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Novocure
Novocure Reports MHLW’s Approval of Optune Lua for NSCLC
Shots: Approval of Optune Lua for adults with unresectable advanced/recurrent NSCLC who progressed on Pt-based regimen, was based on P-III (LUNAR) trial assessing it with PD-1/PD-L1 inhibitors or docetaxel (n=145) vs PD-1/PD-L1 inhibitors or docetaxel alone (n=146) Trial showed an mOS (1EP) of 13.2 vs 9.9mos. in the overall population, 19 vs 10.8mos. with Optune Lua +…
September 16, 2025
Bio-Thera and Jamjoom Pharmaceuticals
Bio-Thera Solutions Collaborates with Jamjoom Pharmaceuticals to Commercialize BAT2306 (Biosimilar, Cosentyx)
Shots: Bio-Thera Solutions & Jamjoom Pharmaceuticals have entered into a strategic agreement to commercialize BAT2306, a biosimilar version of Novartis’ Cosentyx (secukinumab) in the Middle East & Africa (MENA) As per the deal, Jamjoom will obtain exclusive MENA rights of BAT2306 to handle regulatory submissions, market access & commercialization, while Bio-Thera will be responsible for development…
September 15, 2025
Akesobio
Akeso Reports First Patient Dosing in P-II (COMPASSION-36) Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma (HCC)
Shots: Akeso has dosed its first patient with cadonilimab + lenvatinib in P-II (COMPASSION-36/AK104-225) trial against lenvatinib for the treatment of advanced HCC in pts previously treated with Tecentriq & Avastin; study is ongoing in the US, EU & China Cadonilimab has also shown superior efficacy in combination regimens, incl. 100% DCR with FOLFOX-HAIC in resectable multinodular HCC…
September 15, 2025
Ionis
Ionis’ ION582 Receives the US FDA’s Breakthrough Therapy Designation to Treat Angelman Syndrome
Shots: The US FDA has granted BTD to ION582 (UBE3A protein expression stimulant) for the treatment of Angelman syndrome Designation was based on P-I/II (HALOS) trial assessing ION582 in pts with Angelman syndrome, which showed improvements across all functional domains incl. communication, cognition & motor function; safety was favorable Additionally, ION582 is being investigated in…
September 12, 2025
Ferring Reports the PMDA’s NDA Acceptance of Nadofaragene Firadenovec to Treat BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)
Shots: Japan’s PMDA has accepted the NDA of nadofaragene firadenovec (intravesically; Q3W) for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS ± papillary tumors (Ta/T1) NDA was backed by P-III study evaluating nadofaragene in 157 pts, where 5yr. follow-up data showed OS rate of 80% & a 49% cystectomy-free survival in adults with CIS…
September 12, 2025
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