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

Shots: The EC has approved Hetronifly + CT (carboplatin & etoposide) as a 1L treatment for extensive-stage small cell lung cancer (ES-SCLC) pts. Serplulimab, an anti-PD-1 mAb for 1L SCLC therapy, is approved in China and several SEA countries. ESMO rates it 4/5 on the MCBS for ES-SCLC. Its trial results were published in…

ByRidhi RastogiFebruary 6, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in December 2024

Shots: The EMA’s CHMP has granted positive opinions to 5 Biologics and 4 New Chemical Entities in December 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Galderma’s Nemluvio to treat Prurigo Nodularis and Atopic Dermatitis PharmaShots has compiled a list of 9 drugs that have been granted positive…

ByDipanshu DixitJanuary 23, 2025

NEWS

GSK’s Jemperli Plus Chemotherapy Receives the EC’s Approval as a 1L Treatment of Primary Advanced or Recurrent Endometrial Cancer

Shots: The EC has approved Jemperli + CT (carboplatin & paclitaxel) as a 1L treatment of primary advanced or recurrent endometrial cancer in adults eligible for systemic therapy Approval was based on part 1 of P-III (RUBY) study assessing Jemperli + CT followed by Jemperli vs CT + PBO followed by PBO and part…

BySenior EditorJanuary 20, 2025

NEWS

InflaRx’s Gohibic (Vilobelimab) Receives the EC Approval for the Treatment of ARDS

Shots: The EC has approved (under exceptional circumstances) Gohibic to treat SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) adults on SoC (incl. systemic corticosteroids) & IMV (with/without ECMO) Approval was backed by results of the P-III (PANAMO) study assessing Gohibic vs. PBO among invasively mechanically ventilated COVID-19 patients in the ICU, which showed improvement in survival with…

ByDipanshu DixitJanuary 17, 2025

NEWS

Ultragenyx Reports the EC’s Approval of Evkeeza (evinacumab) to Treat 6-Months Old Children with Homozygous Familial Hypercholesterolemia (HoFH)

Shots: The EC has approved Evkeeza (an angiopoietin-like 3 inhibitor), as an adjunct to diet & other lipid-lowering therapies, to treat children (6mos. to 5yrs.) with HoFH Approval was based on model-based analysis that predicted similar or greater LDL-C reductions with Evkeeza (15mg/kg, Q4W) in children (6mos. to 5yrs.) at 24wks. Data from compassionate…

BySenior EditorJanuary 6, 2025

NEWS

Dong-A ST Receives EC Approval for Imuldosa (Biosimilar, Stelara)

Shots: Dong-A ST received EC approval for Imuldosa (DMB-3115), a biosimilar of Janssen's Stelara (Ustekinumab), following CHMP’s positive opinion & FDA's approval Imuldosa, initially developed by Dong-A Socio Holdings & Meiji Seika Pharma, & was transferred to Dong-A ST in 2020 for global development and commercialization. In 2021, it was out-licensed to Intas Pharmaceuticals for…

ByDipanshu DixitDecember 19, 2024

NEWS

Samsung Bioepis and Biogen Report the EC’s Approval of Opuviz (Biosimilar, Eylea)

Shots: The EC has granted approval to Opuviz 40 mg/mL solution, biosimilar version of Eylea (aflibercept) and will be commercialized by Biogen as per an agreement b/w the companies Approval of SB15 was based on comprehensive data, incl. a P-III study showing equivalent efficacy, safety, immunogenicity & PK profile to aflibercept. It achieved the 1EP…

ByDipanshu DixitNovember 18, 2024

NEWS

Sandoz Report the EC’s Approval of Afqlir (Biosimilar, Eylea) to Treat Neovascular Age-related Macular Degeneration (nAMD)

Shots: The EC has approved Afqlir(2mg vial kit & pre-filled syringe for intravitreal injection), biosimilar of Bayer’s Eylea (aflibercept), with the launch anticipated in Q4’25 Afqlir's biosimilar development program included analytical, preclinical & clinical data from the Mylight trial, establishing its equivalence in terms of efficacy & safety to the reference medicine Aflibercept is a…

ByDipanshu DixitNovember 15, 2024

NEWS

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases

Shots: The EC has approved Otulfi (IV/SC), a biosimilar of Stelara (ustekinumab), to treat mod. to sev. active CD, mod. to sev. plaque PsO & active PsA, valid across EU as well as Iceland, Liechtenstein & Norway Approval was based on analytical, pre-clinical, clinical & manufacturing data, depicting similar effectiveness, safety & PK profile of…

ByDipanshu DixitSeptember 27, 2024

NEWS

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases

Shots: The EC has approved Otulfi (IV/SC), a biosimilar of Stelara (ustekinumab), to treat mod. to sev. active CD, mod. to sev. plaque PsO & active PsA, valid across EU as well as Iceland, Liechtenstein & Norway Approval was based on analytical, pre-clinical, clinical & manufacturing data, depicting similar effectiveness, safety & PK profile of…

ByDipanshu DixitSeptember 27, 2024

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

EMA Marketing Authorization of New Drugs in December 2024

GSK’s Jemperli Plus Chemotherapy Receives the EC’s Approval as a 1L Treatment of Primary Advanced or Recurrent Endometrial Cancer

InflaRx’s Gohibic (Vilobelimab) Receives the EC Approval for the Treatment of ARDS

Ultragenyx Reports the EC’s Approval of Evkeeza (evinacumab) to Treat 6-Months Old Children with Homozygous Familial Hypercholesterolemia (HoFH)

Dong-A ST Receives EC Approval for Imuldosa (Biosimilar, Stelara)

Samsung Bioepis and Biogen Report the EC’s Approval of Opuviz (Biosimilar, Eylea)

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases

Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases

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