PharmaShots Weekly Snapshots (April 18-22, 2022)

Novavax Initiates NVX-CoV2373 (COVID-19 vaccine booster) in P-III (PREVENT-19) Trial for COVID-19 in Adolescents

Published: Apr 22, 2022 | Tags: Novavax, NVX-CoV2373, COVID-19, Vaccine Booster, P-III, PREVENT-19 Trial, COVID-19, Adolescents

Sanofi Entered into a License Agreement with Terran Biosciences for Two Late-Stage CNS pipeline Assets to Treat Neurological and Psychiatric Indications

Published: Apr 22, 2022 | Tags: Sanofi, Terran Biosciences, CNS Pipeline Assets, Neurological, Psychiatric Indications

Novavax Reports Results of COVID-19-Influenza Vaccine in P-I/II Trial for the Treatment of COVID-19

Published: Apr 22, 2022 | Tags: Novavax, COVID-19-Influenza Vaccine, P-I/II Trial, COVID-19

Orasis Reports Results of CSF-1 in P-III (NEAR-1 & 2) Trials for the Treatment of Presbyopia

Published: Apr 22, 2022 | Tags: Orasis, CSF-1, P-III, NEAR-1 & 2 Trials, Presbyopia

Zambon’s CMS I-neb Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Non-Cystic Fibrosis Bronchiectasis

Published: Apr 22, 2022 | Tags: Zambon, CMS I-neb, US, FDA, Breakthrough Therapy Designation, Non-Cystic Fibrosis Bronchiectasis

Dragonfly Expands its 2019 Collaboration with AbbVie to Develop Novel Therapies for Immune-Mediated Diseases

Published: Apr 22, 2022 | Tags: Dragonfly, 2019, AbbVie, Therapies, Immune-Mediated Diseases

Servier Publishes Results of Tibsovo (ivosidenib) in P-III (AGILE) Trial for IDH1-Mutated Acute Myeloid Leukemia in NEJM

Published: Apr 21, 2022 | Tags: Servier, Tibsovo, ivosidenib, P-III, AGILE Trial, IDH1-Mutated, Acute Myeloid Leukemia, NEJM

Ultragenyx Reports the First Patient Dosing of Setrusumab (UX143) in P-II/III (Orbit) Study for the Treatment of Osteogenesis Imperfecta

Published: Apr 21, 2022 | Tags: Ultragenyx, Setrusumab, UX143, P-II/III, Orbit Study Osteogenesis Imperfecta

Otonomy Reports Results of OTO-413 in P-IIa Clinical Trial for the Treatment of Hearing Loss

Published: Apr 21, 2022 | Tags: Otonomy, OTO-413, P-IIa, Clinical Trial, Hearing Loss

AstraZeneca Reports Results of Evusheld in P-III (PROVENT) Trial for the Treatment of Symptomatic COVID-19

Published: Apr 21, 2022 | Tags: AstraZeneca, Evusheld, P-III, PROVENT Trial, Symptomatic COVID-19

Vertex Receives the Health Canada Marketing Authorization for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat Cystic Fibrosis

Published: Apr 21, 2022 | Tags: Vertex, Health Canada, Marketing Authorization, Trikafta, elexacaftor, tezacaftor,ivacaftor, Cystic Fibrosis

Boehringer Ingelheim Entered into a Research Agreement with VantAI to Identify Novel Protein Degraders

Published: Apr 21, 2022 | Tags: VantAI, Boehringer Ingelheim, Novel Protein Degraders, Geometric Deep Learning Platform

AlloVir’s Posoleucel Receives the US FDA’s RMAT Designation for Prevention of Multiple Infections from 6 Viruses in Patient with Allogeneic Hematopoietic Cell Transplant

Published: Apr 20, 2022 | Tags: AlloVir, Posoleucel, US, FDA, RMAT, Designation, Allogeneic Hematopoietic Cell Transplant

Idorsia Launches Pivlaz (clazosentan) for the Treatment of Aneurysmal Subarachnoid Hemorrhage in Japan

Published: Apr 20, 2022 | Tags: Idorsia, Pivlaz, clazosentan, MHLW, Approval, Aneurysmal Subarachnoid Hemorrhage, Japan

Bavarian Nordic Reports the First Patient Dosing in P-III (VANIR) Trial for the Treatment of Respiratory Syncytial Virus

Published: Apr 20, 2022 | Tags: Bavarian Nordic, P-III, VANIR Trial, Respiratory Syncytial Virus

