Tags : EU Approval

Regulatory

Novartis Receives EU Approval for Gene Therapy Luxturna (voretigene neparvovec)

Shots: The approval is based on P-III trial, involving assesment of Luxturna vs control group patients, with inherited retinal disease (caused due to mutation in both copies of the RPE65 gene and sufficient viable retinal cells) Results: Vision improvement recorded @ 30 days following treatment, @1yr. MLMT (multi-luminance mobility test) (1.6); 65% patients successfully navigate […]Read More

Biosimilars Regulatory

Mundipharma Receives EU Approval for Pelmeg (Pegfilgrastim, Biosimilar)

Shots: Pelmeg (Pegfilgrastim, Biosimilar) is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic CT for malignancy CHMP recommends Pelmeg based on the results from pharmacodynamics, pharmacokinetics, and immunogenicity comparisons with Neulasta Pelmeg is Granulocyte-colony stimulating factor (G-CSF) biosimilar that stimulates bone marrow to produce more […]Read More

Biosimilars Pharma

Pfizer receives EU approval for Trazimera(Trastuzumab), the First Oncology Biosimilar

Shots: Trazimera is a biosimilar of Herceptin indicated for treatment of HER2 overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma The EC approval is based on the data including REFLECTION B327-02 clinical study showing similarity b/w Trazimera and original product in patient Trazimera has been studied in ~500 patients across 20 countries Click […]Read More

Pharma

Novartis Announces the EU Approval of first-in-class Aimovig®️(erenumab) for Migraine

Shots:   Results of 2600 patients trial reported significant i.e. ≥50% reduction in migraine days with comparable safety and tolerability to PBO   Aimovig works by blocking calcitonin gene-related peptide receptor (CGRP-R) which plays vital role in migraine   Can be self-administered every four weeks with the Sure Click®️ auto injector pen, device commonly used for […]Read More