Biogen Reports the EMA Acceptance of MAA for BIIB800 (biosimilar, tocilizumab)

Published: Sept 30, 2022 | Tags: Biogen, BIIB800, RoACTEMRA, biosimilar, tocilizumab, EMA, MAA

Zealand Pharma Reports P-III (EASE 1) Trial Results of Glepaglutide for the Treatment of Short Bowel Syndrome

Published: Sept 30, 2022 | Tags: Zealand Pharma, Glepaglutide, Short Bowel Syndrome, Clinical Trial, P-III, EASE 1 Trial

Astellas Reports EMA’s Acceptance of MAA for Fezolinetant to Treat Vasomotor Symptoms Associated with Menopause

Published: Sept 30, 2022 | Tags: Astellas, Fezolinetant, Vasomotor Symptoms, Menopause, Regulatory, EMA, MAA

SpringWorks Therapeutics Reports First Patient Dosing in the P-II Trial of Nirogacestat for the Treatment of Ovarian Granulosa Cell Tumors

Published: Sept 30, 2022 | Tags: SpringWorks Therapeutics, Nirogacestat, Ovarian Granulosa Cell Tumors, Clinical Trial, P-II Trial

Horizon Reports the Completion of Patient Enrollment of Tepezza (teprotumumab-trbw) in P-IV Trial for Thyroid Eye Disease

Published: Sept 30, 2022 | Tags: Horizon, Tepezza, teprotumumab-trbw, Clinical Trial, P-IV Trial, Thyroid Eye Disease

Amylyx’s Relyvrio (sodium phenylbutyrate and taurursodiol) Receives the US FDA’s Approval for the Treatment of ALS

Published: Sept 30, 2022 | Tags: Amylyx, Relyvrio, sodium phenylbutyrate, taurursodiol, Regulatory, US, FDA, Approval

Sanofi and Regeneron’s Dupixent (dupilumab) Receive the US FDA’s Approval as 1L Treatment for Prurigo Nodularis

Published: Sept 29, 2022 | Tags: Sanofi, Regeneron, Dupixent, dupilumab, Prurigo Nodularis, Regulatory, US, FDA, Approval

Ventus Entered into an Exclusive Development and License Agreement with Novo Nordisk for NLRP3 Inhibitor Program to Treat Cardiometabolic Diseases

Published: Sept 29, 2022 | Tags: Ventus Therapeutics, Novo Nordisk, NLRP3 Inhibitor Program, Cardiometabolic Diseases, non-alcoholic steatohepatitis, chronic kidney disease, Pharma,

Ascletis Reports First Patient Dosing in the P-IIb Expansion Cohort of ASC22 (envafolimab) for Chronic Hepatitis B

Published: Sept 29, 2022 | Tags: Ascletis, ASC22, envafolimab, Chronic Hepatitis B, Clinical Trial, P-IIb Expansion Cohort

MaxCyte Signed a Non-Exclusive License Agreement with Vertex to Advance CTX001 Transfusion-Dependent Beta Thalassemia or Sickle Cell Disease

Published: Sept 29, 2022 | Tags: MaxCyte, Vertex, CTX001, Transfusion-Dependent Beta Thalassemia, Sickle Cell Disease, Pharma, ExPERT platform, Flow Electroporation technology

MorphoSys Reports (L-MIND) Study Results of Monjuvi (tafasitamab-cxix) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Published: Sept 29, 2022 | Tags: MorphoSys, Monjuvi, tafasitamab-cxix, Diffuse Large B-Cell Lymphoma, Clinical Trial, L-MIND Study

Simcere Entered into an Exclusive License Agreement with Almirall for SIM0278 to Treat Autoimmune Diseases

Published: Sept 29, 2022 | Tags: Simcere, Almirall, SIM0278, Autoimmune Diseases, Pharma

Celltrion’s Vegzelma (biosimilar, bevacizumab) Receives the US FDA’s Approval for the Treatment of Cancers

Published: Sept 28, 2022 | Tags: Celltrion, Vegzelma, biosimilar, bevacizumab, Regulatory, US, FDA, Approval, Cancers

BioArctic Partner Eisai Reports P-III (Clarity AD) Study Results of Lecanemab for the Treatment of Alzheimer's Disease

Published: Sept 28, 2022 | Tags: BioArctic, Eisai, Lecanemab, Alzheimer's Disease, Clinical Trial, P-III, Clarity AD Study

aTyr Pharma Reports the First Patient Dosing in the P-III (EFZO-FIT) Study of Efzofitimod for the Treatment of Pulmonary Sarcoidosis

Published: Sept 28, 2022 | Tags: aTyr Pharma, Efzofitimod, Pulmonary Sarcoidosis, Clinical Trial, P-III, EFZO-FIT Study

