AbbVie’s Rinvoq (upadacitinib) Receives NICE Recommendation for the Treatment of Active Ulcerative Colitis

Published: Nov 25, 2022 | Tags: AbbVie, Rinvoq, upadacitinib, Ulcerative Colitis, Regulatory, NICE Recommendation

Sirona Biochem Expands it Collaboration with Wanbang Biopharmaceuticals for TFC-039

Published: Nov 25, 2022 | Tags: Sirona Biochem, Wanbang Biopharmaceuticals, TFC-039, diabetes, chronic kidney disease, Pharma

XtalPi Collaborated with CK Life Sciences to Develop AI-Empowered Tumour Vaccine Research and Development Platform

Published: Nov 25, 2022 | Tags: XtalPi, CK Life Sciences, AI-Empowered Tumour Vaccine Platform, sipuleucel-T, melanoma, BCG, bladder cancer, human papillomavirus infection, hepatitis B infection, Pharma

Grünenthal Signed Joint Venture Collaboration Agreement with Kyowa Kirin to Establish Medicines Portfolio

Published: Nov 25, 2022 | Tags: Grünenthal, Kyowa Kirin, Joint Venture, Abstral, PecFent, Moventig, opioid-induced constipation, Adcal-D3, osteoporosis, Pharma

Junshi Biosciences Reports MAA Submission of Toripalimab to the MHRA for Nasopharyngeal Carcinoma and Esophageal Squamous Cell Carcinoma

Published: Nov 25, 2022 | Tags: Junshi Biosciences, Toripalimab, Nasopharyngeal Carcinoma, Esophageal Squamous Cell Carcinoma, MAA, Regulatory

Daiichi Sankyo’ Enhertu (trastuzumab deruxtecan) Receives the MHLW Approval for the Treatment of HER2 Positive Metastatic Breast Cancer

Published: Nov 25, 2022 | Tags: Daiichi Sankyo, Enhertu, trastuzumab deruxtecan, Metastatic Breast Cancer, Regulatory, MHLW, Approval

AnchorDx Reports First Patient Enrollment of UriFind Bladder Cancer Assay for Bladder Cancer in the US

Published: Nov 24, 2022 | Tags: AnchorDx, UriFind Bladder Cancer Assay, Bladder Cancer, US, MedTech

Novartis and Medicines for Malaria Venture Seeks to Advance Ganaplacide/Lumefantrine-SDF Combination Therapy in P-III Study for Malaria

Published: Nov 24, 2022 | Tags: Novartis, Medicines for Malaria Venture, Ganaplacide, Lumefantrine, SDF, Malaria, Clinical Trial, P-III Study

Shionogi Seeks Japan Approval of S-268019 for the Treatment of COVID-19

Published: Nov 24, 2022 | Tags: Shionogi, S-268019, COVID-19, Japan, Approval, Regulatory

Ascletis’ ASC11 Receives the US FDA’s IND Approval for the Treatment COVID-19

Published: Nov 24, 2022 | Tags: Ascletis, ASC11, COVID-19, Regulatory, US, FDA, IND, Approval

UCB Reports P-III Open-Label Extension Study Results of Fintepla (fenfluramine) for Lennox-Gastaut Syndrome

Published: Nov 24, 2022 | Tags: UCB, Fintepla, fenfluramine, Lennox-Gastaut Syndrome, Clinical Trial, P-III Open-Label Extension Study

Xeris Biopharma Entered into a Research Collaboration and Option Agreement with Horizon for XeriJect Formulation of Teprotumumab

Published: Nov 24, 2022 | Tags: Xeris Biopharma, Option Agreement, Horizon, XeriJect, teprotumumab, Pharma

Biosight Initiates First Patient Enrollment in the P-I/II Study of Aspacytarabine + Venetoclax in Acute Myeloid Leukemia’

Published: Nov 23, 2022 | Tags: Biosight, Aspacytarabine, Venetoclax, AML, MDS, Clinical Trial, P-I/II, Induction Therapy

AbbVie’s Skyrizi Receives the EC’s Approval for the Treatment of Moderate to Severe Active Crohn's Disease

Published: Nov 23, 2022 | Tags: AbbVie, Skyrizi, Crohn's Disease, Regulatory, P-III, ADVANCE, MOTIVATE, FORTIFY

Arvinas Reports Results of ARV-471 in P-I/II Study for the Treatment of Breast Cancer

Published: Nov 23, 2022 | Tags: Arvinas, ARV-471, Breast Cancer, ER+/HER2- Breast Cancer, Clinical Trial, P-II, P-I/II, VERITAC

Takeda Reports the US FDA Acceptance of BLA for TAK-003 and Granted Priority Review for the Prevention of Dengue Disease

