Regulatory Index News: 15/08/2018

Welcome to your Regulatory Index News digest. Today we cover a proposed earlier bowel cancer test in England and Wales, a company acquisition in the vaccines arena and a US drug approval in the rare genetic disease Fabry.

FIT test for Bowel Cancer to be offered to all aged 50 in England and Wales

The Government has confirmed that bowel cancer screening in England and Wales is to start a decade earlier in an attempt to earlier identify more cases of the disease.  An independent expert screening committee recommended starting the screening 10 years earlier at 50 years of age using the incoming faecal immunochemical home test kit (FIT). Evidence shows this approach would pick up more bowel cancers at an earlier stage, helping to improve chances of treatment success. The health secretary, Matt Hancock, and public health minister, Steve Brine agreed the recommendations, which NHS England and Public Health England will look to implement as part of the NHS Long Term Plan. Please click here to read more on this from a PharmaTimes article.


Emergent BioSolutions to Acquire Vaccines Company PaxVax for $270M

Emergent BioSolutions has acquired the Cerberus Capital Management majority owned vaccine company PaxVax for a cash deal of $270 million. PaxVax specializes in infectious diseases and provides Emergent with two marketed vaccines to add to their existing portfolio, which includes 3 vaccines in the pipeline targeting anthrax, Zika virus and influenza. PaxVax's Vivotif (typhoid vaccine live oral Ty21a) is the only oral vaccine licensed by the FDA for the prevention of typhoid fever, whereas Vaxchora (cholera vaccine live oral) is the only FDA-licensed vaccine for the prevention of cholera. Please click here to read more on this from a BioPharmaDive article.


US approval for Amicus Therapeutics' Fabry disease drug

Amicus Therapeutics announced on 10 August that it was granted an accelerated US approval for its Fabry disease drug Galafold (migalastat). This treatment gives patients with the rare genetic disorder a new treatment option for the first time in over ten years. Fabry disease is one of 50 or more lysosomal disorders caused by a defect in a gene known as GLA. It causes a buildup of a type of fat in blood vessels and other organs, which can eventually lead to kidney disease, stroke, abnormal heart rhythms and early death. Galafold is an oral drug designed to help boost the activity of an enzyme rendered dysfunctional in Fabry patients, which differs to Sanofi's Fabrazyme (agalsidase beta) that reduces fat deposits in the kidneys. Amicus will conduct a Phase 4 confirmatory study to further characterize Galafold's efficacy and safety as a condition of its accelerated approval. Please click here to read more on this from a BioPharmaDive article.



Lorna Osborn

Date Published

15th August 2018

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