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Roche
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
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
InnoCare and KeyMed Together Partner with Prolium Bioscience to Develop ICP-B02
Shots: InnoCare & KeyMed together have signed an exclusive license agreement with Prolium to develop & commercialize ICP-B02 (CM355) Prolium gains exclusive rights to develop, manufacture & commercialize ICP-B02 globally (non-oncology) and in ex-Asia regions (oncology) while InnoCare & KeyMed will get a total of ~$520M (upfront & near-term payments), minority equity stake in…
January 21, 2025
Formycon Reports the EC’s Approval of FYB203 (Biosimilar, Eylea) Under the Brand Names Ahzantive and Baiama
Shots: Formycon & Klinge Biopharma have reported the EC’s approval of FYB203, biosimilar of Eylea (aflibercept), under the brand names: Ahzantive & Baiama valid across the EU plus Iceland, Liechtenstein & Norway after receiving the CHMP’s recommendation in Nov 2024 The biosimilar is intended to treat Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other…
January 21, 2025
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