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Daiichi Sankyo
Daiichi Sankyo Reports the Health Canada’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)
Shots: Health Canada has approved Enhertu monotx. for adult with inoperable HR+, HER2-low/ultralow MBC who have received ≥1 endocrine therapy (ET) & are ineligible for ET as the next line of therapy Approval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT (capecitabine/paclitaxel/nab-paclitaxel) in HR+, HER2-low (n=713) & ultralow (n=152) pts Trial showed improved PFS…
October 31, 2025
Celltrion
The FDA Grants Interchangeability Designation to Celltrion’s Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)
Shots: The US FDA has granted interchangeable designation to Stoboclo & Osenvelt, biosimilar versions of Prolia & Xgeva (denosumab), respectively, for all approved indications of the reference product Designation was based on extensive data, incl. analytical data demonstrating similarity of Stoboclo & Osenvelt with reference product & P-III trial results in postmenopausal women with osteoporosis, which showed comparable…
October 30, 2025
ModeX Therapeutics (OPKO Health) Enters $1B+ Deal with Regeneron to Develop Multispecific Antibodies for Select Therapeutic Indications
Shots: ModeX & Regeneron entered into a license & collaboration agreement to develop multispecific antibodies across cancer and metabolic, combining ModeX’s MSTAR platform with Regeneron’s antibody binders Regeneron will fund & lead all development & commercialization in exchange for $7M upfront, plus future product selection, clinical, regulatory, & commercial milestones over $200M per molecule, with…
October 30, 2025
Merck
Merck Receives EC’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
Shots: The EC has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) across all 30 EEA states Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15…
October 30, 2025
Fresenius Kabi
Fresenius Kabi’s Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) Receives FDA’s Interchangeable Designation
Shots: The US FDA has granted interchangeable designation to Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab), respectively, for the treatment of bone & skeletal disorders Conexxence treats adults at high fracture risk, incl. pts with osteoporosis, pts on long-term glucocorticoid therapy or certain cancer treatments affecting bone density Bomyntra prevents SREs in adults with bone-involved malignancies…
October 30, 2025
Thermo Fisher Scientific to Acquire Clario for ~$9.4B
Shots: Thermo Fisher has entered into a definitive agreement to acquire Clario, enhancing its digital & data capabilities in clinical research As per the deal, Thermo Fisher Scientific will acquire Clario for $8.875B in cash, with an additional $125M due in January 2027 & ~$400M in performance-based earnouts for 2026–2027; closing is expected mid-2026, after…
October 29, 2025
Samsung Bioepis Enters Asset Purchase Deal with Biogen for Byooviz (Biosimilar, Lucentis) and Opuviz (Biosimilar, Eylea) in the EU
Shots: Samsung Bioepis has entered an asset purchase agreement with Biogen to acquire its ophthalmology assets, Byooviz & Opuviz, biosimilar versions of Lucentis (ranibizumab) & Eylea (aflibercept), in the EU Samsung Bioepis will assume full responsibility for the commercialization of Byooviz following the transfer of rights from Biogen, effective January 2026 Byooviz was approved by…
October 29, 2025
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