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

Algiax Pharmaceuticals Reports Topline Data from P-IIa Trial of AP-325 for Neuropathic Pain 

Read More: Algiax Pharmaceuticals 

Pfizer Reveals Data from the P-III (BREAKWATER) trial of Braftovi Regimen in Patients with Metastatic Colorectal Cancer 

Read More: Pfizer 

Cumberland Pharmaceuticals Reveals Topline Data from P-II (FIGHT DMD) Trial of Ifetroban for Duchenne Muscular Dystrophy Heart Disease 

Read More: Cumberland Pharmaceuticals 

Akeso Completes Patient Enrollment in P-III (HARMONi-6/AK112-306) Trial of Ivonescimab for Squamous NSCLC 

Read More: Akeso 

Merck Initiates P-III (waveLINE-010) Trial of Zilovertamab Vedotin to Treat Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) 

Read More: Merck 

Novo Nordisk Reveals Interim Data from P-III (FRONTIER3) Trial of Mim8 for Haemophilia A with or without Inhibitors 

Read more: Novo Nordisk 

AstraZeneca and Daiichi Sankyo Receive CHMP’s Positive Opinion for Datroway to Treat HR+/HER2- Breast Cancer 

Read More: AstraZeneca and Daiichi Sankyo 

Merck Receives CHMP’s Positive Opinion for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) for Invasive Pneumococcal Disease (IPD) 

Read More: Merck 

Novo Nordisk Reports the US FDA’s Approval for Ozempic to Reduce Risk of Kidney Disease Progression & Cardiovascular Death in Type 2 Diabetes & Chronic Kidney Disease (CKD) Adults 

Read More: Novo Nordisk 

Bavarian Nordic Receives CHMP’s Positive Opinion for Vimkunya to Prevent Chikungunya 

Read More: Bavarian Nordic 

Johnson & Johnson Receives the CHMP Positive Opinion on Label Extension to SC Rybrevant for the Treatment of Advanced EGFR-Mutated NSCLC 

Read More: Johnson & Johnson 

Bayer Submits MAA of Finerenone to the EMA for Heart Failure (HF) 

Read More: Bayer 

Roche Reports the US FDA’s Approval of Susvimo to Treat Diabetic Macular Edema (DME) 

Read More: Roche 

Japan’s MHLW Receives NDA for Conditional Approval of Astellas’ Avacincaptad Pegol to Treat Geographic Atrophy 

Read More: Astellas 

The US FDA grants RMAT Designation to Gradalis’ Vigil for Advanced Ovarian Cancer 

Read More: Gradalis 

Accord Healthcare (Intas) Receives EC Approval for Hetronifly (Serplulimab) as 1L Treatment of ES-SCLC 

Read More: Accord Healthcare (Intas) 

AstraZeneca Reports CHMP Positive Opinion for Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC) 

Read More: AstraZeneca 

Adicet Bio’s ADI-001 Secures the US FDA’s Fast-Track Designation for Treating Refractory SLE with Extrarenal Involvement 

Read More: Adicet Bio 

The US FDA Approves Supernus’ Onapgo (Apomorphine Hydrochloride) for Parkinson’s Disease 

Read More: Supernus 

Jupiter Neurosciences Collaborates with Zina Biopharmaceuticals to Advance Jotrol in P-II Trial for Parkinson’s Disease 

Read More: Jupiter Neurosciences and Zina Biopharmaceuticals 

Vanda Pharmaceuticals Enters into an Exclusive Global License Agreement with AnaptysBio to Develop and Commercialize Imsidolimab 

Read More: Vanda Pharmaceuticals and AnaptysBio 

Aldevron Collaborates with TriLink BioTechnologies for CleanCap mRNA Capping Technology 

Read More: Aldevron and TriLink BioTechnologies 

Imagene Partners with Tempus AI to Develop AI-Powered Diagnostics for NSCLC 

Read More: Imagene and Tempus AI 

Relmada Therapeutics Acquires Sepranolone from Asarina Pharma for ~$3.12M 

Read More: Relmada Therapeutics and Asarina Pharma 

Datar Cancer Genetics Launches Exacta AI to Offer Personalized Treatment Options for Cancer Patients 

Read More: Datar Cancer Genetics 

Gyder Surgical Reports the US FDA’s 510(k) Clearance for Gyder Hip System 

Read More: Gyder Surgical 

Senseonics Seeks the CE Mark Approval for Eversense 365 System 

Read More: Senseonics 

Alumis Signs a Definitive Merger Agreement with ACELYRIN to Develop Novel Therapies for Immune-mediated Diseases 

Read More: Alumis and ACELYRIN 

Anivive Lifesciences Receives $20M Funding from Leonid Capital Partners to Develop Novel Programs for Pets 

Read More: Anivive Lifesciences and Leonid Capital Partners 

Dawn Health & Novartis Introduce Cora BC to Support Breast Cancer Patients 

Read More: Dawn Health & Novartis 

Related Post: PharmaShots Weekly Snapshots (January 27, 2025 – January 31, 2025)