Published: Nov 23, 2022 | Tags: Takeda, TAK-003, Dengue Disease, Regulatory, US, FDA, BLA

Regeneron’s Libtayo (cemiplimab) Receives EC’s Approval as the 2L Treatment of Recurrent or Metastatic Cervical Cancer

Published: Nov 23, 2022 | Tags: Regeneron, Libtayo, cemiplimab, Cervical Cancer, Regulatory, EC, Approval

uniQure’s Hemgenix (etranacogene dezaparvovec-drlb) Receives the US FDA’s Approval for the Treatment of Hemophilia B

Published: Nov 23, 2022 | Tags: uniQure, Hemgenix, etranacogene dezaparvovec-drlb, Hemophilia B, Regulatory, US, FDA, Approval

argenx Reports the US FDA Acceptance of BLA for Efgartigimod to Treat Generalized Myasthenia Gravis

Published: Nov 22, 2022 | Tags: argenx, Efgartigimod, Generalized Myasthenia Gravis, Regulatory, US, FDA, BLA

Telix Reports the First Patient Dosing of TLX101 in P-II (IPAX-Linz) Study for the Treatment of Glioblastoma

Published: Nov 22, 2022 | Tags: Telix, TLX101, Glioblastoma, P-II IPAX-Linz Study, Clinical Trial

Umoja Biopharma Entered into a Research Collaboration with IASO Biotherapeutics to Develop Off-the-Shelf Therapies for Hematological Malignancies

Published: Nov 22, 2022 | Tags: Umoja Biopharma, IASO Biotherapeutics, Off-the-Shelf Therapies, Hematological Malignancies, iCIL platform, Pharma

AbbVie and Genmab Report the US FDA Acceptance of BLA for Priority Review of Epcoritamab to Treat Large B-Cell Lymphoma

Published: Nov 22, 2022 | Tags: AbbVie, Genmab, Epcoritamab, Large B-Cell Lymphoma, Regulatory, US, FDA, Acceptance, BLA, Priority Review

Graybug Entered into Definitive Merger Agreement with CalciMedica to Advance Auxora for Inflammatory Diseases

Published: Nov 22, 2022 | Tags: Graybug, CalciMedica, Auxora, Inflammatory Diseases, Merger Agreement, Acute pancreatitis, asparaginase-associated pancreatitis, acute kidney injury, and acute hypoxemic respiratory failure, M&A

Merck Entered into a Definitive Agreement to Acquire Imago BioSciences for ~$1.35B

Published: Nov 22, 2022 | Tags: Merck, Imago BioSciences, Acquire, bomedemstat, IMG-7289, myeloproliferative neoplasms, ~$1.35B, M&A

Novavax’s Nuvaxovid Receives Expanded Authorization for COVID-19 in Canada

Published: Nov 21, 2022 | Tags: Novavax, Nuvaxovid, NVX-CoV2373, COVID-19, Canada, Authorization, Regulatory

HiFiBiO Therapeutics Entered into a Clinical Trial Supply Agreement with Novartis to Evaluate HFB200603 + Tislelizumab for DIS Selected Advanced Solid Tumors

Published: Nov 21, 2022 | Tags: HiFiBiO Therapeutics, Novartis, HFB200603, Tislelizumab, DIS Selected Advanced Solid Tumors, Pharma

Provention Bio Reports the US FDA Acceptance of BLA for TZIELD (teplizumab-mzwv) for the Treatment of Stage 2 Type 1 Diabetes

Published: Nov 21, 2022 | Tags: Provention Bio, TZIELD, teplizumab-mzwv, Stage 2 Type 1 Diabetes, Regulatory, US, FDA, BLA

Adaptimmune Reports P-II (SPEARHEAD-1) Trial Results of Afami-cel for the Treatment of Synovial Sarcoma at CTOS 2022

Published: Nov 21, 2022 | Tags: Adaptimmune, Afami-cel, Synovial Sarcoma, Clinical Trial, P-II (SPEARHEAD-1) Trial, CTOS, 2022

Pfizer and BioNTech Report Results of Omicron BA.4/BA.5-Adapted Bivalent Booster for the Treatment of COVID-19

Published: Nov 21, 2022 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted Bivalent Booster, COVID-19, Clinical Trial

Kyowa Kirin and MEI Pharma Reports P-II (MIRAGE) Study Results of Zandelisib for Indolent B-cell Non-Hodgkin’s Lymphoma in Japan

Published: Nov 21, 2022 | Tags: Kyowa Kirin, MEI Pharma, Zandelisib, Indolent B-cell Non-Hodgkin’s Lymphoma, Clinical Trial, P-II (MIRAGE) Study

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