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NEWS

Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)

Shots: Following the US FDA approval, the EC has approved Avtozma (biosimilar, RoActemra) to treat mod. to sev. rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA) Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs RoActemra (tocilizumab) in mod. to sev.…
February 24, 2025

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Celltrion
NEWS

Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)

Shots: Following the US FDA approval, the EC has approved Avtozma (biosimilar, RoActemra) to treat mod. to sev. rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA) Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs RoActemra (tocilizumab) in mod. to sev.…
February 24, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (February 17th, 2025 – February 21th, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, COVID 19 & Biosimilars. Check out our full report below:      AstraZeneca Presents Post-Hoc Data from P-III (NIAGARA) Trial of Imfinzi in Muscle-Invasive Bladder Cancer Patients regardless of Complete Pathology Response at ASCO GU 2025  Read More: AstraZeneca  Exelixis Presents 5-year…
February 21, 2025

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Gilead
NEWS

Gilead Receives EC’s Conditional Marketing for Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Shots: Following the MHRA approval (Jan 2025), the EC has granted conditional MAA to Seladelpar +/- ursodeoxycholic acid (UDCA) to treat PBC in those with inadequate response or intolerants to UDCA, respectively; ongoing regulatory review in Canada and Australia MAA was based on a worldwide P-III (RESPONSE) study assessing seladelpar (10mg, QD, oral) vs…
February 21, 2025

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Merck
NEWS

Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

Shots: The EC has approved Welireg for VHL-related localized RCC, CNS hemangioblastomas, or pNET unsuitable for localized procedures and advanced ccRCC post-PD-1/PD-L1 inhibitors or VEGF therapies progression across EU member states, as well as Iceland, Liechtenstein & Norway Approval for VHL-related tumors was based on P-II (LITESPARK-004) study (n=61), showing ORR of 49% (all…
February 19, 2025

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Merus
NEWS

Merus Receives the US FDA’s Breakthrough Therapy Designation for Petosemtamab to Treat 1L PD-L1+ Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Shots: The US FDA has granted BTD to petosemtamab + Keytruda as 1L treatment of r/m HNSCC harboring PD-L1 (CPS ≥ 1) in adults BTD was backed by interim data from ongoing P-I/II trial evaluating petosemtamab + Keytruda in mentioned pts that showed 67% response rate in 24 evaluable pts with further data presented…
February 19, 2025

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Innate Pharma
NEWS

The US FDA Grants Breakthrough Therapy Designation to Innate Pharma’s Lacutamab for R/R Sézary Syndrome

Shots: The US FDA has granted BTD to lacutamab for the treatment of adults with r/r sézary syndrome after receiving ≥2L of therapy incl. mogamulizumab Designation was based on P-I as well as P-II (TELLOMAK) trial data, showing efficacy & favorable safety in pts who were heavily pre-treated with mogamulizumab Additionally, Lacutamab (anti-KIR3DL2…
February 18, 2025

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