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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 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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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 has reported CE Mark approval of TactiFlex Duo Ablation Catheter, Sensor Enabled to treat pts with atrial fibrillation (AF)
Approval was based on the global FOCALFLEX CE Mark study assessing TactiFlex Duo, which showed clinically meaningful efficacy & favorable safety in the AF pts
Also being evaluated in the FLEXPULSE IDE trial in the…
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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 has entered into a definitive agreement to acquire Exact Sciences, making Exact a subsidiary of Abbott upon deal completion
As per the deal, Abbott will acquire Exact Sciences for $105 per share, representing a total equity value of ~$21B & an estimated enterprise value of $23B, with financing that includes absorbing Exact’s ~$1.8B in…
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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 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 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 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…

