This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health, and Biosimilars. Check out our full report below:
AstraZeneca and Daiichi Sankyo Report P-III (TROPION-Breast02) Trial Results of Datroway for Triple-Negative Breast Cancer
Read More: AstraZeneca and Daiichi Sankyo
AstraZeneca Reports P-III (Bax24) Trial Data on Baxdrostat for Treatment-Resistant Hypertension
Read More: AstraZeneca
AbbVie Reports Topline P-II (ELATE) Trial Data on Botox (OnabotulinumtoxinA) for Upper Limb Essential Tremor
Read More: AbbVie
Sanofi Reports P-II (ALPHAMEDIX-02) Trial Data of AlphaMedix for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)
Read More: Sanofi
Bavarian Nordic Announces Topline P-II Trial Data of MVA-BN Mpox/Smallpox Vaccine in Younger Population
Read More: Bavarian Nordic
Eli Lilly Reports P-III (LUCENT-3) OLE Trial Data of Omvoh to Treat Ulcerative Colitis
Read More: Eli Lilly
Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya (Guselkumab) for Ulcerative Colitis (UC)
Read More: J&J
Ono Pharmaceutical Reports the P-II (ONO-4578-08) Trial Findings of ONO-4578 in Gastric or Gastroesophageal Junction Cancer
Read More: Ono Pharmaceutical
Santhera Pharmaceuticals Reports Health Canada’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy
Read More: Santhera Pharmaceuticals
Daiichi Sankyo Reports the MHLW’s sNDA Submission of Enhertu + Perjeta to Treat HER2+ Breast Cancer
Read More: Daiichi Sankyo
Arcutis Biotherapeutics Receives the US FDA’s Approval for Zoryve Topical Cream to Treat Atopic Dermatitis
Read More: Arcutis Biotherapeutics
Regeneron Reports the US FDA’s Approval of Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)
Read More: Regeneron
Ascendis Pharma Reports the EMA’s MAA Submission for TransCon CNP to Treat Achondroplasia in Children
Read More: Ascendis Pharma
Boehringer Ingelheim Reports the US FDA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis
Read More: BI
Adcendo’s ADCE-D01 Receives the US FDA’s Fast Track Designation to Treat Soft Tissue Sarcoma
Read More: Adcendo
Chiesi Group Enters a ~$2.1B Deal with Arbor Biotechnologies to Develop Novel Rare Disease Gene Editing Programs
Read More: Chiesi Group & Arbor Biotechnologies
Algen Biotechnologies Collaborates with AstraZeneca to Advance Drug Discovery in Immunology
Read More: Algen Biotechnologies and AstraZeneca
Zenas BioPharma Enters ~$2B Deal with InnoCare Pharma for Three Autoimmune Product Candidates
Read More: Zenas BioPharma & InnoCare Pharma
AviadoBio Enters Exclusive Option & License Agreement with UgeneX Therapeutics to Advance UGX-202
Read More: AviadoBio & UgeneX Therapeutics
IceCure Medical’s ProSense Cryoablation System Receives the US FDA Marketing Authorization for Breast Cancer
Read More: IceCure Medical
Vektor Medical Secures the European CE Mark Approval for AI-Powered vMap System to Advance Arrhythmia Care
Read More: Vektor Medical
Roche and KlinRisk Secure CE Mark for Kidney Klinrisk Algorithm and Unveil CKD Algorithm Panel
Read More: Roche and KlinRisk
Bunkerhill Health Receives the US FDA’s 510(k) Clearance for Bunkerhill MAC to Detect and Quantify Mitral Annular Calcification
Read More: Bunkerhill Health
Novo Nordisk to Acquire Akero Therapeutics for ~$5.2B, Expanding its MASH Portfolio
Read More: Novo Nordisk and Akero Therapeutics
Alvotech and Advanz Pharma Report the EMA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)
Read More: Alvotech and Advanz Pharma
Celltrion Introduces Avtozma IV (Biosimilar, Actemra) in the US
Read More: Celltrion
Hikma and Celltrion Partner to Commercialize Biosimilars Across the MENA Region
Read More: Hikma & Celltrion
Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives the US FDA’s Approval to Treat Multiple Retinal Diseases
Read More: Celltrion
Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across Canada
Read More: Bio-Thera & Intas Pharmaceuticals
Phibro Animal Health Collaborates with Lighthouse Pharmaceuticals for Novel Canine Periodontal Therapy
Read More: Phibro Animal Health & Lighthouse Pharmaceuticals
Related Post: PharmaShots Weekly Snapshots (Sep 29, 2025 – Oct 03, 2025)
