Regulatory Index News: 30/03/2018

Welcome to your Regulatory News update today. Read here for a novel US approval, upcoming purchase and draft legislation proposals.

Dexcom rewarded FDA approval for integrated glucose monitor and insulin dosing device

Dexcom has received FDA approval for their continuous glucose monitor (CGM) integrated with insulin pumps and other diabetes devices, known as G6, marking the first FDA approval for an integrated system. G6 is a wearable patch which takes continuous blood glucose measurements that are wirelessly transmitted to a connected device. The integrated device can now react to these readings to enable automatic insulin delivery in response to raised blood glucose, with a range of compatible medical devices. This opens up the pathway to other integrated CGMs (Class II devices) with the FDA ‘taking steps’ to expedite their review of similar devices. Dexcom are now working on the next version of the device, which is expected to last 14 days rather than the current 10. Please click here to read more from a FiercePharma article.

GSK to make $13 billion purchase of Novartis consumer healthcare joint venture

GSK are to buy Novartis out of their consumer healthcare joint venture for $13 billion in order to take control of power brands such as Sensodyne, Panadol, Voltaren and Nicotinell. This comes briefly after the public pull-out of the auction for Pfizer’s consumer business, which was anticipated to be sold for up to $20 billion. On top of this, GSK has stated that it will be strategically reviewing Horlicks and other consumer nutrition products. Novartis on the other hand have released statements that they will use the money to expand their business both organically and through bolt-on acquisitions. If you would like to read more on this story, please click here for a Reuters article.

Legislation looks to tackle the US opioid crisis by limiting prescription length

The US Senate Health Committee chairman, Lamar Alexander, has offered drafts of two pieces of legislation aimed to tackle the opioid crisis. The first is designed to make it simpler for doctors to write prescriptions for smaller numbers of opioids, which is expected to aid in the reduction of over-prescribing the medication. On top of this, the proposal is calling for manufacturers to provide safe ways to dispose of leftover drugs and packaging. The second draft legislation is designed to improve collaboration between the FDA and the Customs Border Protection in hope that it aids in seizing illegal drugs such as fentanyl. Please click here if you would like to read further from a BioPharmaDIVE article.



Max Lymbery

Date Published

30th March 2018

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