PharmaShots Weekly Snapshots (August 09 – 13, 2021)

Junshi and Coherus’s Toripalimab Receive the US FDA’s Breakthrough Therapy Designation as 1L Treatment of Nasopharyngeal Carcinoma

Published: Aug 13, 2021 | Tags: Junshi, Coherus, Toripalimab, US, FDA, Breakthrough Therapy Designation, Nasopharyngeal Carcinoma

Celltrion’s Regdanvimab (CT-P59) Receives the ANVISA’s EUA for the Treatment of COVID-19 in Brazil

Published: Aug 13, 2021 | Tags: Celltrion, Regdanvimab, CT-P59, ANVISA, EUA, COVID-19, Brazil

Ipsen Reports the Withdrawal of NDA for Palovarotene to Treat Fibrodysplasia Ossificans Progressiva

Published: Aug 13, 2021 | Tags: Ipsen, Withdrawal, NDA, Palovarotene, Fibrodysplasia Ossificans Progressiva

Wise and NYU Langone Health Publish the Results of Personal Zen App for Multiple Sclerosis in Frontiers in Neurology

Published: Aug 13, 2021 | Tags: Wise, NYU Langone Health, Personal Zen App, Clinical Study, Multiple Sclerosis, Frontiers, Neurology

Aprea Reports the FDA’s Hold on Clinical Trials for the Treatment Lymphoid Malignancy

Published: Aug 13, 2021 | Tags: Aprea, FDA, Partial Hold, Clinical Trials, Lymphoid Malignancy

Jazz’ Xywav Receives the US FDA’s Approval for the Treatment of Idiopathic Hypersomnia

Published: Aug 13, 2021 | Tags: Jazz, Xywav, US, FDA, Approval, Idiopathic Hypersomnia

GC Publishes the Results of GC5107 in P-III Trial for the Treatment of Primary Immunodeficiency in Frontiers in Immunology

Published: Aug 12, 2021 | Tags: GC, GC5107, P-III, Trial, Primary Immunodeficiency, Frontiers, Immunology

I-Mab Reports Interim Data of Plonmarlimab (TJM2) in P-II/III Study to Treat COVID-19

Published: Aug 12, 2021 | Tags: I-Mab, Plonmarlimab, TJM2, P-II/III, Study, COVID-19

Innovent’s IBI306 Meets its Primary Endpoint in P-III CREDIT-2 Study for Heterozygous Familial Hypercholesterolemia

Published: Aug 12, 2021 | Tags: Innovent, IBI306, P-III, CREDIT-2 Study, Heterozygous Familial Hypercholesterolemia

C4T’s CFT7455 Receives the US FDA’s Orphan Drug designation for the Treatment of Multiple Myeloma

Published: Aug 12, 2021 | Tags: C4T, CFT7455, US, FDA, Orphan Drug designation, Multiple Myeloma

Merck’s Keytruda (pembrolizumab) + Lenvima (lenvatinib) Receive the US FDA’s Approval as 1L Treatment of Advanced Renal Cell Carcinoma

Published: Aug 12, 2021 | Tags: Merck, Eisai, Keytruda, pembrolizumab, Lenvima, Lenvatinib, US, FDA, Approval, Advanced Renal Cell Carcinoma

Sorrento to License Dyadic’s DYAI-100 and C1 Technology for Protein-Based Coronavirus Vaccines and Therapeutics

Published: Aug 12, 2021 | Tags: Sorrento, Dyadic, DYAI-100, Protein-Based Coronavirus Vaccines, Therapeutics

The US FDA’s Rejects FibroGen’s Roxadustat for the Treatment of Anemia Due to CKD

Published: Aug 11, 2021 | Tags: US, FDA, Reject, FibroGen, Roxadusta, Anemia, CKD

Boston’s EXALT Model B Single-Use Bronchoscope Receives the US FDA’s Clearance for Bronchoscopy Procedures

Published: Aug 11, 2021 | Tags: Boston, EXALT Model B Single-Use Bronchoscope, US, FDA, Clearance, Bronchoscopy Procedures

Merck Reports the US FDA’s Acceptance of Keytruda’s sBLA for Review to Treat MSI-H/dMMR Advanced Endometrial Carcinoma

Published: Aug 11, 2021 | Tags: Merck, US, FDA, Keytruda, sBLA, MSI-H/dMMR, Advanced Endometrial Carcinoma

