PharmaShots Weekly Snapshots (July 12 – 16, 2021)

Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease

Published: July 16, 2021 | Tags: Eli Lilly, Banner Alzheimer’s Institute, Donanemab, P-III, TRAILBLAZER-ALZ 3 Trial, Alzheimer Disease

AcelRx Signs a License Agreement with Aguettant to Commercialize Dzuveo in EU and for Two Pre-Filled Syringe Products in US

Published: July 16, 2021 | Tags: AcelRx, License Agreement, Aguettant, Dzuveo, EU, Pre-Filled Syringe Products, US

Bio-Thera Reports First Patient Dosing in P-III Study for BAT2206 Proposed Biosimilar of Stelara (ustekinumab)

Published: July 16, 2021 | Tags: Bio-Thera, P-III, BAT2206, Proposed Biosimilar, Stelara, Ustekinumab

Vir Reports First Patient Dosing in P-II MARCH Trial for VIR-2218 + VIR-3434 as a Functional Cure Regimen for Chronic Hepatitis B Virus Infection

Published: July 16, 2021 | Tags: Vir, P-II, MARCH Trial, VIR-2218, VIR-3434, Functional Cure Regimen, Chronic Hepatitis B Virus Infection

Alexion Reports Results of Ultomiris (ravulizumab-cwvz) in P-III Study for Generalized Myasthenia Gravis

Published: July 16, 2021 | Tags: Alexion, Ultomiris, ravulizumab-cwvz, P-III, Study, Generalized Myasthenia Gravis

Ipsen Signs an Exclusive WW License Agreement with IRLAB for Mesdopetam to Treat Parkinson Disease

Published: July 16, 2021 | Tags: Ipsen, License Agreement, IRLAB, Mesdopetam, Parkinson Disease

Skyhawk Collaborate with Aragen to Develop Novel Small Molecule Therapeutics to Correct RNA Expression

Published: July 15, 2021 | Tags: Skyhawk, Aragen, Develop, Novel Small Molecule Therapeutics

Heat Biologics Signs a Research License Agreement with ProBioGen for Transposase System and Suspension HEK293 Cell Line

Published: July 15, 2021 | Tags: Heat Biologics, ProBioGen, Transposase System, Suspension, HEK293 Cell Line

Johnson & Johnson Publishes Interim Results of Single-Shot COVID-19 Vaccine in P-I/IIa Sub-Study for COVID 19 in NEJM

Published: July 15, 2021 | Tags: Johnson & Johnson, Single-Shot COVID-19 Vaccine, P-I/IIa, Sub-Study, COVID 19, NEJM

Incyte and Novartis Publish Results of Jakafi (ruxolitinib) in P-III REACH3 Study to Treat Chronic Graft-Versus-Host Disease in NEJM

Published: July 15, 2021 | Tags: Novartis, Incyte, Jakafi, ruxolitinib, P-III, REACH3 Study, Chronic Graft-Versus-Host Disease, NEJM

Galapagos Reports Results of GLPG3667 in P-Ib Study for the Treatment of Psoriasis

Published: July 15, 2021 | Tags: Galapagos, GLPG3667, P-Ib, Study, Psoriasis

Eli Lilly to Acquire Protomer Technologies for ~$1B

Published: July 15, 2021 | Tags: Eli Lilly, Acquire, Protomer Technologies, ~$1B

Caribou Reports the First Patient Dosing in P-I ANTLER Study of CB-010 to Treat Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Published: July 14, 2021 | Tags: Caribou, First Patient Dosing, P-I, ANTLER Trial, CB-010, B- Cell Non-Hodgkin Lymphoma

Strongbridge Reports Results of Post Hoc Analyses from a One Year HYPHOP Study of Keveyis (dichlorphenamide) to Treat Primary Periodic Paralysis

Published: July 14, 2021 | Tags: Strongbridge, Post Hoc Analyses, One Year, HYPHOP Study, Keveyis, dichlorphenamide, Primary Periodic Paralysis

Astellas Signs a License Agreement with ExCellThera for In Vitro Use of UM171 in Pluripotent Stem Cells

Published: July 14, 2021 | Tags: Astellas, License Agreement, ExCellThera, In Vitro, UM171, Pluripotent Stem Cells

