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PharmaShots Weekly Snapshots (June 20 – 24, 2022)

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PharmaShots Weekly Snapshots (June 20 – 24, 2022)

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

BMS Reports EMA's Validation of Type II Variation Application for Breyanzi (lisocabtagene maraleucel) to Treat R/R Large B-cell Lymphoma

Published: June 20, 2022 | Tags: BMS, Breyanzi, lisocabtagene maraleucel, Large B-cell Lymphoma , EMA, Type II Variation Application

Myovant and Pfizer Report Result of Relugolix Combination Therapy in P-III (SPIRIT 1 & 2) Studies for Endometriosis-Associated Pain

Published: June 20, 2022 | Tags: Myovant, Pfizer, Relugolix Combination Therapy, Endometriosis,  Pain, P-III, SPIRIT 1 & 2 Studies

AbbVie’s Skyrizi (risankizumab-rzaa) Receives the US FDA’s Approval as the First Specific Interleukin-23 to Treat Moderately to Severely Active Crohn's Disease

Published: June 20, 2022 | Tags: AbbVie, Skyrizi, risankizumab-rzaa, Crohn's Disease, US, FDA, Approval

Zura Bio to Go Public via JATT SPAC Merger for ~$215M

Published: June 20, 2022 | Tags: Zura Bio, Public, JATT, SPAC Merger, ~$215M, ZB-168

ObsEva’s Yselty (linzagolix) Receive EC's Marketing Authorization for the Treatment of Uterine Fibroids

Published: June 20, 2022 | Tags: ObsEva, Yselty, linzagolix, EC, Marketing Authorization, Uterine Fibroids

Related Post: PharmaShots Weekly Snapshots (June 13– 17, 2022)


Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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