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Abbott

Abbott Secures FDA Authorization for Libre Duo 10 Day, a Dual Glucose-Ketone Sensing Technology

Shots: FDA has approved Libre Duo 10 Day, a dual glucose-ketone sensing biowearable, to provide real-time glucose monitoring while continuously detecting rising ketones for diabetic ketoacidosis (DKA) emergency, with launch expected later this year Libre Duo 10 Day met FDA standards for both integrated continuous glucose monitoring (iCGM) & the new integrated continuous glucose &…

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Avricore Health’s HealthTab Enters Multi-Year Collaboration with Abbott to Expand Point-of-Care Testing Across the UK

Shots: Avricore Health’s HealthTab entered a multi-year collaboration agreement with Abbott to supply and distribute Abbott’s point-of-care testing products through the HealthTab platform across the UK, supporting the expansion of pharmacy-based testing. Under the agreement, HealthTab will distribute Abbott’s Afinion 2 Analyzer through NHS-linked pharmacies for HbA1c and lipid profile testing, while establishing a framework…

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Abbott

Abbott Receives ANVISA’s Approval for Two Denosumab Biosimilars (Biosimilars, Prolia and Xgeva) 

Shots:  The ANVISA has approved two denosumab biosimilars (60 mg and 120 mg), a biosimilar version of Prolia and Xgeva in Brazil, expanding access to treatments for osteoporosis and cancer-related bone complications  The P-III SIMBA study confirms that Abbott's MB09 denosumab biosimilar demonstrates efficacy and safety comparable to the reference biologic, providing equivalent protection against bone loss in postmenopausal women  In 2023, mAbxience and Abbott partnered to develop, manufacture, and supply denosumab biosimilars,…

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Abbott

Abbott Reports FDA Clearance and CE Mark Approval of its Amplatzer Piccolo Delivery System for Premature Babies with a Hole in the Heart

Shots: Abbott has received the US FDA clearance & European CE Mark for its Amplatzer Piccolo Delivery System, used with Amplatzer Piccolo Occluder, to treat premature babies (≥2lbs) with patent ductus arteriosus (PDA; hole in the heart) Approved in the US & EU in 2019, Amplatzer Piccolo Occluder is a minimally invasive transcatheter device, smaller…

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Abbott

Abbott Receives Health Canada’s Approval for Esprit BTK System to Treat Chronic Limb Threatening Ischemia Below the Knee

Shots: Abbott has received Health Canada’s approval for the Esprit BTK Everolimus Eluting Resorbable Scaffold System to treat people with chronic limb-threatening ischemia (CLTI) below the knee (BTK) Esprit was evaluated in the LIFE-BTK trial against balloon angioplasty, which showed improved patient outcomes, with 48% fewer repeat procedures over the study period. Data was highlighted…

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Abbott

Abbott’s Navitor TAVI System Receives European CE Mark for Aortic Stenosis in Patients at Low or Intermediate-Risk for Surgery

Shots: Abbott has received the CE Mark approval for Navitor transcatheter aortic valve implantation(TAVI) system to expand its use in people with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery Approval was backed by VANTAGE study of Navitor TAVI, which met its safety & efficacy 1EPs in above pts Trial showed…

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Abbott

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…

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Abbott

Abbott Reports the Approval for its Denosumab Biosimilar in Thailand 

Shots:  Abbott has secured regulatory approval for its denosumab biosimilar in Thailand, increasing access to advanced treatments for osteoporosis and cancer-related bone loss  Denosumab is a mAb that works by targeting RANKL, which regulates bone metabolism & osteoclast formation   Abbott will offer denosumab as part of its strategy to expand access to quality medicines in…

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