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PharmaShots Weekly Snapshots (September 05 - 09, 2022)

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PharmaShots Weekly Snapshots (September 05 - 09, 2022)

PharmaShots Weekly Snapshots (September 05 - 09, 2022)

Novartis Reports P-III (MONALEESA-2/3/7) Study Results of Kisqali (ribociclib) for HR+/HER2- Advanced Breast Cancer

Published: Sept 9, 2022 | Tags: Novartis, Kisqali, ribociclib, HR+/HER2- Advanced Breast Cancer, Clinical Trial, P-III MONALEESA-2/3/7 Study

Pfizer Reports the US FDA and EMA's Acceptance of NDA & MAA for Ritlecitinib to Treat Alopecia Areata in Patients Aged ≥12 Years

Published: Sept 9, 2022 | Tags: Pfizer, Ritlecitinib, Alopecia Areata, Regulatory, US, FDA, EMA, NDA, MAA

Abbott Launches Amplatzer Talisman PFO Occlusion System for the Treatment of Patent Foramen Ovale in the EU

Published: Sept 9, 2022 | Tags: Abbott, Amplatzer Talisman PFO Occlusion System, Patent Foramen Ovale, EU, DigiHealth

Regeneron Reports (PHOTON) and (PULSAR) Study Results of Aflibercept for Diabetic Macular Edema and Wet Age-Related Macular Degeneration

Published: Sept 9, 2022 | Tags: Regeneron, Aflibercept, Diabetic Macular Edema, Wet Age-Related Macular Degeneration, Clinical Trial, PHOTON, PULSAR Study

Eli Lilly Presents P-III (ADvocate 1 & 2) Trial Results of Lebrikizumab for the Treatment of Atopic Dermatitis at EADV 2022

Published: Sept 9, 2022 | Tags: Eli Lilly, Lebrikizumab, Atopic Dermatitis, Clinical Trial, P-III ADvocate 1 & 2 Trial, EADV, 2022

SpringWorks Entered into an Expanded Non-Exclusive License Agreement with GSK for Nirogacestat + Blenrep to Treat Multiple Myeloma

Published: Sept 9, 2022 | Tags: SpringWorks, GSK, Nirogacestat, Blenrep, Multiple Myeloma, Pharma

Selexis Signs a Service Agreement with NexImmune to Advance Multiple Immunotherapies for Rare Cancers and Autoimmune Disorders

Published: Sept 8, 2022 | Tags: Selexis, NexImmune, Immunotherapies, Rare Cancers, Autoimmune Disorders, Pharma, SUREtechnology Platform

Brainomix Collaborated with Bridge Biotherapeutics for BBT-877 to Treat Idiopathic Pulmonary Fibrosis Using AI-Powered e-ILD Software

Published: Sept 8, 2022 | Tags: Brainomix, Bridge Biotherapeutics, BBT-877, Idiopathic Pulmonary Fibrosis, AI-Powered e-ILD Software, Pharma

HUTCHMED Presents P-III (FRESCO-2) MRCT Study Results of Fruquintinib for Refractory Metastatic Colorectal Cancer at ESMO 2022

Published: Sept 8, 2022 | Tags: HUTCHMED, Fruquintinib, Refractory Metastatic Colorectal Cancer, Clinical Trial, P-III FRESCO-2 MRCT Study ESMO, 2022

UCB Presents New Three-Year P-III (BE BRIGHT) OLE Study Results of Bimekizumab for Plaque Psoriasis at EADV 2022

Published: Sept 8, 2022 | Tags: UCB, Bimekizumab, Plaque Psoriasis, Clinical Trial, P-III (BE BRIGHT) OLE Study EADV, 2022

Innovent Reports Second Interim P-III (ORIENT-31) Study Results of Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab) for EGFR-Mutated Non-Squamous NSCLC

Published: Sept 8, 2022 | Tags: Innovent, Tyvyt, sintilimab, Byvasda, biosimilar, bevacizumab, EGFR-Mutated Non-Squamous NSCLC, Clinical Trial, P-III ORIENT-31 Study

Arcutis Entered into an Agreement to Acquire Ducentis BioTherapeutics for ~430M

Published: Sept 8, 2022 | Tags: Arcutis, Ducentis BioTherapeutics, DS-234, Atopic Dermatitis, Acquire, ~430M, M&A

Pfizer’s PF-06760805 Receives the US FDA’s Breakthrough Therapy Designation for the Prevention of Infection in Infants

Published: Sept 7, 2022 | Tags: Pfizer, PF-06760805, Infection, Regulatory, US, FDA, Breakthrough Therapy Designation

Zealand Entered into a License and Development Agreement with Novo Nordisk for Zegalogue (dasiglucagon) to Treat Diabetes

Published: Sept 7, 2022 | Tags: Zealand, Novo Nordisk, Zegalogue, dasiglucagon, Diabetes, Pharma

