Regulatory Index News: 23/11/2017

Welcome to another Regulatory Index News digest today. The next big step for the EMA has been taken, take a read here to see what was decided.

A new home for the EMA secured in Amsterdam

Following months of uncertainty for the European Regulators due to Brexit, Amsterdam has been confirmed as the new location for the EMA. Nineteen cities across Europe battled to host the prestigious regulatory agency for its specialist jobs, families and business, with a close second place for Milan, Spain. The agency now has just 16 months to move from Canary Wharf, where they have resided since their inception in 1995, to the well-equipped city by March 30th, 2019. The agency has over 900 staff currently employed so this will prove no small feat to transition them into new housing, schools and job placements. If you would like to read more on this big decision, please click here for a BioPharmaDIVE article.

Concordia price-hikes receive scrutiny

Concordia stand accused of breaking UK competition laws by overcharging the NHS using its dominant position with an essential thyroid drug. Following a pricing investigation by the UK’s Competition and Markets Authority, it was found that the NHS spent over £34 million on liothyronine tablets last year, where the price had risen from £4.46 in 2007 to a staggering £258.19 in 2017. This has arisen due to the de-branding of the product in 2007, as there is no country cost-limiting governance for unbranded medicines, meaning the company can charge what they desire without restriction. These findings are only provisional so there is still no definitive decision of competition law infringement. Please click here if you would like to read more from a PharmaTimes article.

US approval for GSK’s landmark 2-drug HIV treatment

The FDA have just approved the first two drug complete treatment regimen for HIV, Juluca, which combines the two drugs, dolutegravir and rilpivirine. This goes up against the standard three or more drug therapies for HIV and it is said that the reduced drugs, means that there is likely to be a reduction in toxicity for patients. The drug list price has still not been disclosed but it is expected that this regimen may also limit costs. Juluca’s approval may provide some unwanted competition for the HIV-invested Gilead who are currently chasing a three-med trifecta approval. If you would like to look further into this, please click here for a FiercePharma article. 

M L

Author

Max Lymbery

Date Published

23rd November 2017

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