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PharmaShots Weekly Snapshots (September 26 - 30, 2022)

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PharmaShots Weekly Snapshots (September 26 - 30, 2022)

PharmaShots Weekly Snapshots (September 26 - 30, 2022)

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

Related Post: PharmaShots Weekly Snapshots (September 19 - 23, 2022)


Neha

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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