Avidity Biosciences Reports the US FDA's Clinical Hold on P-I/II (MARINA) Trial of AOC 1001 for Myotonic Dystrophy Type 1

Published: Sept 28, 2022 | Tags: Avidity Biosciences, AOC 1001, Myotonic Dystrophy Type 1, Clinical Trial, US, FDA, Clinical Hold, P-I/II, MARINA Trial

Arsenal Entered into a Multi-Year Collaboration with Genentech to Identify T-Cell Therapies for Cancer

Published: Sept 28, 2022 | Tags: Arsenal, Genentech, T-Cell Therapies, Biotech, Cancer

Seagen Entered into an Exclusive Collaboration and License Agreement with Zai Lab to Develop and Commercialize Tivdak (tisotumab vedotin-tftv)

Published: Sept 28, 2022 | Tags: Seagen, Zai Lab, Tivdak, tisotumab vedotin-tftv, Pharma, Cancer

Sanofi Entered into a Research Collaboration with Scribe Therapeutics to Advance CRISPR-based Cell Therapies for Cancer

Published: Sept 27, 2022 | Tags: Sanofi, Scribe Therapeutics, CRISPR-based Cell Therapies, Cancer, pharma

Sciwind Biosciences Entered into a Research Collaboration with SynerK to Develop Novel siRNA Therapies for Liver and Metabolic Diseases

Published: Sept 27, 2022 | Tags: Sciwind Biosciences, SynerK, siRNA Therapies, Pharma, Liver, Metabolic Diseases

Arcutis Reports P-III (ARRECTOR) Trial Results of Roflumilast Foam for the Treatment of Scalp and Body Psoriasis

Published: Sept 27, 2022 | Tags: Arcutis, Roflumilast Foam, Scalp, Body Psoriasis, Clinical Trial, P-III ARRECTOR Trial

Daiichi Sankyo’s Ezharmia (valemetostat tosilate) Receives MHLW Approval for the Treatment of T-Cell Leukemia/ Lymphoma in Japan

Published: Sept 27, 2022 | Tags: Daiichi Sankyo, Ezharmia, valemetostat tosilate, T-Cell Leukemia, Lymphoma, Regulatory, Japan, MHLW Approval

KiOmed Pharma Entered into a License Agreement with Hansoh Pharma to Develop and Commercialize KiOmedinevsOne for Knee Osteoarthritis

Published: Sept 27, 2022 | Tags: KiOmed Pharma, Hansoh Pharma, KiOmedinevsOne, Knee Osteoarthritis, Pharma

Seagen Entered into an Exclusive License Agreement with L­AVA Therapeutics for LAVA-1223 to Treat EGFR-Expressing Solid Tumors

Published: Sept 27, 2022 | Tags: Seagen, LAVA Therapeutics, LAVA-1223, EGFR-Expressing Solid Tumors, Pharma

Pfizer and BioNTech Report EUA Submission to the US FDA for Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster in Children Aged 5-11 Years

Published: Sept 26, 2022 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster, EUA, US, FDA, Regulatory, COVID-19

TILT Biotherapeutic Entered into a Clinical Trial Collaboration and Supply Agreement with MSD to Evaluate TILT-123 for Refractory Non-Small Cell Lung Cancer

Published: Sept 26, 2022 | Tags: TILT Biotherapeutics, MSD, TILT-123, Non-Small Cell Lung Cancer, Pharma

CellOrigin Biotech Collaborated with Qilu Pharma to Develop Off-the-Shelf CAR-iMAC Cell Therapy for Cancer

Published: Sept 26, 2022 | Tags: CellOrigin Biotech, Qilu Pharma, Off-the-Shelf, CAR-iMAC Cell Therapy, Cancer, Pharma

Innate Pharma Presents Preliminary P-II (TELLOMAK) Trial Results of Lacutamab for the Treatment of Advanced Mycosis Fungoides

Published: Sept 26, 2022 | Tags: Innate Pharma, Lacutamab, Advanced Mycosis Fungoides, Clinical Trials, P-II, TELLOMAK Trial

Everest Medicines Receives the NMPA’s IND Approval for EVER001 to Treat Renal Diseases

Published: Sept 26, 2022 | Tags: Everest Medicines, EVER001, Renal Diseases, Regulatory, NMPA, IND, Approval 

AstraZeneca’s Ultomiris (ravulizumab) Receive EC’s Approval for the Treatment of Generalised Myasthenia Gravis

Published: Sept 26, 2022 | Tags: AstraZeneca, Ultomiris, ravulizumab, Generalised Myasthenia Gravis, Regulatory, EC, Approval

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