Ionis Signs an Exclusive WW License Agreement with Bicycle to Develop Targeted Oligonucleotide Therapeutics Using TfR1 Bicycle Technology

Published: July 14, 2021 | Tags: Ionis, Exclusive License Agreement, Bicycle, Targeted Oligonucleotide Therapeutics, TfR1 Bicycle Technology

Hologic Receives CE Mark to Use Saliva Samples with Aptima SARS-CoV-2 Test in EU

Published: July 14, 2021 | Tags: Hologic, CE Mark, Saliva Samples, Aptima SARS-CoV-2 Test, EU

Hepion Reports Results of CRV431 in P-IIa AMBITION Trial for the Treatment of NASH

Published: July 14, 2021 | Tags: Hepion, CRV431, P-IIa, AMBITION Trial, NASH

Astellas and Affinivax Present Results of ASP3772 in P-II Study for Streptococcus Pneumoniae

Published: July 13, 2021 | Tags: Astellas, Affinivax, ASP3772, P-II, Study, Streptococcus pneumoniae

Hutchmed Reports First Commercial Sale of Orpathys (savolitinib) in China

Published: July 13, 2021 | Tags: Hutchmed, First Commercial Sale, Orpathys, savolitinib, China

Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) + Pomalidomide and Dexamethasone Receive the US FDA’s Approval to Treat Patients with Multiple Myeloma

Published: July 13, 2021 | Tags: Janssen, Darzalex Faspro, daratumumab, hyaluronidase-fihj, Pomalidomide, Dexamethasone, US, FDA, Approval, Multiple Myeloma

Menagen Signs a Commercialization Agreement with CKD for Biosimilar Darbepotein Alfa

Published: July 13, 2021 | Tags: Menagen, Commercialization Agreement, CKD, Biosimilar Darbepotein Alfa

Biogen Signs a License Agreement with Innocare for Orelabrutinib to Treat Multiple Sclerosis

Published: July 13, 2021 | Tags: Biogen, License Agreement, Innocare, Orelabrutinib, Multiple Sclerosis

Novo Nordisk to Acquire Prothena’s ATTR Amyloidosis Program for ~$1.2B

Published: July 13, 2021 | Tags: Novo Nordisk, Acquire, Prothena, ATTR Amyloidosis Programme, $1.2B

Janssen Presents Three-Year Data of Stelara (ustekinumab) in P-lll UNIFI LTE Study for the Treatment of Moderately to Severely Active Ulcerative Colitis at ECCO

Published: July 12, 2021 | Tags: Janssen, Stelara, ustekinumab, P-lll, UNIFI LTE Study, Active Ulcerative Colitis

Galapagos Reports New Post-Hoc Analyses from P-III SELECTION Program of Filgotinib to Treat Ulcerative Colitis

Published: July 12, 2021 | Tags: Galapagos, P-III, SELECTION Trials, Filgotinib, Ulcerative Colitis, UC

Innovent Reports First Patient Dosing in P-I CIBI323A101 Study of IBI323 to Treat Advanced Malignant Tumors

Published: July 12, 2021 | Tags: Innovent, P-I, CIBI323A101 Study, IBI323, Advanced Malignant Tumors

Astellas and Seagen’s Padcev (enfortumab vedotin-ejfv) Receive the US FDA’s Full Approval and Expands Indication for Patients with Locally Advanced or Metastatic Urothelial Cancer

Published: July 12, 2021 | Tags: Astellas, Seagen, Padcev, enfortumab vedotin-ejfv, US, FDA, Regular Approval, Locally Advanced, Metastatic Urothelial Cancer

Takeda Presents Results of Takhzyro (lanadelumab) in P-III HELP Study Open-Label Extension to Treat Hereditary Angioedema Attacks at EAACI 2021

Published: July 12, 2021 | Tags: Takeda, Takhzyro, lanadelumab, P-III, HELP Study, Open-Label Extension, Hereditary Angioedema Attacks, EAACI 2021

Bayer’s Kerendia (finerenone) Receives the US FDA’s Approval for the Treatment of Chronic Kidney Disease Associated with Type 2 Diabetes

Published: July 12, 2021 | Tags: Bayer, Kerendia, finerenone, US, FDA, Approval, Chronic Kidney Disease, Type 2 Diabetes

Related Post: PharmaShots Weekly Snapshots (July 05 – 09, 2021)

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