PharmaShots Weekly Snapshots (February 28- March 04, 2022)

Amgen’s Lumykras (sotorasib) Receives NICE Recommendation for the Treatment of Non-Small-Cell Lung Cancer

Published: Mar 04, 2022 | Tags: Amgen, Lumykras, sotorasib NICE, Recommendation, Non-Small-Cell Lung Cancer

Fulcrum Seeks to Initiate the P-III (REACH) Trial of Losmapimod for the Treatment of Facioscapulohumeral Muscular Dystrophy

Published: Mar 04, 2022 | Tags: Fulcrum, P-III, REACH Trial, Losmapimod, Facioscapulohumeral Muscular Dystrophy

Aravive Reports Updated Results of Batiraxcept in the P-Ib Study for the Treatment of Clear Cell Renal Cell Carcinoma

Published: Mar 04, 2022 | Tags: Aravive, Batiraxcept, P-Ib Study, Clear Cell Renal Cell Carcinoma

AstraZeneca and Sanofi Publishes Results of Nirsevimab in P-III (MELODY) Trial for the Treatment of RSV in the NEJM

Published: Mar 04, 2022 | Tags: AstraZeneca, Sanofi, Nirsevimab, P-III, MELODY Trial, RSV, NEJM

BeiGene’s Brukinsa (zanubrutinib) Receives the Health Canada Approval for the Treatment of Marginal Zone Lymphoma

Published: Mar 04, 2022 | Tags: BeiGene, Brukinsa, zanubrutinib, Health Canada, Approval, Marginal Zone Lymphoma

Aquestive Entered into a License, Development & Supply Agreement with Haisco to Develop and Commercialize Exservan (riluzole oral film) for ALS in China

Published: Mar 04, 2022 | Tags: Aquestive, Haisco, Exservan, riluzole oral film, ALS, China

Pfizer Receive the US FDA’s Breakthrough Therapy Designation for Respiratory Syncytial Virus Vaccine for the Prevention of RSV

Published: Mar 03, 2022 | Tags: Pfizer, US, FDA, Breakthrough Therapy Designation, Respiratory Syncytial Virus Vaccine, RSV

Lexeo Reports Initial Expression and Biomarker Data of LX1001 in P-I/II Clinical Trial for the Treatment of Alzheimer’s Disease

Published: Mar 03, 2022 | Tags: Lexeo, LX1001, P-I/II, Clinical Trial, Alzheimer’s Disease

SAB Biotherapeutics Discontinues P-III (ACTIV-2) Trial of SAB-185 for the Treatment of COVID-19

Published: Mar 03, 2022 | Tags: SAB Biotherapeutics, P-III, ACTIV-2 Trial, SAB-185, COVID-19

AmMax Bio Reports Results of AMB-05X in P-II POC Study for the Treatment of Tenosynovial Giant Cell Tumor

Published: Mar 03, 2022 | Tags: AmMax Bio, AMB-05X, P-II, POC Study, Tenosynovial Giant Cell Tumor

Novartis Reports Results of Kesimpta (ofatumumab) in P-IIIb (ALITHIOS) OLE Study for the Treatment of Multiple Sclerosis

Published: Mar 03, 2022 | Tags: Novartis, Kesimpta, ofatumumab, P-IIIb, ALITHIOS, OLE Study, Multiple Sclerosis

Oculis Entered into a License Agreement with Accure Therapeutics to Develop and Commercialize ACT-01 for Acute Optic Neuritis and Glaucoma

Published: Mar 03, 2022 | Tags: Oculis, Accure Therapeutics, ACT-01, Acute Optic Neuritis, Glaucoma

Adagene Entered into an Exclusive License Agreement with Sanofi to Develop Novel Masked Immuno-Oncology Antibody

Published: Mar 02, 2022 | Tags: Adagene, Sanofi, Masked Immuno-Oncology Antibody

Medexus Signs a Multiple Agreement with NXDC to Commercialize Gleolan for the Treatment of Glioma in the US

