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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
J.P. Morgan Special: Dealmaker of the Year 2024 (Part 02)
Shots: In this second installment of Dealmaker 2024, PharmaShots presents an insightful guide to the top M&A deals ranked by deal value This report highlights Novo Nordisk’s remarkable achievements, including 24 collaborations spanning acquisitions, company formations, contract services, development and commercialization agreements, facility purchases, licensing options, and platform/product purchases. Collectively, these deals amount to…
January 15, 2025
Hutchmed
HUTCHMED’ Orpathys (Savolitinib) Receives the NMPA’s Full Approval for Locally Advanced or Metastatic MET Exon 14 NSCLC
Shots: The NMPA has granted sNDA approval of Orpathys to treat locally advanced or metastatic NSCLC with MET exon 14 skipping alterations, expanding its indication to include both treatment-naïve & experienced patients. Previous conditional approval is also converted to full approval Approval was based on P-IIIb study, with preliminary data from the first line…
January 15, 2025
Neurogen Partners with Linus Health to Develop Early Detection Technology for Mild Cognitive Impairment and Dementia due to Alzheimer’s Disease
Shots: Neurogen Biomarking partnered with Linus Health to form a unified platform by incorporating the latter’s digital cognitive assessments with the Neurogen Biomarking ecosystem, commercially available in Q1’25 The new platform will integrate early detection & care for patients with MCI or dementia related to AD with Linus Health’s scientifically validated assessments to identify…
January 15, 2025
Regeneron New
Regeneron Reports Interim Data from P-III (C-POST) Trial of Libtayo Adjuvant to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)
Shots: The P-III (C-POST) trial assessed Libtayo adj. (n=205; 350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.) vs PBO (n=204) to treat high-risk CSCC patients (N=415) for ~48wks. Study met its first prespecified interim analysis, showing 68% reduced disease occurrence & death risk at 24mos. median follow-up, with additional…
January 15, 2025
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