Quell Therapeutics Signed an Exclusive Option and License Agreement with AstraZeneca to Develop, Manufacture and Commercialize Engineered Treg Cell Therapies

Date: June 09, 2023 | Tags: Quell Therapeutics, AstraZeneca, Engineered Treg Cell Therapies, Type 1 Diabetes, Inflammatory Bowel Disease, Biotech, Treg cell engineering modules

Astellas and the Blood and Marrow Transplant Clinical Trials Network Report P-III Trial (MORPHO) Results of Gilteritinib for FLT3-ITD Acute Myeloid Leukemia

Date: June 09, 2023 | Tags: Astellas, Blood and Marrow Transplant Clinical Trials Network, Gilteritinib, FLT3-ITD, Acute Myeloid Leukemia, Clinical Trial, P-III, MORPHO Trial

Merck Reports the US FDA Acceptance of sBLA for Keytruda (pembrolizumab) to Treat Advanced or Unresectable Biliary Tract Cancer

Date: June 09, 2023 | Tags: Merck, Keytruda, pembrolizumab, Biliary Tract Cancer, Regulatory, US, FDA, sBLA

Acadia Pharmaceuticals Reports P-III Study (LAVENDER) Results of Daybue (trofinetide) for the Treatment of Rett Syndrome

Date: June 09, 2023 | Tags: Acadia Pharmaceuticals, Daybue, trofinetide, Rett Syndrome, Clinical Trial, P-III, LAVENDER Study

Zhaoke Ophthalmology Signed an Exclusive License, Supply and Distribution Agreement with Eyedetec Medical to Commercialize Eye Lipid Mobilizer

Date: June 09, 2023 | Tags: Zhaoke Ophthalmology, Eyedetec Medical, Eye Lipid Mobilizer, dry eye disease, MedTech

Astellas Entered into an Exclusive License Agreement with Kate Therapeutics to Develop and Commercialize KT430

Date: June 09, 2023 | Tags: Astellas, Kate Therapeutics, KT430, X-linked myotubular myopathy, Pharma

Henlius Presents P-II Clinical Trial (HLX07-ESCC201) Results of HLX07 for the Treatment of Esophageal Squamous Cell Carcinoma at ASCO 2023

Date: June 08, 2023 | Tags: Henlius, HLX07, Esophageal Squamous Cell Carcinoma, Clinical Trial, Clinical Trial, P-II, HLX07-ESCC201 Trial

Vera Therapeutics Reports the Initiation of Atacicept in the P-III Trial (ORIGIN 3) for the Treatment of IgA Nephropathy

Date: June 08, 2023 | Tags: Vera Therapeutics, Atacicept, IgA Nephropathy, Clinical Trial, P-III, ORIGIN 3 Trial

BioArctic Partner Eisai Reports the MAA Submission to the MFDS for Lecanemab to Treat Early Alzheimer's Disease

Date: June 08, 2023 | Tags: BioArctic, Eisai, MFDS, Lecanemab, Early Alzheimer's Disease, Regulatory, MAA

Merck’s Prevymis (letermovir) Receives the US FDA’s Approval for Prevention of Cytomegalovirus Disease

Date: June 08, 2023 | Tags: Merck, Prevymis, letermovir, Cytomegalovirus Disease, Regulatory, US, FDA, Approval

FibroGen’s Pamrevlumab Failed to Meet its Primary Endpoints in P-III Trial (LELANTOS-1) for the Treatment of Duchenne Muscular Dystrophy

Date: June 08, 2023 | Tags: FibroGen, Pamrevlumab, Duchenne Muscular Dystrophy, Clinical Trial, P-III, LELANTOS-1 Trial

Merck and AstraZeneca's Lynparza (Olaparib) Receive NICE Recommendation for Maintenance Treatment of BRCA-Mutated Cancers

Date: June 08, 2023 | Tags: Merck, AstraZeneca, Lynparza, Olaparib, BRCA-Mutated Ovarian Cancer, Regulatory, NICE Recommendation

AbTherx Entered into a License Agreement with Gilead to Develop and Commercialize Novel Transgenic Mouse Technologies

Date: June 07, 2023 | Tags: AbTherx, Gilead, Transgenic Mouse Technologies, Atlas Mice, Biotech

GSK’s Arexvy Receives EC’s Approval for the Prevention of Lower Respiratory Tract Disease in Individuals Aged ≥60 Years

Date: June 07, 2023 | Tags: GSK, Arexvy, Lower Respiratory Tract Disease, Regulatory, EC, Approval

Zai Lab and Novocure Report P-III Trial (LUNAR) Results of Tumor Treating Fields Therapy for Metastatic Non-Small Cell Lung Cancer

Date: June 07, 2023 | Tags: Zai Lab, Novocure, Tumor Treating Fields Therapy, Metastatic Non-Small Cell Lung Cancer, Clinical Trial, P-III, LUNAR Trial

Janssen and Legend Biotech Report the sBLA Submission of Carvykti (ciltacabtagene autoleucel) to the US FDA for Relapsed or Refractory Multiple Myeloma

