Regulatory Index News w/c 11 November 2019

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


Survey shows “lack of knowledge” about diabetes risks

Just in time for World Diabetes Day a new survey conducted by Merck and YouGov has found that there is a need to better educate people on the risk factors of type II diabetes. The research revealed that more than half of the public are not aware the condition may be preventable.

To read more follow this PharmaTimes link


Regenxbio, stung by trial hold on gene therapy, sues FDA

Regenxbio, facing regulatory delays for two of its gene therapy programs, has sued the Food and Drug Administration in hopes of overturning the agency's decision to halt enrollment into one study and stop dosing in a second. 

To read more follow this BioPharmaDive link


ICER draws new gene therapy pricing framework

The Institute for Clinical and Economic Review on Tuesday said it will assess the value of pricey one-time and short-term curative treatments like gene therapies differently from standard drugs taken chronically because of uncertainties over both their costs and benefits over time.

To read more follow this BioPharmaDive link


NICE ‘OK’ for Sativex in MS

The National Institute for Health and Care Excellence (NICE) has recommended Bayer’s Sativex (delta-9 tetrahydrocannabinol (THC) cannabidiol (CBD)), for spasticity in people with multiple sclerosis (MS).  The cannabis-based medicinal product has been approved within its licensed indication, as the organisation deemed it clinically and cost effective at its current list price.

To read more follow this PharmaTimes link


AZ releases positive anifrolumab data

AstraZeneca has announced positive results from its Phase III TULIP 2 trial, evaluating anifrolumab in moderate to severe systemic lupus erythematosus (SLE).  The drug demonstrated superiority across multiple efficacy endpoints versus placebo, with both arms receiving standard of care.

To read more follow this PharmaTimes link


Merck wants to know if taking out cellular trash can treat Alzheimer's

Like many of its peers, Merck has pulled back from neuroscience drug development as clinical failures — from pain to depression to Alzheimer's — continued to pile up across the industry. The Calporta acquisition, though, provides evidence that Merck remains interested in the field's most prized disease targets.

To read more follow this BioPharmaDive link




Lorna Osborn

Date Published

14th November 2019

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