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

Johnson & Johnson Reports P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis 

Read More: J&J 

Intellia Therapeutics Reports the First Patient Dosing in P-III (MAGNITUDE-2) Trial of Nexiguran Ziclumeran for ATTRv-PN 

Read More: Intellia Therapeutics 

Rhythm Pharmaceuticals Reports Topline Data from P-III (TRANSCEND) Trial of Setmelanotide for Acquired Hypothalamic Obesity 

Read More: Rhythm Pharmaceuticals 

Remegen Reports P-III Trial Data of Telitacicept for Generalized Myasthenia Gravis (gMG) 

Read More: Remegen 

Johnson & Johnson Reports P-III (Vivacity-MG3) Trial Data of Nipocalimab for Generalized Myasthenia Gravis 

Read More: J&J 

Oculis Completes Patient Enrollment in P-III (DIAMOND-1 & DIAMOND-2) Trials of OCS-01 for Diabetic Macular Edema 

Read More: Oculis 

Johnson & Johnson Reveals P-III (ICONIC-LEAD) Trial Data of Icotrokinra for Plaque Psoriasis 

Read More: J&J 

Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM) 

Read More: J&J 

Teva Pharmaceuticals Reports the US FDA’s sBLA Acceptance of Ajovy (Fremanezumab) for Pediatric Episodic Migraine Prevention 

Read More: Teva Pharmaceuticals 

The EC Approves AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults 

Read More: AbbVie 

Johnson & Johnson Receives the EC’s Approval for SC Rybrevant to Treat Advanced EGFR-Mutated NSCLC 

Read More: J&J 

BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC) 

Read More: BMS 

AstraZeneca and Daiichi Sankyo Receive the EC’s Approval for Datroway to Treat HR+/HER2- Breast Cancer 

Read More: AstraZeneca and Daiichi Sankyo 

Bayer's Vitrakvi Receives the US FDA’s Full Approval for NTRK Fusion-Positive Solid Tumors 

Read More: Bayer 

argenx Reports the US FDA’s Approval of Vyvgart Hytrulo Prefilled Syringe for gMG and CIDP 

Read More: argenx 

Health Canada Approves AstraZeneca’s Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC) 

Read More: AstraZeneca 

ABL Bio Licenses Grabody-B Brain Delivery Platform to GSK for ~$2.76B (£2.15B) 

Read more: ABL Bio and GSK 

Luye Pharma Launches Erzofri in the US for Schizophrenia and Schizoaffective Disorder 

Read More: Luye Pharma 

Ethris Partners with Lonza to Develop Intranasal Spray-Dried mRNA Vaccines Against Respiratory Diseases 

Read More: Ethris and Lonza 

KalVista Pharmaceuticals Partners with Kaken Pharmaceutical to Commercialize Sebetralstat in Japan 

Read More: KalVista Pharmaceuticals and Kaken Pharmaceutical 

AliveDx Seeks the US FDA’s 510(k) Clearance for MosaiQ AiPlex Connective Tissue Diseases (CTDplus) Multiplex Microarray 

Read More: AliveDx 

J&J MedTech Reports First Patient Enrollment in FORWARD CAD trial of Shockwave Javelin Coronary IVL Catheter 

Read More: J&J MedTech 

Womed Collaborates with Kebomed Europe & Saesco Medical to Launch Womed Leaf in Europe 

Read More: Womed, Kebomed Europe & Saesco Medical 

Merit Medical Reports the US Launch of Ventrax Delivery System 

Read More: Merit Medical 

Elixir Medical Reports European MDR CE Mark Approval & Launch of LithiX Hertz Contact IVL System 

Read More: Elixir Medical 

Teva and Samsung Bioepis Launch Epysqli (Biosimilar, Soliris) in the US 

Read More: Teva and Samsung Bioepis 

The US FDA Approves Biocon Biologics’ Jobevne (Biosimilar, Avastin) 

Read More: Biocon Biologics 

OS Therapies Reports Clinical Data of OST-HER2 for the Treatment of Unresected Osteosarcoma in Dogs 

Read More: OS Therapies 

Scientist.com Launches Clinical Labs Navigator to Improve Clinical Trial Operations 

Read More: Scientist.com 

Makana Therapeutics Partners with Tonix Pharmaceuticals for TNX-1500 

Read More: Makana Therapeutics and Tonix Pharmaceuticals  

Related Post: PharmaShots Weekly Snapshots (March 31, 2025 – April 04, 2025)