NEWS

Coherus to Highlight Final P-II Study Data of Casdozokitug Regimen to Treat Metastatic Hepatocellular Carcinoma at ASCO-GI 2025

Shots: Coherus will present the P-II trial data of casdozokitug (10mg/kg; IV; Q3W) + Tecentriq (1200mg) + Avastin (15mg/kg) vs PBO for 1L LA/M HCC patients (n=30), in both viral & non-viral diseases, at ASCO GI 2025 Study (as of Sep 2024) met its 1EP of safety & all 2EPs depicting 38% ORR (5…

January 23, 2025

Antennova to Highlight P-I/II (CLINCH) Trial Data of ATN-022 to Treat Advanced/Metastatic Gastric Cancer at ASCO GI 2025

Shots: The company will highlight data from P-I/II (CLINCH) trial of ATN-022 to treat advanced/metastatic gastric cancer in Australia & China at ASCO GI 2025 under the title, ‘Safety and Preliminary Efficacy of ATG-022 in Patients with Advanced/Metastatic Gastric Cancer (CLINCH)’ In the dose expansion phase (as of Nov 2024), 21 patients with CLDN18.2…

January 22, 2025

Solid Biosciences’ SGT-212 Secures the US FDA’s Fast Track Designation for Treating Friedreich’s Ataxia

Shots: The US FDA has granted FTD to SGT-212 for treating Friedreich’s ataxia (FA) and previously approved its IND on Jan 07, 2025 The P-Ib study will assess safety & tolerability of contemporaneous systemic IV and bilateral IDN administration of SGT-212 in non-ambulatory and ambulatory FA patients for 5yrs., with dosing anticipated during H2’25…

January 22, 2025

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Sarclisa with SoC VRd (bortezomib, lenalidomide, & dexamethasone) to treat ASCT-ineligible NDMM patients, following the CHMP’s positive opinion. Regulatory findings are under review in Japan & China Approval was based on a P-III (IMROZ) study assessing Sarclisa + VRd vs VRd, which showed improved PFS of 40% (1EP) with findings reported…

January 22, 2025

Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections

Shots: The US FDA has granted 510(k) clearance & CLIA waiver for Cobas liat STI multiplex assay panels (CT/NG & CT/NG/MG), commercially available under the CE mark in upcoming months The CT/NG (chlamydia & gonorrhea) & CT/NG/MG (chlamydia, gonorrhea & Mycoplasma genitalium) assays compliment the existing portfolio of singleplex & multiplex tests of Cobas liat…

January 22, 2025

ArriVent Biopharma Collaborates with Lepu BioPharma to Develop and Commercialize MRG007 for the Treatment of Gastrointestinal Cancers

Shots: ArriVent & Lepu Biopharma entered into an exclusive license agreement for MRG007, where ArriVent will get rights to develop & market MRG007 (ADC) globally excl. Greater China (mainland China, Hong Kong, Macau & Taiwan) As per the terms, Lepu Biopharma will receive upfront, near-term milestones ($47M cash) & development, regulatory & sales milestones…

January 22, 2025

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

Shots: The US FDA has approved sNDA for Spravato CIII nasal spray to treat MDD patients unresponsive to at least two oral antidepressants, following the FDA Priority Review Approval was based on a multicenter trial that assessed Spravato vs PBO, showing an improved MADRS total score. In a post-hoc analysis, Spravato improved all 10…

January 22, 2025

The US FDA Approves Innovate’s MediBeacon Transdermal GFR System to Evaluate Renal Function

Shots: The US FDA has approved MediBeacon TGFR to assess patients with normal or impaired renal function The system met FDA-approved 1EP of 94% P30 value (% of GFR estimates within ±30% of mGFR) in patients with varied GFR & skin tones. The approval aligns with recent data publication in support of Lumitrace in…

January 21, 2025

Yoltech Initiates a Dose-Escalation Study for YOLT-204 to Treat β -Thalassemia

Shots: Yoltech reported the initiation of a dose-escalation study for YOLT-204 (QD) to evaluate its safety & efficacy as an off-the-shelf treatment of transfusion-dependent beta-thalassemia (TDT) without CT & HSCT In preclinical studies, YOLT-204 showed consistent expression of fetal hemoglobin, associated with reduced polymerization of sickle hemoglobin, fewer complications, & lower mortality. These findings…

January 21, 2025

Junshi Biosciences & LEO Pharma Collaborate to Commercialize Toripalimab in Europe

Shots: Junshi with its subsidiary, TopAlliance, has partnered with LEO to market toripalimab in 32 EU countries incl. EEA, Switzerland & the UK. TopAlliance will remain the authorization holder overseeing development, manufacturing, registration & other activities in the EU LEO Pharma will handle the drug distribution, promotion & sales plus will pay an upfront…

January 21, 2025

NEWS

Coherus to Highlight Final P-II Study Data of Casdozokitug Regimen to Treat Metastatic Hepatocellular Carcinoma at ASCO-GI 2025

Antennova to Highlight P-I/II (CLINCH) Trial Data of ATN-022 to Treat Advanced/Metastatic Gastric Cancer at ASCO GI 2025

Solid Biosciences’ SGT-212 Secures the US FDA’s Fast Track Designation for Treating Friedreich’s Ataxia

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections

ArriVent Biopharma Collaborates with Lepu BioPharma to Develop and Commercialize MRG007 for the Treatment of Gastrointestinal Cancers

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

The US FDA Approves Innovate’s MediBeacon Transdermal GFR System to Evaluate Renal Function

Yoltech Initiates a Dose-Escalation Study for YOLT-204 to Treat β -Thalassemia

Junshi Biosciences & LEO Pharma Collaborate to Commercialize Toripalimab in Europe

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