Ionis and AstraZeneca Present P-III (NEURO-TTRansform) Study Results of Eplontersen for Hereditary Transthyretin-Mediated Amyloid Polyneuropathy at ISA 2022

Published: Sept 7, 2022 | Tags: Ionis, AstraZeneca, Eplontersen, Hereditary Transthyretin-Mediated Amyloid Polyneuropathy, Clinical Trial, P-III NEURO-TTRansform Study, ISA, 2022

AstraZeneca Presents (XALOC) Programme Results of Fasenra (benralizumab) for the Treatment of Severe Eosinophilic Asthma at ERS 2022

Published: Sept 7, 2022 | Tags: AstraZeneca, Fasenra, benralizumab, Severe Eosinophilic Asthma, Clinical Trial, XALOC Programme

Kite’s Tecartus Receives EC’s Approval for the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia

Published: Sept 7, 2022 | Tags: Kite, Tecartus, Acute Lymphoblastic Leukemia, Regulatory, EC, Approval 

Synaffix Out-Licenses ADC Technology Platform to Emergence for Cancer

Published: Sept 7, 2022 | Tags: Synaffix, Emergence, ETx-22, Cancer, Out-Licenses, ADC Technology Platform, Biotech

Oculis Reports Results of OCS-01 in P-II (DX-211) Study for the Treatment of Diabetic Macular Edema

Published: Sept 6, 2022 | Tags: Oculis, OCS-01, Diabetic Macular Edema, Clinical Trial, P-II, DX-211, P-III, DIAMOND

Abivax Publishes Results of Obefazimod (ABX464) in P-IIb Trial for the Treatment of Ulcerative Colitis in the Lancet Gastroenterology & Hepatology

Published: Sept 6, 2022 | Tags: Abivax, IQVIA, Obefazimod, ABX464, Ulcerative Colitis, Clinical Trial, US, Europe, Japan, P-IIb, P-III, Lancet Gastroenterology & Hepatology

Bertis Publishes Result on Proteomic Based Research of New Biomarker for the Diagnosis of Ovarian Cancer

Published: Sept 6, 2022 | Tags: Bertis, Ovarian Cancer, Proteomic Based Research, New Biomarker

CVS Health to Acquire Signify Health for ~$8B

Published: Sept 6, 2022 | Tags: CVS Health, Signify Health, Mountain Capital , M&A ~$8B

Avactas’ AVA6000 Receives Orphan Drug Designation from the US FDA to Treat Soft Tissue Sarcoma

Published: Sept 6, 2022 | Tags: Avactas, AVA6000, Soft Tissue Sarcoma, Orphan Drug Designation, P-III, US, FDA

Boehringer Ingelheim Reports Results of OFEV in P-III (InPedILD) Study for the Treatment of Fibrosing Interstitial Lung Disease

Published: Sept 6, 2022 | Tags: Boehringer Ingelheim, OFEV, Fibrosing Interstitial Lung Disease, Clinical Trial, P-III, InPedILD, US, FDA, EMA

AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Approval as the First Immunotherapy Regimen for Advanced Biliary Tract Cancer

Published: Sept 5, 2022 | Tags: AstraZeneca, Imfinzi, durvalumab, Advanced Biliary Tract Cancer, Regulatory, US, FDA, Approval

Sanofi Presents P-III (LIBERTY ASTHMA EXCURSION) trial Results of Dupixent (dupilumab) for Moderate to Severe Asthma at ERS 2022

Published: Sept 5, 2022 | Tags: Sanofi, Dupixent, dupilumab, Asthma, P-III LIBERTY ASTHMA EXCURSION trial, ERS, 2022

Astellas Reports P-III (MOONLIGHT 3) Trial Results of Fezolinetant for the Treatment of Vasomotor Symptoms Associated with Menopause

Published: Sept 5, 2022 | Tags: Astellas, Fezolinetant, Vasomotor Symptoms, Menopause, Clinical Trial, P-III MOONLIGHT 3 Trial

BMS’ Azacitidine Receives NICE Recommendation for the Treatment of Acute Myeloid Leukaemia

Published: Sept 5, 2022 | Tags: BMS, Azacitidine, Acute Myeloid Leukaemia, Regulatory, NICE, Recommendation

Gilead Reports P-III (TROPiCS-02) Study Results of Trodelvy (sacituzumab govitecan-hziy) for HR+/HER2- Metastatic Breast Cancer

Published: Sept 5, 2022 | Tags: Gilead, Trodelvy, sacituzumab govitecan-hziy, HR+/HER2- Metastatic Breast Cancer, Clinical Trial, P-III TROPiCS-02 Study

Innovent Reports First Patient Dosing in P-II Clinical Trial of Mazdutide for the Treatment of Obesity in Chinese Adults

Published: Sept 5, 2022 | Tags: Innovent, Mazdutide, Obesity, Clinical Trial, P-II Clinical Trial, Chinese Adults

Related Post: PharmaShots Weekly Snapshots (August 29 – September 02, 2022)


Neha

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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