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Formycon and licensing partner Klinge Biopharma have reported the EU launch of FYB203, a biosimilar version of Eylea 2mg (aflibercept)
FYB203 is now available in the EU as a PFS under the brand names Ahzantive and Baiama. The launch began on May 15, 2026, in key markets including Germany, France, and Italy, with further expansion across Central and Eastern Europe planned…
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Hansa has granted SERB exclusive development & commercialisation rights to Idefirix (imlifidase) in the EU, UK, Switzerland, Norway, Liechtenstein, Iceland & the MENA region
As per the deal, Hansa will receive €110M upfront & an additional €5M upon acceptance of the full approval filing for Idefirix by the EMA. Hansa will also support SERB in…
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Sanofi has reported the P-II (ElevAATe) study data assessing efdoralprin alfa (Q3W or Q4W) vs SoC plasma-derived augmentation therapy (pdAAT; QW) in 97 pts with AATD-related emphysema
Efdoralprin alfa achieved a mean increase in fAAT trough levels of 24.1μM (Q3W) & 16.8μM (Q4W) vs 7.6μM at Wk. 32, with Q3W meeting the 1EP, while…
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The US FDA has approved Immgolis & Immgolis Intri, the interchangeable biosimilar versions of Simponi & Simponi Aria (golimumab), respectively
Immgolis & Immgolis Intri are both approved for the treatment of adults with mod. to sev. active rheumatoid arthritis in combination with methotrexate, while Immgolis is additionally approved for mod. to sev. active ulcerative…
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Regeneron has entered a strategic research collaboration with Parabilis to discover & develop multiple therapeutics using Parabilis’ Helicon peptide platform, with a focus on Antibody-Helicon Conjugates (AHCs)
Regeneron will lead development, manufacturing, & global commercialization, while Parabilis will receive $125M, incl. $50M upfront & a $75M commitment toward its next equity financing, subject to…
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The EC has approved Bysumlog & Dazparda, the biosimilar versions of Humalog (insulin lispro) & NovoRapid (insulin aspart), respectively, as prefilled pens
Bysumlog is approved for the treatment and initial stabilisation of diabetes mellitus in adults & children, while Dazparda is approved for diabetes treatment in pts (≥1yr.). Both demonstrated equivalent efficacy & comparable…
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The US FDA has approved AstraZeneca's Baxfendy in combination with other antihypertensive medications for the treatment of pts with uncontrolled or treatment-resistant hypertension
Approval was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment-resistant hypertension
Trial met…
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PainTEQ has launched TRAQ SI Joint Fusion, a posterior sacroiliac joint implant designed for bi-cortical fixation through engagement of both the sacral & iliac cortices using a tissue-sparing posterior approach, in the US
TRAQ SI Joint Fusion is delivered through a 1-inch incision & features triangular piercing barbs engineered to stabilize the SI joint…
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FDA approved Genentech's Tecentriq & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) as an adj. therapy for adults with MIBC who have ctDNA MRD after cystectomy, as identified by Natera’s Signatera CDx MRD assay, which received simultaneous FDA approval
Approval was based on the P-III (IMvigor011) trial evaluating Tecentriq vs PBO in adults with MIBC & ctDNA…
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FDA has approved Enhertu + THP for neoadj. treatment of adults with HER2+ Stage II/III breast cancer, & Enhertu monotx. for adj. treatment in adults with residual invasive disease post Herceptin (± Perjeta) & taxane-based therapy, triggering a $155M milestone payment from AZ to Daiichi Sankyo
For neoadj. setting, approval was backed by DESTINY-Breast11…

