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    FDA Approves First Automated Insulin Delivery Device

    The US Food and Drug Administration (FDA) on Wednesday approved Medtronic’s artificial pancreas, known as the MiniMed 670G hybrid closed looped system, which is the first device approved in the US to automatically monitor glucose and provide appropriate basal insulin doses in people 14 and older with type 1 diabetes. The system is intended to adjust insulin levels with little or no input from the user, and works by measuring glucose levels every five minutes and automati...
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    UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that patients with diabetes using Roche’s Accu-Chek Insight insulin pump should be careful when inserting pre-filled insulin cartridges as Roche has reported an increasing number of instances when patients experienced leaking insulin cartridges. “Users of Accu-Chek Insight insulin pump system with NovoRapid PumpCart cartridges, can check for any leaked insulin in the cartridge compartment...
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    Asia Regulatory Roundup: India Allows Parallel Submission of Trial Filings for Insulins, mAbs (9 August 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Allows Parallel Submission of Clinical Trial Filings for Insulins, mAbs The Drug Controller General of India (DCGI) has cleared clinical trial sponsors to submit applications to his office and the Review Committee on Genetic Manipulation (RCGM) simultaneously. By moving from sequential to parallel filings, DCGI has potentially shortened the time it takes for de...
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    Korean Device Firm Denies FDA Inspection

    A South Korean insulin syringe and pen needle manufacturer on Wednesday became the fifth foreign company to currently have its products banned from entry into the US after denying an inspection by the US Food and Drug Administration (FDA). Seoul, Korea-based MedExel Medical Manufacturing Co., which manufactures insulin syringes and insulin pen needles in Korea, joined Taiwan’s Morris Engineering Works, India’s Sewa Medicals, and China’s Intop Tech and Shanghai Realov E...
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    EMA Updates its Biosimilar Insulin Guideline

    The European Medicines Agency (EMA) has updated its guideline on the requirements for clinical and non-clinical development of biosimilar insulin products. The update expands the scope of the original document and gives additional detail on study design parameters. Biosimilar Medicinal Products in the EU EMA recently finalized its guideline on “similar biological medicinal products”—commonly referred to as biosimilars—which will enter into effect in April 2015. B...
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    Citing Disease Transmission Risk, FDA to Require Stronger Labels on Some Diabetes Injectors

    The US Food and Drug Administration (FDA) said it will require manufacturers of multi-dose diabetes pen devices to label their products with more prominent warnings that patients should not share the devices. In a 25 February 2015 safety announcement, FDA said the new warnings are meant to "reduce the serious risk of infection" when users share insulin pens and other injectable diabetes medications, "even [when] the needle is changed." "Sharing pens can result in the sp...