Regulatory Index News w/c 14 January 2019

Here is a selection of this week's latest news from around the world


European Commission approves Opdivo for advanced renal cell carcinoma

The European Commission has approved Bristol-Myers Squibb's Opdivo in combination with low-dose Yervoy for first-line treatment of patients with intermediate and poor risk advanced renal cell carcinoma (RCC).

To read more follow this PharmaTimes link 


How a 'regulatory dead zone' may be holding up copycat insulin

The insulin market has increasingly attracted scrutiny from politicians, regulators and patient groups, as prices ramp higher for the hormone that millions of diabetics depend on to stay alive.

To read more follow this BioPharmaDive link


Amgen's osteoporosis drug faces safety scrutiny from FDA

Food and Drug Administration staff appeared open to a narrow approval for Amgen's osteoporosis drug Evenity in documents published Monday which weighed the treatment's efficacy against safety concerns about its cardiovascular risk. 

To read more follow this BioPharmaDive link


‘Innovative’ new disease and infection test

Queen’s University researchers have developed a new test to detect disease and infection that could save time, money and possibly lives.

To read more follow this PharmaTimes link 




New breast cancer testing tool in development

A study carried out by researchers from the University of Cambridge, National Cancer Institute, National Institutes of Health in the US among others has shown how putting different genetic and risk factor data into a prediction equation could help us understand how likely a woman is to develop breast cancer.

To read more follow this PharmaTimes link 


7 biopharma trends to watch in 2019

Bristol-Myers Squibb's splashy $74 billion Celgene buy is set to reset the top ranks of pharma, but the industry's year ahead will be shaped more directly by larger trends impacting the sector's perception, investment and future growth.

To read more follow this BioPharmaDive link




Lorna Osborn

Date Published

17th January 2019

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