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Abbott
NEWS
Abbott Receives the European CE Mark for Esprit BTK System to Treat Peripheral Artery Disease Below the Knee
Shots: Abbott has received European CE Mark approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System to treat people with peripheral artery disease (PAD) below the knee (BTK) Esprit was evaluated in the LIFE-BTK trial against balloon angioplasty in pts (n >260) with PAD BTK, which showed sustained efficacy & ability to open vessels…
August 27, 20250Comments
Regeneron New
NEWS
Regeneron Reports P-III (NIMBLE) Trial Data of Cemdisiran for Generalized Myasthenia Gravis (gMG)
Shots: The P-III NIMBLE trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to cemdisiran (600mg, SC, Q12W, n=64), cemdi-poze (SC, Q4W, n=67), or PBO (n=59), with completion rates of 100%, 96%, & 90%, respectively; FDA’s filing is expected in Q1’26, pending discussions Trial met its 1EP of improved MG-ADL total score, showing…
August 27, 20250Comments
New Drug Designations: July 2025
INSIGHTS+
New Drug Designations: July 2025
Shots:       PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA.    The July 2025 edition covers designations awarded to 47 drugs and 3 medical devices, comprising 23 small molecules, 9 biologics, 8 cell and gene therapies, and…
August 26, 20250Comments
NEWS
BioArctic and Novartis sign agreement for BrainTransporter ~$802M
Shots: BioArctic has entered into an option, collaboration, and license agreement with Novartis to develop a neurodegeneration treatment using BrainTransporter As per the deal, BioArctic receives $30M upfront and could earn up to $772M in milestones plus tiered mid-single-digit royalties if Novartis licenses and commercializes the drug BioArctic will develop a drug candidate using BrainTransporter and a Novartis…
August 26, 20250Comments