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Amgen
NEWS

The CHMP Recommends Amgen’s Imdylltra to Treat 1L ES-SCLC   

Shots:  The CHMP has recommended Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with Pt-based CT  Opinion was based on the P-III study in 509 ES-SCLC pts post Pt therapy, where Imdylltra showed improved mOS (13.6 vs 8.3 mos.; ~40% lower death risk) and higher mPFS (4.2 vs 3.2 mos.) vs SoC  Imdylltra is…
March 26, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in February 2026    

Shots:  The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK  The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric…
March 17, 2026

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NEWS

ImmunityBio’s Anktiva + BCG Receives EC Conditional Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Shots: The EC has granted conditional approval to Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors in all 30 EEA states, based on P-II/III (QUILT-3.032) study (n=100) Trial showed a 71% CR rate, with a median duration of CR of 26.6mos., plus DoR range was as long as…
February 19, 2026

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NEWS

Rezon Bio’s Warsaw-Duchnice facility Receives the US FDA Approval for Commercial Manufacturing 

Shots:  The US FDA grants approval for commercial manufacturing of a biosimilar at Rezon Bio’s Warsaw-Duchnice facility  The FDA approval of the Warsaw-Duchnice facility follows a comprehensive review process and indicates that the site meets regulatory standards for quality systems, technical capabilities, and operational readiness to supply the US market  This approval follows earlier EMA GMP certification and authorization for commercial…
February 18, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in January 2026    

Shots:  The European Commission approved multiple therapies across vaccines, rare diseases, endocrinology, and immunology, including products from BioNet, Sanofi, Fondazione Telethon, IntraBio, and Ionis / Otsuka.  The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from UCB and Gedeon Richter, with additional recommendations supporting Sanofi’s Rezurock.  Decisions were backed by strong Phase II/III data…
February 17, 2026

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Bio-Thera Solutions Expands its Partnership with STADA for BAT1806 (Biosimilar, RoActemra)
NEWS

STADA & Bio-Thera Receive the EC approval for Gotenfia (Biosimilar, Simponi)

Shots: The EC has approved STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), in all 30 EEA states, with launch preparations ongoing Approval was based on extensive analytical, non-clinical & clinical data demonstrating biosimilarity of BAT2506 to Simponi In May 2024 deal, STADA obtained exclusive commercial rights to Gotenfia…
February 16, 2026

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Incyte
NEWS

The CHMP Recommends Incyte’s Zynyz to Treat Squamous Cell Carcinoma of the Anal Canal (SCAC)

Shots: The CHMP has recommended Zynyz (retifanlimab) + Pt-based CT as 1L treatment of adults with metastatic or with inoperable locally recurrent SCAC Opinion was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + carboplatin & paclitaxelvs PBO & CT in treatment-naïve SCAC pts P-III trial showed a 37% PFS improvement (mPFS: 9.3 vs 7.4mos.); data…
February 3, 2026

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