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)