This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:
Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC
Read More: Daiichi Sankyo
Genentech Reports P-III (ALLEGORY) Trial Findings on Gazyva (Obinutuzumab) for Systemic Lupus Erythematosus (SLE)
Read More: Genentech
UCB Reports Results from BE HEARD Trials on Bimzelx (Bimekizumab-bkzx) to Treat Hidradenitis Suppurativa
Read More: UCB
HUTCHMED Completes Enrollment in Global P-III (SAFFRON) Study of Orpathys + Tagrisso in Lung Cancer Patients
Read More: HUTCHMED
Novo Nordisk Reveals P-III (REDEFINE 1) Trial Data on CagriSema for Cardiovascular Risk Factors
Read More: Novo Nordisk
Belite Bio Reports the MHRA’s CMA Application Acceptance for Tinlarebant to Treat Stargardt Disease
Read More: Belite Bio
Calluna Pharma’s CAL101 Receives the US FDA’s Orphan Drug Designation to Treat Idiopathic Pulmonary Fibrosis (IPF)
Read More: Calluna Pharma
UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)
Read More: UCB
Meitheal Pharmaceuticals Receives the US FDA Approval for Contepo (Fosfomycin) Injection to Treat cUTI in Adults
Read More: Meitheal Pharmaceuticals
Averoa Receives the MHRA’s Approval for Xoanacyl to Treat Chronic Kidney Disease (CKD)
Read More: Averoa
Neurona Therapeutics’ NRTX-1001 Secures the EMA’s Priority Medicines (PRIME) Designation for Drug-Resistant Focal Epilepsy
Read More: Neurona Therapeutics
argenx Receives Health Canada’s Approval for Vyvgart SC to Treat Chronic Inflammatory Demyelinating Polyneuropathy
Read More: argenx
Johnson & Johnson’s Darzalex Faspro Secures the US FDA’s Approval for High-Risk Smouldering Multiple Myeloma (SMM)
Read More: J&J
Johnson & Johnson Reports the US FDA’s Approval of Caplyta (Lumateperone) for Major Depressive Disorder
Read More: J&J
TransThera Sciences Inks Up to $881.5M Deal with Neurocrine Biosciences to Advance NLRP3 Inhibitors
Read More: TransThera Sciences & Neurocrine Biosciences
Manifold Bio Partners with Roche to Develop BBB shuttles for Neurological and Neurodegenerative Diseases
Read More: Manifold Bio & Roche
Kaigene Inks ~$744M Licensing Deal with Celltrion for KG006 and KG002 to Treat Autoimmune Diseases
Read More: Kaigene & Celltrion
Boehringer Ingelheim and CDR-Life Expand their Partnership with a Global Licensing Deal for CDR111
Read More: BI & CDR-Life
Merck Signs an R&D Funding Deal with Blackstone Life Sciences for Sacituzumab Tirumotecan (sac-TMT)
Read More: Merck & Blackstone Life Sciences
Ailux Collaborates with Eli Lilly to Accelerate Bispecific Antibody Development
Read More: Ailux & Eli Lilly
AmacaThera Inks a ~$230M Exclusive Global Licensing Deal with Pacira BioSciences to Advance AMT-143
Read More: AmacaThera & Pacira BioSciences
BD Secures the US FDA’s 510(k) Clearance and European CE-IVDR Certification for Enteric Bacterial Panels (EBP) on the BD COR System
Read More: BD
Aqua Medical Receives the US FDA IDE Approval to Initiate Trial for Ablation Procedure to Treat Uncontrolled Type 2 Diabetes
Read More: Aqua Medical
UroViu Receives European CE Certification for its Cystoscope and Hysteroscope Portfolio
Read More: UroViu
Nitinotes Reports the European CE Mark Approval of EndoZip for Endoscopic Sleeve Gastroplasty
Read More: Nitinotes
QIAGEN to Acquire Parse Biosciences for ~$280M
Read More: QIAGEN & Parse Biosciences
Alvotech Provides Update on BLA of AVT05 (Biosimilar, Simponi)
Read More: Alvotech
Sandoz Acquires Just-Evotec Biologics EU SAS in Toulouse to Strengthen its In-House Biosimilar Capabilities
Read More: Sandoz & Just-Evotec Biologics
Alvotech & Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the MHRA’s Approval to Treat Several Chronic Inflammatory Diseases
Read More: Alvotech & Advanz Pharma
Dechra Introduces Solovecin to Treat Skin Infections in Dogs and Cats
Read More: Dechra
Related Post: PharmaShots Weekly Snapshots (Oct 27, 2025 – Oct 31, 2025)
