Novartis’ Cosentyx Receives the US FDA’s Approval to Treat Enthesitis-Related Arthritis and Psoriatic Arthritis

Published: Dec 23, 2021 | Tags: Novartis, Cosentyx, US FDA, Enthesitis-Related Arthritis, Psoriatic Arthritis, Sensoready, US, China

Gilead Reports Full Results from a P-III Investigational Study of Veklury (remdesivir) for the Treatment of COVID-19

Published: Dec 23, 2021 | Tags: Gilead, Veklury, Remdesivir, COVID-19, P-III, PINETREE Study, IND, US, FDA

DURECT Corporation Enters a $136M Licensing Agreement with Innocoll Biotherapeutics for Posimir (Bupivacaine Solution)

Published: Dec 23, 2021 | Tags: DURECT, Innocoll, Posimir, Bupivacaine Solution, US, Commercial Licensing Agreement

Aerogen Pharma Enters an Exclusive Agreement with Nuance Pharma to Advance Treatment of Respiratory Distress Syndrome in Premature Infants in China

Published: Dec 23, 2021 | Tags: Aerogen Pharma, Nuance Pharma, Respiratory Distress Syndrome, AeroFact, Alveofact, Nasal Delivery System, China

Akeso and Dawnrays Biotechnology’s Ebronucimab (PCSK9 mAb) Reports Early Completion of Patient Enrollment in P-III Trial for Primary Hypercholesterolemia and Mixed Hyperlipidemia

Published: Dec 23, 2021 | Tags: Akeso, Dawnrays Biotechnology, Ebronucimab, PCSK9 mAb, P-III Trial, Hypercholesterolemia, Mixed Hyperlipidemia

Pfizer Receives the US FDA Emergency Use Authorization for Paxlovid to Treat Mild-to-Moderate COVID-19 in Adults and Pediatric Patients

Published: Dec 23, 2021 | Tags: Pfizer, US FDA, Emergency Use Authorization, Paxlovid, COVID-19, EPIC-HR study, Nirmatrelvir, Ritonavir

Pfizer Reports Five-Year Follow-Up Data of Vyndaqel/Vyndamax in P-III (ATTR-ACT) Trial for Transthyretin Amyloid Cardiomyopathy

Published: Dec 22, 2021 | Tags: Pfizer, Vyndaqel, Vyndamax, P-III, ATTR-ACT Trial, Transthyretin Amyloid Cardiomyopathy

Novartis to Acquire Gyroscope Therapeutics for Ocular Gene Therapy to Treat Geographic Atrophy

Published: Dec 22, 2021 | Tags: Novartis, Acquire, Gyroscope Therapeutics, Ocular Gene Therapy, Geographic Atrophy

Gilead Reports the US FDA's Clinical Hold of Lenacapavir for the Treatment of HIV

Published: Dec 22, 2021 | Tags: Gilead, US, FDA, Clinical Hold, Lenacapavir, HIV

Novaliq Reports Results of CyclASol in P-III (ESSENCE-2) Trial for the Treatment of Dry Eye Disease

Published: Dec 22, 2021 | Tags: Novaliq, CyclASol, P-III, ESSENCE-2 Trial, Dry Eye Disease

GSK Expands its Collaboration with Ligand to Develop Genetically-Validated Targets for Neurological Diseases Gilead, US, FDA, Clinical Hold, Lenacapavir, HIV

Published: Dec 22, 2021 | Tags: GSK, Ligand, Genetically-Validated, Targets, Neurological Diseases

Karyopharm Signs an Exclusive License Agreement with Menarini to Commercialize Nexpovio (selinexor) for Oncology

Published: Dec 22, 2021 | Tags: Karyopharm, Menarini, Nexpovio, Selinexor, Oncology

Gilead’s Veklury (remdesivir) Receives EC’s Approval for the Treatment of COVID-19

Published: Dec 21, 2021 | Tags: Gilead, Veklury, remdesivir, EC, Approval, COVID-19

Lilly Reports Results of Lebrikizumab in P-III (Adhere) Trial for the Treatment of Atopic Dermatitis

Published: Dec 21, 2021 | Tags: Lilly, Lebrikizumab, P-III, Adhere Trial, Atopic Dermatitis

Sanofi to Acquire Amunix for Transformative T-Cell Engagers and Cytokine Therapies to Treat Cancer

Published: Dec 21, 2021 | Tags: Sanofi, Acquire, Amunix, Transformative T-Cell Engagers, Cytokine Therapies, Cancer

ViiV Healthcare’s Apretude (cabotegravir) Receives US FDA’s Approval for the Prevention of HIV

Published: Dec 21, 2021 | Tags: ViiV Healthcare, Apretude, cabotegravir, US, FDA, Approval, HIV

Cytokinetics Expands its Collaboration with Ji Xing to Develop and Commercialize Omecamtiv Mecarbil for HFrEF in Greater China

Published: Dec 21, 2021 | Tags: Cytokinetics, Ji Xing, Omecamtiv Mecarbil, HFrEF, Greater China

Novartis Signs a Multiple Agreement with BeiGene for Ociperlimab to Treat Solid Tumor

Published: Dec 21, 2021 | Tags: Novartis, BeiGene, Ociperlimab, Solid Tumor

Lineage Signs an Exclusive WW Agreement with Genentech to Develop and Commercialize OpRegen RPE Cell Therapy for the Treatment of Ocular Disorders

Published: Dec 20, 2021 | Tags: Lineage, Genentech, OpRegen RPE Cell Therapy, Ocular Disorders

Novartis Reports Update of ligelizumab (QGE031) in P-III PEARL 1 & 2 Studies for the Treatment of Chronic Spontaneous Urticaria

Published: Dec 20, 2021 | Tags: Novartis, Ligelizumab, QGE031, P-III, PEARL 1, 2, Studies, Chronic Spontaneous Urticaria

Bluebird bio Reports US FDA Acceptance of BLA for Priority Review of Lenti-D (elivaldogene autotemcel) for Cerebral Adrenoleukodystrophy

Published: Dec 20, 2021 | Tags: bluebird bio, US, FDA, BLA, Priority Review, Lenti-D, elivaldogene autotemcel, Cerebral Adrenoleukodystrophy

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

Published: Dec 20, 2021 | Tags: GBT, Oxbryta, voxelotor, CHMP, Hemolytic Anemia, Sickle Cell Disease

GSK and Vir’s Xevudy (sotrovimab) Receive EC's Marketing Authorization for the Treatment of COVID-19

Published: Dec 20, 2021 | Tags: GSK, Vir, Xevudy, sotrovimab, EC, Marketing Authorization, COVID-19

Janssen Signs a Multiple Agreement with Dyadic to Manufacture Therapeutic Protein Candidates Using C1 Platform

Published: Dec 20, 2021 | Tags: Janssen, Dyadic, Therapeutic Protein Candidates, C1 Platform

Related Post: PharmaShots Weekly Snapshots (December 13 - 17, 2021)