Date: June 07, 2023 | Tags: Janssen, Carvykti, ciltacabtagene autoleucel, Multiple Myeloma, Regulatory, US, FDA, sBLA

UCB’s Bimzelx (bimekizumab) Receives EC’s Marketing Authorisation for the Treatment of Psoriatic Arthritis and Axial Spondyloarthritis

Date: June 07, 2023 | Tags: UCB, Bimzelx, bimekizumab, Psoriatic Arthritis, Axial Spondyloarthritis, Regulatory, EC, Marketing Authorisation

Kite Reports Real-World Analysis Results of Tecartus (brexucabtagene autoleucel) for Relapsed/Refractory Mantle Cell Lymphoma

Date: June 07, 2023 | Tags: Kite, Tecartus, brexucabtagene autoleucel, Mantle Cell Lymphoma, Clinical Trial

Fennec Pharmaceuticals’ Pedmarqsi (sodium thiosulfate) Receives EC’s Marketing Authorization for Cisplatin-Induced Ototoxicity

Date: June 06, 2023 | Tags: Fennec Pharmaceuticals, Pedmarqsi, sodium thiosulfate, Hearing Loss, Regulatory, EC, Marketing Authorization

GSK Reports the US FDA Acceptance of sBLA for Jemperli (dostarlimab) to Treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer

Date: June 06, 2023 | Tags: GSK, Jemperli, dostarlimab, dMMR/MSI-H, Endometrial Cancer, Regulatory, US, FDA, sBLA

Rani Therapeutics Expands its Collaboration with Celltrion to Develop Oral Version of Humira Biosimilar RT-105

Date: June 06, 2023 | Tags: Rani Therapeutics, Celltrion, Humira, Biosimilar, CT-P17, RT-105, Pharma

Gilead to Presents P-III (TROPiCS-02) Study Results of Trodelvy (sacituzumab govitecan) for Pre-Treated HR+/HER2- Metastatic Breast Cancer at ASCO 2023

Date: June 06, 2023 | Tags: Gilead, Trodelvy, sacituzumab govitecan, HR+/HER2- Metastatic Breast Cancer, Clinical Trial, P-III, TROPiCS-02 Study, ASCO, 2023

AstraZeneca & Daiichi Sankyo Report Interim Analysis Results of Enhertu (trastuzumab deruxtecan) in the P-II Trial (DESTINY-PanTumor02) for HER2-Expressing Advanced Solid Tumors

Date: June 06, 2023 | Tags: AstraZeneca, Enhertu, trastuzumab deruxtecan, Solid Tumors, Clinical Trial, P-II, DESTINY-PanTumor02 Trial

NRx Collaborated with Lotus and Alvogen to Develop and Commercialize NRX-101 for Suicidal Treatment-Resistant Bipolar Depression

Date: June 06, 2023 | Tags: NRx, Lotus, Alvogen, NRX-101, Suicidal Treatment-Resistant Bipolar Depression, Pharma

Dr. Reddy Reports the Completion of the P-I Study of DRL_TC, a Proposed Biosimilar of Tocilizumab for Rheumatoid Arthritis

Date: June 05, 2023 | Tags: Dr. Reddy, DRL_TC, Biosimilar, Tocilizumab, Rheumatoid Arthritis, Clinical Study, P-I Study

AstraZeneca Presents Reports P-III Trial (ADAURA) Results of Tagrisso (osimertinib) for Early-Stage EGFR-Mutated Lung Cancer at ASCO 2023

Date: June 05, 2023 | Tags: AstraZeneca, Tagrisso, Osimertinib, Early-Stage EGFR-Mutated Lung Cancer, Clinical Trial, P-III, ADAURA Trial

Terran Biosciences Entered into an Exclusive License Agreement with Pierre Fabre for Idazoxan to Treat Schizophrenia

Date: June 05, 2023 | Tags: Terran Biosciences, Pierre Fabre, Idazoxan, Schizophrenia, Pharma

Innovent’s Olverembatinib Receives the NMPA’s Breakthrough Therapy Designation for Succinate Dehydrogenase-Deficient Gastrointestinal Stromal Tumor

Date: June 05, 2023 | Tags: Innovent, Olverembatinib, Succinate Dehydrogenase-Deficient Gastrointestinal Stromal Tumor, Regulatory, NMPA, Breakthrough Therapy Designation

Jazz and Zymeworks Present P-IIb Trial (HERIZON-BTC-01) Results of Zanidatamab for HER2-Amplified Biliary Tract Cancers at ASCO 2023

Date: June 05, 2023 | Tags: Jazz, Zymeworks, Zanidatamab, HER2-Amplified Biliary Tract Cancers, Clinical Trial, P-IIb, HERIZON-BTC-01 Trial, ASCO, 2023

Gilead and Arcus Present P-II Study (ARC-7) Results of Domvanalimab as 1L Treatment of Non-Small Cell Lung Cancer at ASCO 2023

Date: June 05, 2023 | Tags: Gilead, Arcus, Domvanalimab, Non-Small Cell Lung Cancer, Clinical Trial, P-II, ARC-7 Study, ASCO, 2023

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