AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Bydureon® BCise™ (exenatide extended-release) injectable suspension, a new formulation of Bydureon (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycemic control.
Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0 in favour of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. One member of the committee abstained.
The pill form of the drug semaglutide is worth pursuing as a way to control blood sugar in patients with type 2 diabetes, say researchers.
Boston-based Intarcia Therapeutics became the latest casualty of the FDA’s manufacturing standards. The agency has rejected Intarcia’s implanted diabetes drug/device, which company execs have long insisted is on a straight path to blockbuster sales.
Novo Nordisk announced that the China Food and Drug Administration (CFDA) has approved Tresiba® (insulin degludec) for the treatment of diabetes in China. Tresiba® is a new-generation, once-daily basal insulin with an ultra-long duration of action which allows for flexibility in day-to-day dosing.
Sanofi announced that the U.S. Food and Drug Administration (FDA) granted tentative approval for Admelog® (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog. Admelog is indicated to improve glycemic control in adults and children with diabetes mellitus.
Nemaura Medical Inc. (NMRD), a medical technology company focused on the development and commercialization of sugarBEAT®, a wireless adhesive skin-patch for adjunctive use by diabetics as a non-invasive and needle-free continuous glucose monitoring (CGM) system announced today that it has completed development of a medical grade app prepared and verified in accordance with ISO13485 quality systems and the appropriate medical devices directives, and designed to be used with the sugarBEAT® device or with glucose meters and strips to display glucose levels on users android mobile devices.
Growth in prescriptions for diabetes medicines is exceeding the rise in overall prescribing, according to new figures from NHS Digital.
Novo Nordisk’s diabetes drug Victoza is now approved in Europe as the only GLP-1 analogue with a label including prevention of cardiovascular events.
The US Food and Drug Administration has given a tentative green light to Merck & Co’s follow-on biologic basal insulin Lusduna Nexvue.
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