Regulatory Index News w/c 15 July 2019

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


Novartis secures speedy review for sickle cell drug

An experimental sickle cell disease drug developed by Novartis could win U.S. approval by early next year, after the Food and Drug Administration granted the Swiss pharma's application a speedy regulatory review.

To read more follow this BioPharmaDive link


Roche’s Genentech inks deal with Sosei Heptares

Sosei Heptares has announced a multi-target research collaboration and license agreement with Genentech, a member of the Roche Group, to discover and develop novel medicines that modulate G protein-coupled receptor (GPCR) targets of interest to Genentech.

To read more follow this PharmaTimes link


‘World’s most accurate blood test’ launched in UK

MDNA Life Sciences has announced that its Mitomic Prostate Test (MPT) – the world’s most accurate blood test to determine whether a man does or does not have prostate cancer that requires treatment – is now available for clinical use with the launch of the test in the UK by MDNA’s partner, Aspire Pharma.

To read more follow this PharmaTimes link


Billion-dollar settlement gets Reckitt out of federal opioid probes

British consumer drug company Reckitt Benckiser said it will pay up to $1.4 billion to settle all federal investigations related to the marketing of the opioid-dependence product Suboxone film by former subsidiary Indivior. 

To read more follow this BioPharmaDive link


Merck urges caution on use of its newly approved antibacterial

The Food and Drug Administration on Wednesday approved Merck & Co.'s triple antibacterial Recarbrio for treatment of complicated urinary tract and abdominal infections caused by one of 16 different strains of bacteria.

To read more follow this BioPharmaDive link


NICE U-turn for Kisqali in breast cancer

The National Institute of Health and Care Excellence (NICE) has recommended Novartis’ Kisqali (ribociclib) for use on the NHS in combination with fulvestrant, where exemestane plus everolimus is the most appropriate alternative.

To read more follow this PharmaTimes link




Lorna Osborn

Date Published

18th July 2019

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