
AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma
Date: Feb 03, 2023 | Tags: AstraZeneca, Amgen, Tezspire, Tezepelumab, Severe Asthma, Regulatory, US, FDA, Approval
Abbott Receives the US FDA and EU Approvals for Ablation Technologies to Treat Abnormal Heart Rhythms
Date: Feb 03, 2023 | Tags: Abbott, TactiFlex Sensor Enabled Ablation Catheter, FlexAbility SE Ablation Catheter, Abnormal Heart Rhythms, Regulatory, US, FDA, EU
Shanghai Henlius Biotech Reports the First Patient Dosing of HLX15 (biosimilar, daratumumab) in P-I Clinical Trial for Multiple Myeloma
Date: Feb 03, 2023| Tags: Shanghai Henlius Biotech, HLX15, biosimilar, daratumumab, Multiple Myeloma, Clinical Trial, P-I Trial
Amylyx Reports the Completion of Patient Enrollment in P-III Trial (PHOENIX) of AMX0035 for Amyotrophic Lateral Sclerosis
Date: Feb 03, 2023 | Tags: Amylyx, AMX0035, Amyotrophic Lateral Sclerosis, Clinical Trial, P-III, PHOENIX Trial
Guardant Health Collaborated with AnHeart Therapeutics to Develop Guardant360 CDx and Guardant360 TissueNext for Taletrectinib
Date: Feb 03, 2023 | Tags: Guardant Health, AnHeart Therapeutics, Taletrectinib, Guardant360 CDx, Guardant360 TissueNext
Karuna Therapeutics Entered into an Exclusive License Agreement with Goldfinch Bio for TRPC4/5 Product Candidates
Date: Feb 02, 2023 | Tags: Karuna Therapeutics, Goldfinch Bio, TRPC4/5, GFB-887, psychiatric, neurological conditions, mood, anxiety disorders, Pharma
Tonix Signs a Research Agreement with University of Maryland to Develop TNX-1500 for the Prevention of Rejection in Heart Xenograft Transplantation in Animals
Date: Feb 02, 2023 | Tags: Tonix, University of Maryland, TNX-1500, Rejection, Heart Xenograft Transplantation, Animals Health
Aulos Bioscience Reports the First Patient Dosing of AU-007 in P-I/II Clinical Trial for the Treatment of Solid Tumors
Date: Feb 02, 2023 | Tags: Aulos Bioscience, AU-007, Solid Tumors, Clinical Trial, P-I/II
Orbit Entered into a Multi Target Research Agreement with Endevica Bio to Advance Development of Cachexia Therapies
Date: Feb 02, 2023 | Tags: Orbit Discovery, Endevica Bio, Cachexia, Pharma
Miromatrix Entered into a Collaborative Research Agreement with Baxter to Test Bioengineered Liver Replacement Therapy
Date: Feb 02, 2023 | Tags: Miromatrix, Baxter, Bioengineered Liver Replacement Therapy, miroliverELAP, Acute Liver Failure, PrisMax system, Biotech
GSK’s Jesduvroq (daprodustat) Receives the US FDA’s Approval for the Treatment of Anaemia
Date: Feb 02, 2023 | Tags: GSK, Jesduvroq, daprodustat, Anaemia, chronic kidney disease, Regulatory, US, FDA, Approval
Roche’s Hemlibra (emicizumab) Receives the Label Expansion Approval from EC for Moderate Haemophilia A
Date: Feb 01, 2023 | Tags: Roche, Hemlibra, emicizumab, Moderate Haemophilia, Label Expansion, Approval, EC, Regulatory
Biosynex Entered into a Definitive Merger Agreement to Acquire Chembio Diagnostics for ~$17.2M
Date: Feb 01, 2023 | Tags: Biosynex, Chembio Diagnostics, infectious diseases, ~$17.2M, M&A
Jazz Pharmaceuticals’ Epidyolex (cannabidiol) Receives NICE Recommendation for the Reimbursement to Treat Seizures in England
Date: Feb 01, 2023 | Tags: Jazz Pharmaceuticals, Epidyolex, cannabidiol, Seizures, tuberous sclerosis complex, NICE, England, Regulatory
Amgen Launches First Humira (adalimumab) Biosimilar Amjevita in the US
Date: Feb 01, 2023 | Tags: Amgen, Humira, adalimumab, biosimilar, Amjevita, US
