PharmaShots Weekly Snapshots (June 20

Sanofi and GSK Report Results of COVID-19 Vaccine in the P-III (VAT08) Trial Against Omicron

Published: June 24, 2022 | Tags: Sanofi, GSK, COVID-19 Vaccine, Omicron, Clinical Trial, P-III, VAT08 Trial

Argenx Receives CHMP Positive Opinion of Efgartigimod as an Add-on to Standard Therapy for Generalized Myasthenia Gravis

Published: June 24, 2022 | Tags: argenx, CHMP, Efgartigimod, Generalized Myasthenia Gravis

AstraZeneca’s Enhertu Receives Health Canada’s Approval for Expanded Indication in Adults with HER2-Positive Metastatic Breast Cancer

Published: June 24, 2022 | Tags: AstraZeneca, Enhertu, HER2-Positive, Metastatic Breast Cancer, Health Canada, Approval

Astellas Reports the Submission of NDA to the US FDA for Fezolinetant to Treat Vasomotor Symptoms Associated with Menopause

Published: June 24, 2022 | Tags: Astellas, Fezolinetant, Vasomotor Symptoms, Menopause, Regulatory, NDA, US, FDA

Gilead Presents 48 Week Results of Hepcludex (bulevirtide) in P-III (MYR301) Trial for the Treatment of Chronic Hepatitis Delta Virus at ILC 2022

Published: June 24, 2022 | Tags: Gilead, Hepcludex, bulevirtide,, Chronic Hepatitis Delta Virus, P-III MYR301 Trial, ILC, 2022

invoX Pharma to Acquire F-star Therapeutics for ~$161M

Published: June 24, 2022 | Tags: invoX Pharma, F-star Therapeutics, Cancers, M&A, Acquire, ~$161M, Tetravalent (2+2) Bispecific Ab Platform

uniQure Provides Update on Low-Dose Cohort in P-I/II Clinical Trial of AMT-130 for the Treatment of Huntington’s Disease

Published: June 23, 2022 | Tags: uniQure, AMT-130, Huntington’s Disease, Clinical Trials, Low-Dose Cohort, P-I/II Clinical Trial

Apellis Expands its 2018 R&D Collaboration with Affilogic to Develop Nanofitins-Based Therapies for Neurological Diseases

Published: June 23, 2022 | Tags: Apellis, Affilogic, Nanofitins-Based Therapies, Neurological Diseases , Pharma, APL-1030, APL-2006

Zynerba Reports Results of Zygel in P-II (INSPIRE) Trial for the Treatment of Patients with 22q11.2 Deletion Syndrome

Published: June 23, 2022 | Tags: Zynerba, Zygel, with 22q11.2 Deletion Syndrome, Clinical Trials, P-II INSPIRE Trial

BridgeBio Reports Results of BBP-812 in the P-I/II (CANaspire) Trial for the Treatment of Canavan Disease

Published: June 23, 2022 | Tags: BridgeBio, BBP-812, Canavan Disease, Clinical Trial, P-I/II, CANaspire Trial

Aveo Entered into an Clinical Trial Collaboration and Supply Agreement with Eli Lilly to Evaluate Ficlatuzumab + Erbitux (cetuximab) for HNSCC in North America

Published: June 23, 2022 | Tags: Aveo, Eli Lilly, Ficlatuzumab, Erbitux, cetuximab, HNSCC, Pharma, North America

Pasithea Therapeutics Acquires Alpha-5 Integrin for ~$3.75M to Treat ALS and Other Neurological Diseases

Published: June 23, 2022 | Tags: Pasithea Therapeutics, Alpha-5 Integrin, ALS, Neurological, M&A, ~$3.75M

Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Receives the US FDA’s Approval for the Prevention of Invasive Pneumococcal Disease

Published: June 23, 2022 | Tags: Merck, Vaxneuvance, pneumococcal 15-valent conjugate vaccine, Invasive Pneumococcal Disease, US, FDA, Approval

Galderma Reports Results of Nemolizumab in P-III (OLYMPIA 2) Trial for the Treatment of Prurigo Nodularis

Published: June 22, 2022 | Tags: Galderma, Nemolizumab, P-III, OLYMPIA 2 Trial, Prurigo Nodularis

Inivata and Collaborators Report Results of RaDaR MRD Test in (CHiRP) Study for the Treatment of Breast Cancer

Published: June 22, 2022 | Tags: Inivata, RaDaR MRD Test, CHiRP Study, Breast Cancer

Acer Therapeutics and Relief Receive the US FDA’s CRL for ACER-001’s NDA to Treat Urea Cycle Disorders

Published: June 22, 2022 | Tags: Acer Therapeutics, Relief, US, FDA, CRL, ACER-001, NDA, Urea Cycle Disorders

Galapagos to Acquire CellPoint and AboundBio to Advance Cell Therapies for the Treatment of Advanced Cancer

Published: June 22, 2022 | Tags: Galapagos, Acquire, CellPoint, AboundBio, Cell Therapies, Advanced Cancer

Precision Signs Multiple Agreements with Novartis to Develop an In Vivo Gene Editing Therapies for Sickle Cell Disease and Beta Thalassemia

Published: June 22, 2022 | Tags: Precision BioSciences, In Vivo, Gene Editing, Novartis, Sickle Cell Disease, Beta Thalassemia

Ionis Reports 35 Week Interim Analysis of Eplontersen in P-III (NEURO-TTRansform) Study for Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

Published: June 21, 2022 | Tags: Ionis, Eplontersen, P-III, NEURO-TTRansform Study, Hereditary, Transthyretin-Mediated, Amyloid Polyneuropathy

The EC Opens Antitrust Investigation Against Vifor Pharma’s Anti-Competitive Disparagement for Iron Deficiency Treatment

Published: June 21, 2022 | Tags: EC, Antitrust Investigation, Vifor Pharma, Anti-Competitive Disparagement, Iron Deficiency

Oxford BioDynamics Launches EpiSwitch CiRT Blood Test for the Treatment of Cancer in the UK

Published: June 21, 2022 | Tags: Oxford BioDynamics, EpiSwitch CiRT Blood Test, Cancer, UK

Edgewise Therapeutics Reports 2-Month Interim Results of EDG-5506 in P-Ib (ARCH) Study for the Treatment of Becker Muscular Dystrophy

Published: June 21, 2022 | Tags: Edgewise Therapeutics, EDG-5506, Becker Muscular Dystrophy, P-Ib, ARCH Study

Pfizer-BioNTech’s COVID-19 Vaccine Receive the US FDA’s EUA for COVID-19 in Children Aged 6 Months through 4 Years of Age

Published: June 21, 2022 | Tags: Pfizer-BioNTech, COVID-19 Vaccine, US, FDA, EUA, COVID-19

Innovent and Lilly Receive the NMPA’s Approval for Tyvyt (sintilimab) sNDA as 1L Treatment for Esophageal Squamous Cell Carcinoma

Published: June 21, 2022 | Tags: Innovent, Lilly, Tyvyt, sintilimab, Esophageal Squamous Cell Carcinoma, NMPA, Approval

Novartis Publishes Results from Two and Three-Copy Cohorts of Zolgensma in P-III (SPR1NT) Trial for Spinal Muscular Atrophy in the Nature Medicine

Published: June 20, 2022 | Tags: Novartis, Zolgensma, Spinal Muscular Atrophy, P-III, SPR1NT Trial, Nature Medicine