INmune Bio Reports First Patient Dosing in P-II (XPro1595) Trial for the Treatment of Neuroinflammation in Patients with Alzheimer Disease

Published: Apr 20, 2022 | Tags: INmune Bio, P-II, XPro1595 Trial, Neuroinflammation, Alzheimer Disease

SpringWorks Entered into a Clinical Trial Collaboration and Supply Agreement with Regeneron to Evaluate Nirogacestat + REGN5458 for Multiple Myeloma

Published: Apr 20, 2022 | Tags: SpringWorks, Regeneron, Nirogacestat, REGN5458, Multiple Myeloma

Ono Entered into an Agreement with Domain and Université de Montréal to Discover Small Molecules Targeting G-Protein Coupled Receptors

Published: Apr 20, 2022 | Tags: Ono, Domain, Université de Montréal, Small Molecules, G-Protein Coupled Receptors

Neuraly Reports the Completion of Patient Enrollment in P-II Study of NLY01 for the Treatment of Parkinson’s Disease

Published: Apr 19, 2022 | Tags: Neuraly, P-II Study, NLY01, Parkinson’s Disease

BeiGene Provides Updates of Tislelizumab in P-III (RATIONALE-309) Trial as 1L Treatment of Recurrent or Metastatic Nasopharyngeal Cancer Presented at ASCO 2022

Published: Apr 19, 2022 | Tags: BeiGene, Tislelizumab, P-III, RATIONALE-309 Trial, Nasopharyngeal Cancer, ASCO, 2022

Daiichi Sankyo and AstraZeneca Report the US FDA Acceptance for Priority Review of Enhertu to Treat HER2 Mutant Metastatic Non-Small Cell Lung Cancer

Published: Apr 19, 2022 | Tags: Daiichi Sankyo, AstraZeneca, US, FDA, Enhertu, Priority Review, HER2 Mutant, Metastatic, Non-Small Cell Lung Cancer

Takeda’s Nuvaxovid COVID-19 Vaccine Receives the MHLW Approval for the Treatment of COVID-19

Published: Apr 19, 2022 | Tags: Takeda, Nuvaxovid, COVID-19 Vaccine, MHLW, Approval, COVID-19

Amgen Reports Results of ABP 654 (biosimilar, ustekinumab) in P-III Study for the Treatment of Plaque Psoriasis

Published: Apr 19, 2022 | Tags: Amgen, ABP 654, biosimilar, ustekinumab, P-III Study, Plaque Psoriasis

Biocytogen Entered into an Agreement with CtM Biotech to Co-develop TCR-Mimic Antibody-Based Multi-Specific T Cell Engagers for Cancer

Published: Apr 19, 2022 | Tags: Biocytogen, CtM Biotech, TCR-Mimic, Antibody-Based, Multi-Specific, T Cell, Engagers, Cancer

Black Diamond Report First Patient Dosing in a P-I Study of BDTX-1535 for Glioblastoma and Non-Small Cell Lung Cancer

Published: Apr 18, 2022 | Tags: Black Diamond, First Patient Dosing, P-I Study, BDTX-1535, Glioblastoma, Non-Small Cell Lung Cancer

Evelo Reports the Clinical Hold on EDP1867 Program for the Treatment of Atopic Dermatitis

Published: Apr 18, 2022 | Tags: Evelo, Clinical Hold, EDP1867, Program, Atopic Dermatitis

The US FDA Extends BLA Review for Regeneron’s REGEN-COV for the Treatment and Prophylaxis of COVID-19

Published: Apr 18, 2022 | Tags: US, FDA, BLA, Regeneron, REGEN-COV, COVID-19

The US FDA Approved First Breathalyzer to Detect COVID-19

Published: Apr 18, 2022 | Tags: US, FDA, Approved, Breathalyzer, Detect, COVID-19, EUA, InspectIR

TG Therapeutics Voluntary Withdrawal BLA/sNDA of U2 for Patients with CLL and SLL

Published: Apr 18, 2022 | Tags: TG Therapeutics, Voluntary Withdrawal, BLA, sNDA, U2, CLL, SLL, ublituximab, Ukoniq

BeiGene’s Tislelizumab Receives the NMPA’s Approval as a 2L Treatment for Esophageal Squamous Cell Carcinoma

Published: Apr 18, 2022 | Tags: BeiGene, Tislelizumab, NMPA, Approval, 2L, Esophageal Squamous Cell Carcinoma