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Gene therapy gives
hope to patients
with ‘butterfly skin’

2023-05-25T11:03:00+01:00By Catrin Jackson

FDA approves first gene therapy to treat dystrophic epidermolysis bullosa patients – a condition sometimes called ‘butterfly skin’.


HIV-prevention drug is first to be made in South Africa

2023-05-25T10:33:00+01:00By Catrin Jackson and Alan Booth

Indian firm Cipla is first manufacturer approved to produce generic of the
HIV-preventer cabotegravir, in South Africa.


Novel gene editing method “roughly threefold” better

2023-05-19T15:54:00+01:00By Catrin Jackson

Researchers from the University of California Santa Barbara (UCSB) have found two ways to boost the capabilities of CRISPR/Cas9.

Leslie Dowling

Changing of the guard at Regulatory Rapporteur


Leslie DowlingEditor-in-Chief of the Regulatory Rapporteur, for 12 years steps down:
Davina Stevenson set to take on lead of respected journal.


FDA licence for first drug to treat agitation in Alzheimer’s

2023-05-12T12:36:00+01:00By Catrin Jackson

Rexulti has become the first FDA-approved treatment for agitation associated with dementia due to Alzheimer’s disease.

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First anaemia drug for cats given
‘expanded conditional approval’

2023-05-12T08:25:00+01:00By Catrin Jackson

Varenzin-CA1 is the first drug approved for cats with nonregenerative 
anaemia, under the FDA’s expanded conditional approval pathway.



UK set to accept CE mark for medical devices until 2028


The MHRA has confirmed an extension to certain CE-marked medical devices being placed on the GB market until June 2028

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Northern Ireland deal permits GB medicines but not medical devices


On 27 February 2023, the Government of the United Kingdom (UK) and the EU Commission announced a political agreement in principle on the Windsor Framework.



Regulating Vaxzevria:
The world’s first COVID-19 vaccine

Vol. 20 #4
Hosted by Alan Booth, managing editor of Regulatory Rapporteur, this episode of RegRapPod  is an extended conversation with authors Priti Shah and Anna Litsiou following on from their article in the April issue [Vol. 20 #4]Priti and Anna share insights around the regulatory process of AstraZeneca’s COVID-19 vaccine - Vaxzevria.

RR-Pod-April-23-1920x1080-brand-colours - PODCAST ARTWORK


April 2023

Vol. 20 #4
Our new RegRapPod – the first episode of our podcast series – is available to listen to now. April’s Issue Editor, Vickie Goff discusses Latin America articles with podcast host Alan Booth, who also hears from authors Priti Shah and Anna Litsiou whose article this month is covered in a full interview in a later edition.