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NEWS
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, 20250Comments
NEWS
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, 20250Comments
NEWS
VarmX Inks a ~$2.2B Strategic Collaboration and Option Agreement with CSL for VMX-C001 to Advance Coagulation Treatment
Shots: VarmX has collaborated with CSL to advance its lead asset, VMX-C001 (commercial launch expected in 2029), & granted CSL an exclusive option agreement with its shareholders to acquire all issued & outstanding shares of the company As per the collaboration, CSL will fully fund the global P-III (EquilibriX-S) trial of VMX-C001 in FXa DOAC…
September 16, 20250Comments
NEWS
Monte Rosa Therapeutics Enters a ~$5.7B with Novartis to Develop Degraders for Immune-Mediated Diseases
Shots: Monte Rosa has collaborated with Novartis to develop novel degraders for immune-mediated diseases, leveraging Monte Rosa’s QuEEN discovery engine As per the deal, Novartis will gain an exclusive license to an undisclosed discovery target & options to license 2 programs from Monte Rosa’s preclinical immunology portfolio The deal is valued at ~$5.7B, with Monte…
September 16, 20250Comments
Mehul Desai from Enable Injections in a Riveting Conversation with PharmaShots
VIEWPOINTS
Wearable Drug Delivery System: Mehul Desai from Enable Injections in a Riveting Conversation with PharmaShots 
Shots:  Enable Injections recently shared survey findings indicating that many oncology assets with strong commercial potential are often prematurely abandoned or deprioritized due to challenges in formulating small volumes (<3 mL) for subcutaneous delivery.  To address this need, Enable Injections developed enFuse, an innovative, hands-free, wearable drug delivery platform with a discreet, hidden needle that…
September 15, 20250Comments
Bio-Thera and Jamjoom Pharmaceuticals
NEWS
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, 20250Comments
Akesobio
NEWS
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, 20250Comments