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Formycon Launches Epruvy (Biosimilar, Lucentis) in the Germany
Shots:  Sandoz commercializes Epruvy (Biosimilar, Lucentis) across Germany in PFS and vial forms, following an agreement with Formycon and Bioeq   Epruvy (ranibizumab)was approved by the EMA in Sep'24 to treat severe visual impairments like nAMD and other retinopathies and is marketed by Sandoz in Germany under a Bioeq license   Epruvy is available in vials and pre-filled syringes, offering a convenient treatment option in Germany  Ref: Formycon | Image: Formycon  | Press Release Related…
November 20, 2025
Alvotech and Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the EC Approval to Treat Several Chronic Inflammatory Diseases
Shots: The EC has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis (with methotrexate), PsA (± methotrexate), ankylosing spondylitis & ulcerative colitis in adult pts & juvenile idiopathic arthritis (with methotrexate) across 30 EEA states Approval was based on extensive data, incl.…
November 20, 2025
Merck new
Merck Reveals Topline P-III (MK-8591A-053) Trial Data on Doravirine/Islatravir to Treat HIV-1 Infection
Shots: The P-III (MK-8591A-053) trial data assessed 100mg doravirine/0.25mg islatravir (DOR/ISL; QD, PO) vs 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide (BIC/FTC/TAF; QD, PO) ) in treatment-naïve adults with HIV-1 infection (n=537) Trial met its primary efficacy hypothesis, with DOR/ISL showing non-inferiority to BIC/FTC/TAF in achieving HIV-1 RNA <50 copies/mL at Wk. 48, & also achieved its…
November 20, 2025
Accord BioPharma Receive the US FDA’s Approval for Osvyrti and Jubereq (Biosimilar, Prolia and Xgeva)   
Shots:  The US FDA has approved Osvyrti and Jubereq biosimilars to Prolia and Xgeva. Accord is anticipated to commercialize OSVYRTI and JUBEREQ in 2026   The approvals were supported by a P-I study showing JUBEREQ and Xgeva had comparable PK, and a P-III study in postmenopausal women with osteoporosis demonstrating that OSVYRTI and Prolia are highly similar with no clinically meaningful differences in PK, PD, safety, or efficacy  Intas has an exclusive…
November 20, 2025
Merck new
Merck’s Keytruda SC Receives the EC Approval for Subcutaneous Use Across 33 Solid Tumor Indications for Keytruda
Shots: The EC has approved Keytruda SC (pembrolizumab & berahyaluronidase alfa-pmph) for SC dosing in adults across all 33 Keytruda indications in all 30 EEA states, with availability subject to multiple factors, incl. national reimbursement processes Approval was based on P-III (3475A-D77) trial assessing Keytruda SC (790mg/9600 units, Q6W; n=251) vs IV Keytruda (400mg, Q6W;…
November 20, 2025
Insmed Reports the EC’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)
Shots: The EC has approved Brinsupri (25mg) for treating NCFB pts (≥12yrs.), with ≥2 exacerbations in the prior 12mos. under EMA'saccelerated assessment pathway; Application is under PMDA & MHRA review, & Insmed is planning to work with EU authorities to enable patient access starting in early 2026 Approval was based on extensive clinical data, incl. P-III (ASPEN)…
November 19, 2025
Merck new
Merck Reports P-II (CADENCE) Trial Data on Winrevair for Combined Post and Precapillary Pulmonary Hypertension (CpcPH) due to HFpEF
Shots: Merck has reported topline P-II (CADENCE) trial data assessing Winrevair (sotatercept-csrk; 0.3 or 0.7mg/kg) vs PBO in 164 pts with CpcPH due to heart failure with preserved ejection fraction (HFpEF) Trial met its 1EP, showing a reduction in pulmonary vascular resistance at 24wks. along with a favorable safety profile. Data will be presented at a…
November 19, 2025
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