Context Therapeutics’ Clinical Partner Stemline Therapeutics Receives the US FDA’s Approval of Orserdu (elacestrant) for ER+, HER2-, ESR1-Mutated Breast Cancer
Date: Feb 01, 2023 | Tags: Context Therapeutics, Stemline Therapeutics, Orserdu, elacestrant, Breast Cancer, Regulatory, US, FDA, Approval
uniQure Entered into a License Agreement with Apic Bio for APB-102 to Treat Amyotrophic Lateral Sclerosis in Patients with SOD1 Mutations
Date: Feb 01, 2023 | Tags: uniQure, Apic Bio, APB-102, Amyotrophic Lateral Sclerosis, SOD1 Mutations, Pharma
Sciwind Biosciences Initiates the Patient Dosing of Ecnoglutide (XW003) in P-III Clinical Trials for the Treatment of Type 2 Diabetes in China
Date: Jan 31, 2023 | Tags: Sciwind Biosciences, Ecnoglutide, XW003, Type 2 Diabetes, China, Clinical Trial, P-III Trials
Idorsia Reports MAA Submission of Aprocitentan to EMA for the Treatment of Resistant Hypertension
Date: Jan 31, 2023 | Tags: Idorsia, Aprocitentan, Resistant Hypertension, MAA, EMA, Regulatory
Alpha Biopharma Reports the NMPA Acceptance of NDA for Zorifertinib to Treat EGFR-Mutated NSCLC with CNS Metastases
Date: Jan 31, 2023 | Tags: Alpha Biopharma, Zorifertinib, EGFR-Mutated NSCLC, CNS, Metastases, Regulatory, NMPA Acceptance, NDA
Sandoz Receives EMA’s CHMP Positive Opinion of Adalimumab Biosimilar
Date: Jan 31, 2023 | Tags: Sandoz, Hyrimoz, Adalimumab, Biosimilar, rheumatoid arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, uveitis, Regulatory, EMA, CHMP
Daiichi Sankyo Reports the First Patient Dosing of Datopotamab Deruxtecan in P-III Trial (TROPION-Lung07) for Metastatic Non-Small Cell Lung Cancer
Date: Jan 31, 2023 | Tags: Daiichi Sankyo, Datopotamab Deruxtecan, Non-Small Cell Lung Cancer, Clinical Trial, P-III, TROPION-Lung07 Trial
Guardant Health Receives the US FDA’s Approval of Guardant360 CDx Liquid Biopsy Test for Breast Cancer
Date: Jan 31, 2023 | Tags: Guardant Health, Guardant360 CDx Liquid Biopsy Test, Breast Cancer, Regulatory, US, FDA, Approval, MedTech
Janssen Reports P-III Study (CARTITUDE-4) Results of Carvykti (cilta-cel) for the Treatment of Multiple Myeloma
Date: Jan 30, 2023 | Tags: Janssen, Carvykti, cilta-cel, Multiple Myeloma, P-III, CARTITUDE-4 Study, Clinical Trial
Regeneron and Sanofi Receive EC’s Approval of Dupixent (dupilumab) for the Treatment of Eosinophilic Esophagitis
Date: Jan 30, 2023 | Tags: Regeneron, Sanofi, Dupixent, dupilumab, Eosinophilic Esophagitis, Regulatory, EC, Approval
Abbott’s Proclaim XR Spinal Cord Stimulation System Receives the US FDA’s Approval for Painful Diabetic Peripheral Neuropathy
Date: Jan 30, 2023 | Tags: Abbott, Proclaim XR Spinal Cord Stimulation System, Painful Diabetic Peripheral Neuropathy, Regulatory, US, FDA, Approval, MedTech
Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for the Treatment of Non-Small Cell Lung Cancer
Date: Jan 30, 2023 | Tags: Merck, Keytruda, pembrolizumab, Non-Small Cell Lung Cancer, Regulatory, US, FDA, Approval
BMS Receives EMA’s CHMP Positive Opinion of Reblozyl (luspatercept) for Anemia-Associated Non-Transfusion-Dependent Beta Thalassemia
Date: Jan 30, 2023 | Tags: BMS, Reblozyl, luspatercept, Anemia-Associated, Non-Transfusion-Dependent Beta Thalassemia, Regulatory, EMA, CHMP
Eli Lilly’s Jaypirca (pirtobrutinib) Receives the US FDA’s Accelerated Approval for the Treatment of Mantle Cell Lymphoma
Date: Jan 30, 2023 | Tags: Eli Lilly, Jaypirca, pirtobrutinib, Mantle Cell Lymphoma, US, FDA, Approval
Related Post: PharmaShots Weekly Snapshots (January 23 – 27, 2023)
