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GlycoNex Reports Licensing Agreement to Develop SPD8 (Biosimilar, Prolia and Xgeva)
Shots: GlycoNex has reported a licensing agreement to develop SPD8, a biosimilar version of Amgen’s Prolia and Xgeva (denosumab) The licensee will secure rights for the development, regulatory activities & commercialization of SPD8 in the designated regions. The deal includes development and commercial milestones, supporting GlycoNex's global business operations SPD8 is under P-III…
January 7, 2025
Hologic Completes the Acquisition of Gynesonics for ~$350M
Shots: Hologic has completed the acquisition of Gynesonics, focused on developing minimally invasive women’s health solutions, for ~$350M The acquisition has strengthened Hologic's portfolio with the addition of Sonata System, a minimally invasive solution for heavy periods & fibroids The Sonata System is developed to capture intrauterine images for diagnosis and transcervical treatment…
January 7, 2025
Absci Corporation Collaborates with Invetx to Develop AI-Based Drug Creation Platform for Animal Health
Shots: Absci Corporation & Invetx have entered into a strategic collaboration to develop an innovative Half-Life Extension platform for animal health The alliance will leverage Absci’s generative AI models to develop modular antibody sequences in animals, while Invetx gains rights to use HLE platform for improving therapeutic effect duration & customer convenience of various…
January 7, 2025
Fortress Biotech and Cyprium Therapeutics Report the US FDA’s NDA Acceptance with Priority Review of CUTX-101 to Treat Menkes Disease
Shots: Fortress and its subsidiary, Cyprium, have reported the US FDA’s NDA acceptance & priority review of CUTX-101 (copper histidinate) to treat Menkes disease, with the decision expected on Jun 30, 2025 Submission was based on a trial of CUTX-101 vs untreated historical control that depicted significantly improved OS & an 80% reduction in…
January 7, 2025
Stryker to Acquire Inari Medical for ~$4.9B
Shots: Stryker has signed a definitive agreement to initiate a tender offer for acquiring all the issued & outstanding shares of Inari Medical for $80 per share in cash, making it a total value of ~$4.9B Upon completion, Stryker will acquire remaining shares in a second-step merger at the same price. The deal is…
January 7, 2025
Ultragenyx Reports the EC’s Approval of Evkeeza (evinacumab) to Treat 6-Months Old Children with Homozygous Familial Hypercholesterolemia (HoFH)
Shots: The EC has approved Evkeeza (an angiopoietin-like 3 inhibitor), as an adjunct to diet & other lipid-lowering therapies, to treat children (6mos. to 5yrs.) with HoFH Approval was based on model-based analysis that predicted similar or greater LDL-C reductions with Evkeeza (15mg/kg, Q4W) in children (6mos. to 5yrs.) at 24wks. Data from compassionate…
January 6, 2025
NMD Pharma’s NMD670 Secures the US FDA’s Orphan Drug Designation to Treat Charcot-Marie-Tooth Disease
Shots: The US FDA has granted ODD to NMD670 for treating Charcot-Marie-Tooth disease (CMT). It is small molecule that inhibits CIC-1 to enhances muscle responsiveness, improving neuromuscular transmission & restoring function NMD670 (PO, BID) is under P-IIa (SYNAPSE-CMT) evaluation for its efficacy, safety & tolerability in adults (n=80) with CMT1 or CMT2 subtype for over…
January 6, 2025
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