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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (January 13, 2025 – January 17, 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:     Bayer Reports Topline Data from P-III (QUANTI) Trials of Gadoquatrane for its Use in MRI Read More: Bayer Oryzon Reports Dosing of the First Patient with Iadademstat + Venetoclax + Azacitidine…
January 17, 2025

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Ceva Animal Health Partners with Touchlight to Use its dbDNA Technology in Animal Healthcare

Shots: Ceva & Touchlight entered into an agreement & long-term collaboration for developing & manufacturing future animal health products, integrating the former’s development & marketing expertise with Touchlight’s dbDNA tech to develop DNA vaccines As per the agreement, Touchlight is entitled to upfront payment, development milestones & sales-based royalties, while the complete financial terms…
January 17, 2025

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Biothera and World Medicine Partners to Commercialize BAT2206 (Biosimilar: Ustekinumab) in Turkey

Shots: Bio-Thera & World Medicine entered into an exclusive license & commercialization agreement for BAT2206, a biosimilar to Janssen’s Stelara (ustekinumab), leveraging World Medicine’s marketing expertise & distribution network in Turkey As per the terms, World Medicine will hold market approval of BAT2206 in Turkey as well as its registration, imports, promotion & marketing, while…
January 17, 2025

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Innovent and Ask Biopharma Receives China’s NMPA Approval for Limertinib to Treat Non-Small Cell Lung Cancer

Shots: NMPA approved limertinib (oral EGFRm TKI) to treat LA/M EGFR T790M-mutated NSCLC in adults, based P-IIb trial assessing limertinib in (n=301) NSCLC patients This study showed 68.8% ORR, 92.4% DCR, plus 11mos. mPFS with 11.1mos. mDoR. It also showed ORR & mPFS of 65.9% & 10.6mos., respectively in patients with assessable CNS lesions…
January 17, 2025

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Sutter Health Collaborates with GE HealthCare to Enhance Patient Care Through AI-Powered Imaging for Physicians and Clinicians

Shots: Sutter Health and GE HealthCare signed a 7yrs. strategic collaboration agreement (Care Alliance), to enhance access to imaging services for patient and clinician experiences in California. This will enable faster appointments, quicker imaging results, and more consistent care Sutter Health's key initiatives include a fast technology program to deploy advanced AI imaging tools…
January 17, 2025

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Silexion Therapeutics Reports Preclinical Data for SIL-204 in Combination with 1L Chemotherapies for Pancreatic Cancer

Shots: Silexion reported preclinical data of SIL-204 (siRNA agent) + 5-fluorouracil + irinotecan & SIL-204 + gemcitabine combinations in KRAS G12D mutated human pancreatic tumor cell lines The data demonstrated a reduction in cancer cell confluence in contrast to 1L CT agents alone, where SIL-204 + 5-fluorouracil + irinotecan achieved reduction after 3 days…
January 16, 2025

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NEXTBIOMEDICAL Secures the US FDA’s IDE Approval of Nexsphere-F to Use it in Genicular Artery Embolization (GAE) for Knee Osteoarthritis

Shots: The US FDA has granted IDE approval to initiate RESORB clinical evaluation of Nexsphere-F for knee osteoarthritis. It is CE-MDD approved for arthritis embolization & has shown superior efficacy in various musculoskeletal embolization cases across Asia & the EU RESORB study will evaluate the efficacy of Nexsphere-F to ease pain & improve mobility…
January 16, 2025

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REGENXBIO Join Forces with Nippon Shinyaku to Develop and Commercialize RGX-121 and RGX-111 for Mucopolysaccharidosis (MPS)

Shots: REGENXBIO & Nippon have partnered to develop RGX-121 (Hunter syndrome; FDA’s accelerated approval expected in late 2025, with ongoing rolling BLA filing) & RGX-111 (P-I/II study for Hurler syndrome) in the US & Asia. The closing is expected in Q1’25 REGENXBIO will get $110M upfront, ~$700M milestones ($40M development & regulatory + $660M…
January 15, 2025

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