GW’s Epidyolex (cannabidiol) Receives MHRA’s Approval for the Treatment of Seizures Associated with Tuberous Sclerosis Complex in UK

Published: Aug 11, 2021 | Tags: GW, Epidyolex, cannabidiol, MHRA, Approval, Seizures, Tuberous Sclerosis Complex

Dermavant Reports the US FDA’s Acceptance of NDA for Tapinarof Cream to Treat Plaque Psoriasis

Published: Aug 11, 2021 | Tags: Dermavant, US, FDA, Acceptance, NDA, Tapinarof Cream, Plaque Psoriasis

Takeda to Advance FIN-524 Development Program in Ulcerative Colitis

Published: Aug 11, 2021 | Tags: Takeda, FIN-524 Development Program, Ulcerative Colitis

Merck Reports the US FDA’s Acceptance of sBLA and Priority Review for Keytruda (pembrolizumab) as an Adjuvant Treatment for RCC

Published: Aug 10, 2021 | Tags: Merck, US, FDA, sBLA, Priority Review, Keytruda, pembrolizumab, RCC

Alnylam Reports Completion of Patient Enrollment in P-III HELIOS-B Study for Vutrisiran to Treat ATTR Amyloidosis with Cardiomyopathy

Published: Aug 10, 2021 | Tags: Alnylam, P-III, HELIOS-B Study, Vutrisiran, ATTR Amyloidosis, Cardiomyopathy

Seagen Signs an Exclusive WW License Agreement with RemeGen to Develop and Commercialize Disitamab Vedotin

Published: Aug 10, 2021 | Tags: Seagen, RemeGen, Develop, Commercialize, Disitamab Vedotin

AbbVie Receives $20M Milestone in its DUB Targets Collaboration with Mission to Treat Alzheimer and Parkinson Diseases

Published: Aug 10, 2021 | Tags: AbbVie, 20M Milestones, Mission, DUB Targets, Alzheimer, Parkinson Diseases

Harmony Acquires ConSynance’s Asset for the Treatment of Narcolepsy and other Rare Neurological Diseases

Published: Aug 10, 2021 | Tags: Harmony, ConSynance, Asset, Narcolepsy, Rare Neurological Diseases

AbbVie Terminates its License Agreement with Molecular Partners for Abicipar Pegol

Published: Aug 10, 2021 | Tags: AbbVie, Terminates, License Agreement, Molecular Partners, Abicipar Pegol

Calliditas Receives the US FDA’s Fast Track Designation for Setanaxib to Treat Primary Biliary Cholangitis

Published: Aug 9, 2021 | Tags: Calliditas, US, FDA, Fast Track Designation, Setanaxib, Primary Biliary Cholangitis

UCB Presents Two-Year Data of Bimekizumab in BE BRIGHT Trial for the Treatment of Moderate to Severe Plaque Psoriasis at AAD 2021

Published: Aug 9, 2021 | Tags: UCB, Bimekizumab, BE BRIGHT Trial, Plaque Psoriasis, AAD 2021

Genentech Reports Results of Polivy (polatuzumab vedotin-piiq) + R-CHP in P-III POLARIX Trial for the Treatment of Diffuse Large B-Cell Lymphoma

Published: Aug 9, 2021 | Tags: Genentech, Polivy, polatuzumab vedotin-piiq, R-CHP, P-III, POLARIX Trial, DLBCL

AstraZeneca’s Forxiga (dapagliflozin) Receives EC’s Approval for the Treatment of Chronic Kidney Disease in Patients with and without T2D

Published: Aug 9, 2021 | Tags: AstraZeneca, Forxiga, dapagliflozin, EC, Approval, Chronic Kidney Disease

Eli Lilly and Innovent Report Results of Sintilimab + CT in P-III ORIENT-11 Study as 1L Treatment of NSCLC

Published: Aug 9, 2021 | Tags: Eli Lilly, Innovent, Sintilimab, CT, P-III, ORIENT-11 Study, Non-Squamous NSCLC, Thoracic Oncology

Sanofi’s Nexviazyme (avalglucosidase alfa-ngpt) Receives the US FDA’s Approval for the Treatment of Late-Onset Pompe Disease

Published: Aug 9, 2021 | Tags: Sanofi, Nexviazyme, avalglucosidase alfa-ngpt, Receives, US, FDA, Approval, Late-Onset Pompe Disease

Related Post: PharmaShots Weekly Snapshots (Aug 02 – 06, 2021)