Published: Mar 02, 2022 | Tags: Medexus, NXDC, Gleolan, Glioma, US

Boehringer Ingelheim & Eli Lilly Report Results of Jardiance (empagliflozin) in P-III (EMPULSE) Trial for Acute Heart Failure

Published: Mar 02, 2022 | Tags: Boehringer Ingelheim, Eli Lilly, Jardiance, empagliflozin, P-III, EMPULSE Trial, Acute Heart Failure

Pfizer Reports Results of Clostridioides Difficile Vaccine in P-III (CLOVER) Trial for the Prevention of C. Difficile Infection

Published: Mar 02, 2022 | Tags: Pfizer, Clostridioides Difficile Vaccine, P-III, CLOVER Trial, C. Difficile Infection

Quanterix Entered into a Collaboration with Eli Lilly to Develop Plasma-Based Biomarkers for Alzheimer’s Disease

Published: Mar 02, 2022 | Tags: Quanterix, Eli Lilly, Plasma-Based Biomarkers, Alzheimer’s Disease

AbbVie Acquires Syndesi Therapeutics for ~$1B

Published: Mar 02, 2022 | Tags: AbbVie, Acquires, Syndesi Therapeutics, ~$1B, Neuropsychiatric, Neurodegenerative Disorders, Alzheimer's disease

Legend Biotech’s Carvykti (ciltacabtagene autoleucel) Receives the US FDA’s Approval for the Treatment of Multiple Myeloma

Published: Mar 01, 2022 | Tags: Legend Biotech, Carvykti, ciltacabtagene autoleucel, US, FDA, Approval, Multiple Myeloma

Goldfinch Bio Reports Preliminary Results of GFB-887 in P-II (TRACTION-2) Trial for Focal Segmental Glomerular Sclerosis & Diabetic Nephropathy

Published: Mar 01, 2022 | Tags: Goldfinch Bio, GFB-887, P-II, TRACTION-2 Trial, Focal Segmental Glomerular Sclerosis, Diabetic Nephropathy

Innovent and AnHeart’s Receive NMPA’s Breakthrough Therapy Designation for Taletrectinib to Treat ROS1-Positive Non-Small Cell Lung Cancer

Published: Mar 01, 2022 | Tags: Innovent, AnHeart, NMPA, Breakthrough Therapy Designation, Taletrectinib, ROS1-Positive. Non-Small Cell Lung Cancer

Crinetics Entered into an Exclusive License Agreement with Sanwa Kagaku Kenkyusho to Develop and Commercialize Paltusotine in Japan

Published: Mar 01, 2022 | Tags: Crinetics, Sanwa Kagaku Kenkyusho, Paltusotine, Japan, Acromegaly, Neuroendocrine Tumors

Blueprint Collaborated with Proteovant to Advance Novel Targeted Protein Degrader Therapies

Published: Mar 01, 2022 | Tags: Blueprint, Proteovant, Protein Degrader Therapies

Biocon to Acquire Viatris’ Biosimilars Assets for ~$3.335B

Published: Mar 01, 2022 | Tags: Biocon, Acquire, Viatris, Biosimilars, ~$3.335B

Sanofi to Present the Data from P-III Study of Dupixent at 2022 AAAAI Annual Meeting for the Treatment of Eosinophilic Esophagitis

Published: Feb 28, 2022 | Tags: Sanofi, AAAAI, Dupixent, Eosinophilic Esophagitis

Amgen To Present the New Data from Pivotal P-III (NAVIGATOR) and P-IIb (PATHWAY) Trials of Tezspire at the 2022 AAAAI Annual Meeting

Published: Feb 28, 2022 | Tags: Amgen, AAAAI, NAVIGATOR, PATHWAY, Tezspire

Clarity Pharmaceuticals Reports First Patient Dosing in P-I/IIa Study (CL04) of the 64Cu/67Cu Sartate to Treat Neuroblastoma

Published: Feb 28, 2022 | Tags: Clarity, P-I/IIa Study, CL04, Cu/67Cu Sartate, Neuroblastoma