Regulatory Index News w/c 28 October 2019

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


FDA blames market failures for drug shortages

An inter-agency U.S. task force looking into drug shortages found "a broken marketplace" and issued a set of recommendations that includes creating a rating system for manufacturers.

To read more follow this BioPharmaDive link


‘Incubator’ launched to support nurses to become research leaders

A new initiative, dubbed the “Nursing and Midwifery Incubator”, has been launched by the National Institute for Health Research (NIHR) in order to accelerate and support the development of nurses and midwives looking to develop a career leading research.

To read more follow this PharmaTimes link


Social media used to boost cancer screening rates

NHS England has detailed its new social media plan, teaching nurses across the country how using online platforms can improve health, as part of one of NHS Digital’s Widening Digital Participation projects.

To read more follow this PharmaTimes link


Novartis gene therapy ambitions dealt another blow by FDA hold on Zolgensma

The Food and Drug Administration partially suspended a trial of Zolgensma in older children with spinal muscular atrophy because of an inflammatory response observed in a small animal study. 

To read more follow this BioPharmaDive link


Roivant, Sumitomo alliance to target cystic fibrosis gene therapy

As part of a $3 billion deal brokered with Roivant Sciences, Japanese drugmaker Sumitomo Dainippon will gain ownership of a newly unveiled biotech focused on developing gene therapies for cystic fibrosis.

To read more follow this BioPharmaDive link


Vumerity nabs FDA approval for MS

The US Food and Drug Administration (FDA) has approved Biogen and Alkermes’ Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis (MS). The oral treatment has been indicated for various forms of the disease.

To read more follow this PharmaTimes link




Lorna Osborn

Date Published

31st October 2019

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