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Merck and Daiichi Sankyo’s Raludotatug deruxtecan Receives FDA’s Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers 
Shots: The US FDA has granted BTD to Raludotatug deruxtecan (R-DXd) for the treatment of adults with Pt-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with Avastin Designation was based on P-I trial (n=179) & the ongoing P-II/III (REJOICE-Ovarian01) trial (n=~710), with subgroup analysis of P-I presented at…
September 16, 2025
Womed Reports the US FDA’s Approval of Womed Leaf to Treat Asherman Syndrome
Shots: The US FDA has approved the PMA application of Womed Leaf for women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions (Asherman syndrome); commercial launch expected in early 2026 Womed Leaf was evaluated in the PREG2 trial (n=160) for mod. to sev. intrauterine adhesions, showing reduced severity of intrauterine adhesion after hysteroscopic…
September 16, 2025
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
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