BMS Reports the US FDA Acceptance of sBLA for Priority Review of Breyanzi (lisocabtagene maraleucel) as a 2L Treatment for Large B-cell Lymphoma

Published: Feb 18, 2022 | Tags: BMS, US, FDA, sBLA, Priority Review, Breyanzi, lisocabtagene maraleucel, Large B-cell Lymphoma

Regeneron and Sanofi Stop P-III (CUPID STUDY B) Trial of Dupixent (dupilumab) for the Treatment of Chronic Spontaneous Urticaria

Published: Feb 18, 2022 | Tags: Regeneron, Sanofi, Dupixent, dupilumab, P-III, CUPID STUDY B, Chronic Spontaneous Urticaria

BMS Presents Interim Results of Zeposia (ozanimod) in P-III (True North) OLE Study for the Treatment of Active Ulcerative Colitis at ECCO 2022

Published: Feb 18, 2022 | Tags: BMS, Zeposia, ozanimod, P-III, True North, OLE Study, Ulcerative Colitis, ECCO 2022

Novavax Receives the Health Canada Marketing Authorization for Nuvaxovid (NVX-CoV2373) to Treat COVID-19

Published: Feb 18, 2022 | Tags: Novavax, Health Canada, Marketing  Authorization, NVX-CoV2373, COVID-19

UCB’s Bimzelx (bimekizumab) Receives Health Canada’s Approval for the Treatment of Plaque Psoriasis

Published: Feb 18, 2022 | Tags: UCB, Bimzelx, bimekizumab, Health Canada, Approval, Plaque Psoriasis

Janssen Entered into a Collaboration with Remix to Advance Small Molecule Therapies Using REMaster Drug Discovery Platform

Published: Feb 18, 2022 | Tags: Janssen, Remix, Small Molecule, Therapies, REMaster Drug Discovery Platform

BMS Reports Results of Mavacamten in P-III (VALOR-HCM) Study for the Treatment of Obstructive Hypertrophic Cardiomyopathy

Published: Feb 17, 2022 | Tags: BMS, Mavacamten, P-III, ALOR-HCM Study, Obstructive Hypertrophic Cardiomyopathy

BeiGene’s Brukinsa (zanubrutinib) Receives Swissmedic Approval for the Treatment of Adult Patients with Waldenström’s Macroglobulinemia

Published: Feb 17, 2022 | Tags: BeiGene, Brukinsa, zanubrutinib, Swissmedic Approval, Waldenström’s Macroglobulinemia

Pfizer and OPKO’s Ngenla (somatrogon) Receives EC’s Marketing Authorization for the Treatment of Pediatric Growth Hormone Deficiency

Published: Feb 17, 2022 | Tags: Pfizer, OPKO, Ngenla, somatrogon, EC, Marketing Authorization, Pediatric, Growth Hormone, Deficiency

LEXEO Receives the US FDA’s IND Clearance of LX2006 for the Treatment of Friedreich’s Ataxia Cardiomyopathy

Published: Feb 17, 2022 | Tags: LEXEO, US, FDA, IND, LX2006, Friedreich’s Ataxia Cardiomyopathy

Gilead Reports One-Year Results of Lenacapavir in P-II/III (CAPELLA) & P-II (CALIBRATE) Trial for the Treatment of HIV

Published: Feb 17, 2022 | Tags: Gilead, Lenacapavir, P-II/III, CAPELLA, P-II, CALIBRATE Trial, HIV

Sage and Biogen Report Results of Zuranolone in P-III (CORAL) Study for the Treatment of Major Depressive Disorder

Published: Feb 17, 2022 | Tags: Sage, Biogen, Zuranolone, P-III, CORAL Study, Major Depressive Disorder

GBT’s Oxbryta (voxelotor) Receives EC’s Approval for the Treatment of Hemolytic Anemia in Patients with Sickle Cell Disease

Published: Feb 16, 2022 | Tags: GBT, Oxbryta, voxelotor, EC, Approval, Hemolytic Anemia, Sickle Cell Disease

Cytokinetics Presents Results of Omecamtiv Mecarbil in P-III (METEORIC-HF) Trial for Heart Failure with Reduced Ejection Fraction at ACC 2022

Published: Feb 16, 2022 | Tags: Cytokinetics, Omecamtiv Mecarbil, P-III, METEORIC-HF Trial, Heart Failure, Reduced Ejection Fraction

HOOKIPA Entered into an Amended and Restated Collaboration and License Agreement with Gilead to Develop Arenaviral Immunotherapies for HIV

