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NEWS

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

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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

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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

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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

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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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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (December 30th, 2024 – January 03rd, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below:     Novartis Reports Data from P-III (STEER) Study of Onasemnogene Abeparvovec to Treat Children and Young Adults with Spinal Muscular Atrophy (SMA) Read More: Novartis CARsgen Therapeutics Reports Topline Results from P-II…
January 3, 2025

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Atavistik Bio Partners with Pfizer to Discover Novel Precision Allosteric Therapeutics

Shots: Atavistik Bio has signed a research collaboration with Pfizer to discover novel precision allosteric therapies for significant unmet medical needs As per the terms, Atavistik Bio will identify allosteric binders for Pfizer’s 2 undisclosed targets, with Pfizer having the option to license the programs post research. Financial terms are undisclosed The alliance…
January 3, 2025

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Pharmanovia Collaborates with Radius Health to Commercialize Abaloparatide for Osteoporosis Treatment

Shots: Pharmanovia has signed an exclusive in-licensing agreement with Radius Health for abaloparatide (US brand name: Tymlos) to treat osteoporosis, expanding its osteoporosis franchise Pharmanovia will handle clinical, regulatory & commercial responsibilities across APAC region (China, Singapore, Thailand, Indonesia, Vietnam, Taiwan, Hong Kong, Malaysia, Macau & Philippines), while Radius will get an upfront, regulatory…
January 3, 2025

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