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Amgen
News
Amgen Receives EC’s Approval for Blincyto to Treat Philadelphia Chromosome-Negative CD19-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)
Shots:The EC has approved Blincyto monotherapy as a part of consolidation therapy to treat 1L philadelphia chromosome-negative CD19+ B-ALL adults based on P-III (E1910) trial Blincyto + CT showed improved OS with 4.5yrs. median follow up vs CT alone, whereas 5-yrs. mFU demonstrated 82.4% vs 62.5% OS in 112 pts The trial was led by…
January 30, 20250Comments
News
Life Spine Receives US FDA’s 510(k) Clearance for ProLift Pivot Expandable Spacer System
Shots:The US FDA has granted 510(k) clearance to Prolift Pivot expandable spacer system, expanding Life Spine’s Micro Invasive tech portfolio The system provides full articulation for precise spinal fusion, while reducing tissue disruption & nerve retraction, allowing surgeons to restore patient alignment with superior control & efficiency. It also features OSSEO-LOC surface tech that promotes osseointegration & long-term…
January 30, 20250Comments
Roche
News
Roche Reports Topline Data from P-III (INAVO120) Trial of Itovebi (Inavolisib) to Treat HR-Positive Breast Cancer
Shots:The P-III (INAVO120) trial evaluated Itovebi + Ibrance + fulvestrant vs matching PBO in PIK3CA-mutated, HR+/HER2-, endocrine-resistant, 1L LA/M breast cancer pts (n=325); ongoing regulatory review in EU & other regions Study met its 2EP of significant OS demonstrating 57% reduction in risk of disease worsening or death (mPFS: 15 vs 7.3mos.; HR=0.43).…
January 30, 20250Comments
News
Lantheus Holdings to Acquire Evergreen Theragnostics for ~$1B
Shots:Lantheus will acquire Evergreen Theragnostics for $250M upfront plus ~$752.5M development & sales milestones related to Octevy & other assets in an all-cash transaction, with closing anticipated in H2’25 pending regulatory approvals The acquisition will add Evergreen’s Octevy (registrational-stage PET imaging agent for somatostatin receptor +ve NETs in adults & pediatrics) complementing Lantheus'…
January 29, 20250Comments
Fresenius Kabi
News
Fresenius Kabi Reports the US FDA’s 510(k) Clearance for Adaptive Nomogram, Improving Plasma Collection Efficiency
Shots:The US FDA has granted 510(k) clearance to Adaptive Nomogram algorithm in the Aurora Xi Plasmapheresis System to improve plasma collection efficiency Clearance was based on a trial of Adaptive Nomogram in Aurora Xi Software Version 2.0 vs the existing Optimized Nomogram involving >52,400 procedures that met its 1EP, depicting increased plasma volume…
January 29, 20250Comments

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