Published: Feb 16, 2022 | Tags: HOOKIPA, Gilead, Immunotherapies, HIV

BMS & Exelixis Present Two Years Follow-Up Results of Opdivo (nivolumab) + Cabometyx (cabozantinib) in P-III (CheckMate -9ER) Trial for RCC at ASCO 2022

Published: Feb 16, 2022 | Tags: BMS, Exelixis, Opdivo, nivolumab, Cabometyx, cabozantinib, P-III, CheckMate -9ER Trial, RCC, ASCO 2022

Intellia Signs a License and Collaboration Agreement with ONK to Advance Allogeneic CRISPR-Edited NK Cell Therapies for Cancer

Published: Feb 16, 2022 | Tags: Intellia, ONK, Allogeneic, CRISPR-Edited, NK Cell Therapies, Cancer

Eli Lilly Signs a ~$1.7B License Agreement with ImmunoGen to Develop & Commercialize ADCs for Cancer

Published: Feb 16, 2022 | Tags: Eli Lilly, ~$1.7B, ImmunoGen, ADCs, Cancer

AstraZeneca Reports Results of Lynparza + Abiraterone in P-III PROpel Study for 1L Metastatic Castration-Resistant Prostate Cancer

Published: Feb 15, 2022 | Tags: AstraZeneca, Lynparza, Abiraterone, P-III, PROpel Study, 1L, Metastatic Castration-Resistant Prostate Cancer

Zealand Pharma Report Enrollment Completion in P-III Study of Dasiglucagon in Children with Congenital Hyperinsulinism

Published: Feb 15, 2022 | Tags: Zealand Pharma, Enrollment, Dasiglucagon, Children, Congenital Hyperinsulinism

Calliditas Reports First Patient Randomization in P-IIb/III (TRANSFORM) Study for Primary Biliary Cholangitis

Published: Feb 15, 2022 | Tags: Calliditas, First Patient Randomization, P-IIb/III, TRANSFORM Study, Primary Biliary Cholangitis

AffaMed to Initiate P-I Study of AM712 for the Treatment of Retinal Vascular Diseases

Published: Feb 15, 2022 | Tags: AffaMed, AM712, Retinal Vascular Diseases, AMD, AskGene, Japan, Asia

Collegium to Acquire BioDelivery Sciences for ~ $604M

Published: Feb 15, 2022 | Tags: Collegium, Acquire, BioDelivery Sciences, Belbuca, Symproic, Elyxyb

Roivant Launches New Vant to Develop Eisai’s RVT-2001 for Myelodysplastic Syndromes

Published: Feb 15, 2022 | Tags: Roivant, New Vant, Eisai, RVT-2001, Myelodysplastic Syndromes, MDS, Hemavant

Bavarian Nordic’s MVA-BN RSV Receives the US FDA’s Breakthrough Therapy Designation for Prevention of Respiratory Syncytial Virus

Published: Feb 14, 2022 | Tags: Bavarian Nordic, MVA-BN RSV, US, FDA, Breakthrough Therapy Designation, Respiratory Syncytial Virus

Shanghai Public Health Clinical Center Initiated Functional Cure Study Evaluating ASC22 + Chidamide for Patients with HIV

Published: Feb 14, 2022 | Tags: Shanghai Public Health Clinical Center, Functional Cure Study, ASC22, Chidamide, HIV

IASO Bio and Innovent’s CT103A/ IBI326 Receive the US FDA’s Orphan Drug Designation for Multiple Myeloma

Published: Feb 14, 2022 | Tags: IASO Bio, Innovent, CT103A, IBI326, US, FDA, Orphan Drug Designation, Multiple Myeloma

Lilly's Bebtelovimab Receives the US FDA’s EUA for Mild-to-Moderate COVID-19

Published: Feb 14, 2022 | Tags: Lilly, Bebtelovimab, US, FDA, EUA,  Mild, Moderate, COVID-19

Pfizer and BioNTech Delay FDA Request to Expand COVID-19 Vaccine in Children Under 5 Years of Age

Published: Feb 14, 2022 | Tags: Pfizer, BioNTech, Delay, FDA, COVID-19 Vaccine

ProQR’s Sepofarsen Failed to Meet its Primary Endpoint in P-II/III Illuminate Study for CEP290-mediated

Published: Feb 14, 2022 | Tags: ProQR, Sepofarsen, Illuminate, CEP290-mediated LCA10

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