This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, Biosimilars & Animal Health. Check out our full report below:

AstraZeneca to Highlight Tagrisso’s Clinical Data for NSCLC at ELCC 2025 

Read More: AstraZeneca 

Accent Therapeutics to Highlight Preclinical Data of ATX-559 and ATX-295 at AACR 2025 

Read More: Accent Therapeutics 

Axsome Therapeutics Reports P-III (FOCUS) Trial Data of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) 

Read More: Axsome Therapeutics 

Johnson & Johnson Reports P-III (MARIPOSA) Trial Data of Rybrevant + Lazcluze for EGFRm NSCLC 

Read More: J&J 

Merck Presents P-III (3475A-D77) Trial Data of SC Keytruda for NSCLC at ELCC 2025 

Read More: Merck 

China’s NMPA Approves Junshi Biosciences’ Toripalimab + Bevacizumab for Advanced Hepatocellular Carcinoma 

Read More: Junshi Biosciences 

GSK Reports the EMA’s Acceptance of Nucala (Mepolizumab) as an Add-on Treatment for COPD 

Read More: GSK 

Sanofi Reports the US FDA’s Acceptance & Priority Review of Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis 

Read More: Sanofi 

SineuGene Therapeutics Reports the US FDA’s IND Clearance of SNUG01 for Amyotrophic Lateral Sclerosis 

Read More: SineuGene Therapeutics 

GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tract Infections (uUTIs) 

Read More: GSK 

Exelixis Reports the US FDA’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs) 

Read More: Exelixis 

Merck Secures the EC’s Approval for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for Invasive Pneumococcal Disease (IPD) 

Read More: Merck 

BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM) 

Read More: BridgeBio 

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD) 

Read More: Sanofi and Regeneron 

AstraZeneca Collaborates with Syneron Bio to Develop Macrocyclic Peptides for Chronic Diseases 

Read More: AstraZeneca & Syneron 

Harbour BioMed & AstraZeneca Partner to Develop Multi-Specific Antibodies across Various Therapeutic Areas 

Read More: Harbour BioMed & AstraZeneca 

The United Laboratories (TUL) and Novo Nordisk Enter exclusive license agreement for UBT251 

Read More: TUL and Novo Nordisk 

Alumis and Kaken Pharmaceutical Enter Collaboration & Licencing Deal for ESK-001’s Development & Commercialization in Japan 

Read More: Alumis and Kaken Pharmaceutical 

Merck Partners with Jiangsu Hengrui Pharmaceuticals for HRS-5346, Expanding its Cardio-Metabolic Portfolio 

Read More: Merck and Jiangsu Hengrui Pharmaceuticals 

Bayer Enters Global License Agreement with Suzhou Puhe BioPharma for its PRMT5 Inhibitor 

Read More: Bayer 

Ionis Partners with Sobi for Olezarsen to Treat Familial Chylomicronemia Syndrome (FCS) & Severely Elevated Triglycerides 

Read More: Ionis and Sobi 

Newronika's AlphaDBS Receives European CE Mark for Adaptive Deep Brain Stimulation in Parkinson's Disease 

Read More: Newronika 

Avatar Medical & FX Shoulder Solutions Reports the US FDA’s 510(k) Clearance of brAIn Shoulder Positioning System (SPS) for Arthroscopic Surgeries 

Read More: Avatar Medical & FX Shoulder Solutions 

Huntleigh Healthcare Reports the US FDA’s 510(k) Clearance of Dawes-Redman CTG Analysis to Improve Non-Stress Test Interpretation in Fetuses 

Read More: Huntleigh Healthcare 

Abbott Secures European CE Mark for Volt PFA System to Treat Atrial Fibrillation 

Read More: Abbott 

Zoetis Reports Clinical Data of Librela for Canine Osteoarthritis Pain 

Read More: Zoetis 

Alvotech, Kashiv Biosciences and Advanz Pharma Report the MHRA’s MAA Acceptance of AVT23 (Biosimilar, Xolair) 

Read More: Alvotech, Kashiv Biosciences and Advanz Pharma  

The US FDA Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) 

Read More: Fresenius 

Related Post: Pharmashots Weekly Snapshots (March 17, 2025 - March 25, 2025)