Regulatory Index News w/c 26 August 2019

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


FDA issues safety warning for newer hepatitis C drugs following patient deaths

The Food and Drug Administration identified dozens of cases in which patients who weren't supposed to take a newer kind a hepatitis C medication did, and then got sicker, leading the agency to issue a safety warning.

To read more follow this BioPharmaDive link


Empliciti combo bags EU approval for multiple myeloma

Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies.

To read more follow this PharmaTimes link


FDA green light for Fasenra

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of eosinophilic oesophagitis (EoE), AstraZeneca has announced.

To read more follow this PharmaTimes link


AstraZeneca gets lupus win but past failure could slow progress

AstraZeneca on Thursday said its lupus drug anifrolumab succeeded in a Phase 3 trial, scoring "statistically significant and clinically meaningful" reductions in disease activity among 373 patients.

To read more follow this BioPharmaDive link


Amyloid's last hope? Prevention studies next big test for Alzheimer's research

A study set to read out early next year could be the final curtain for an Alzheimer's disease hypothesis that has prevailed for more than 20 years — or it could spur a re-evaluation of why past efforts failed.

To read more follow this BioPharmaDive link


NICE updates hypertension guideline

The National institute for Health and Care Excellence (NICE) has published an updated guideline on the diagnosis and treatment of hypertension. The organisation has announced that the final guideline confirms the lower CVD risk threshold at which treatment for hypertension should be considered, in discussion with patients.

To read more follow this PharmaTimes link




Lorna Osborn

Date Published

30th August 2019

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