This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, Biosimilar & Animal Health. Check out our full report below:
Recursion Presents Preliminary P-Ib/II (TUPELO) Trial Data of REC-4881 for Familial Adenomatous Polyposis (FAP) at DDW 2025
Read More: Recursion
Chengdu Origen and Vanotech Report the First Patient Dosing in P-I (VAN-2401) Trial of KH658 for Wet Age-related Macular Degeneration
Read More: Chengdu Origen and Vanotech
Immutep Reports P-IIb (KEYNOTE-C34/ TACTI-003) Trial Data of Eftilagimod Alfa + Keytruda for Head and Neck Squamous Cell Carcinoma (HNSCC)
Read More: Immutep
Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya for Ulcerative Colitis (UC)
Read More: J&J
Daiichi Sankyo and AstraZeneca Report Topline P-III (DESTINY-Breast11) Trial Data of Neoadjuvant Enhertu for HER2+ Early-Stage Breast Cancer
Read More: Daiichi Sankyo and AstraZeneca
Gilead Reports Final P-III (MYR301) Trial Data of Bulevirtide for Patients Living with Chronic Hepatitis Delta Virus
Read More: Gilead
GSK Reports the P-III (GLISTEN) Study Results of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus
Read More: GSK
Cognition Therapeutics Reports Topline P-II (MAGNIFY) Trial Data of Zervimesine for Geographic Atrophy (GA)
Read More: Cognition Therapeutics
Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management
Read More: Novo Nordisk
Vanda Pharmaceuticals Reports the US FDA’s NDA Acceptance of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia
Read More: Vanda Pharmaceuticals
Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA
Read More: Omeros
Johnson & Johnson Reports the EC’s Approval of Subcutaneous & Intravenous Tremfya for Active Crohn’s Disease
Read More: J&J
AstraZeneca’s Calquence (Acalabrutinib) Plus Chemoimmunotherapy Secures the EC’s Approval for 1L Mantle Cell Lymphoma (MCL)
Read More: AstraZeneca
China’s NMPA Grants Full Approval to Everest Medicines’ Nefecon for the Treatment of Primary IgAN in Adults at Risk of Disease Progression
Read More: Everest Medicines
Amgen Reports the MHRA’s Approval of Tepezza to Treat Thyroid Eye Disease
Read More: Amgen
FDA Grants Verastem Oncology’s Avmapki + Fakzynja Accelerated Approval for KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)
Read More: Verastem Oncology
ALK Reports Health Canada’s Approval of Itulatek to Treat Children and Adolescents with Allergic Rhinitis
Read More: ALK
UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers
Read More: UTR Therapeutics
VERAXA Biotech Collaborates with OmniAb to Develop Novel Bispecific Antibody Drug Conjugate for Solid Tumors
Read More: VERAXA Biotech and OmniAb
Eli Lilly Enters a ~$415M Licensing Agreement with Alchemab Therapeutics for ATLX-1282 to Treat Amyotrophic Lateral Sclerosis (ALS)
Read More: Eli Lilly and Alchemab Therapeutics
Elanco Inks a $295M Deal with Blackstone for Xdemvy’s Royalties and Milestones, Accelerating Debt Repayment
Read More: Elanco and Blackstone
ViVerita Therapeutics Collaborates with Boehringer Ingelheim to Accelerate Discovery of Novel Therapeutic Targets in Oncology
Read More: ViVerita Therapeutics and BI
Minghui Pharmaceutical and Qilu Pharmaceutical Enter an Exclusive Licensing and Collaboration Agreement for MHB088C
Read More: Minghui Pharmaceutical and Qilu Pharmaceutical
Endogenex Reports REGENT-1 Australian Clinical Study Data of ReCET System for Type 2 Diabetic Duodenopathy
Read more: Endogenex
Roche Launches Elecsys PRO-C3 Test for Liver Fibrosis Severity Assessment
Read More: Roche
Smith+Nephew Reports Trial Data of Cartiheal Agili-C to Treat Knee Cartilage Defects
Read More: Smith+Nephew
ALPCO Launches its Calprotectin Immunoturbidimetric Assay for Irritable Bowel Disease Diagnosis in the EU
Read More: ALPCO
Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation
Read More: Teva and Alvotech
Merck Animal Health’s Mometamax Single Receives the US FDA’s Approval to Treat Dogs with Otitis Externa
Read More: Merck Animal Health
PBI-Gordon Companies Acquires TriviumVet, Expanding its Animal Healthcare Product Portfolio
Read More: PBI-Gordon Companies and TriviumVet
