PharmaShots Weekly Snapshots (November 21 - 25, 2022)

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PharmaShots Weekly Snapshots (November 21 - 25, 2022)

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

Related Post: PharmaShots Weekly Snapshots (November 14 - 18 2022)


Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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