Regulatory Index News w/c 21 January 2019

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


MHRA grants approval for RXC004 trial restart

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has given formal approval for Redx to re-commence a Phase I/IIa trial of experimental cancer therapy RXC004.

To read more follow this PharmaTimes link 


Advaxis hit with clinical hold for cervical cancer drug

The Food and Drug Administration has placed a partial clinical hold on a Phase 3 study run by New Jersey biotech Advaxis, seeking additional clarifying details on chemistry, manufacturing and controls, or CMC. 

To read more follow this BioPharmaDive link


Lilly's Lartruvo shouldn't be given to new patients, EMA says

The European Medicines Agency said doctors shouldn't prescribe Eli Lilly's Lartruvo cancer drug to any new patients after a Phase 3 study of the drug showed no survival benefit.

To read more follow this BioPharmaDive link


15-year-old brain cancer patient to receive specialist radiotherapy

A 15-year-old boy with a rare brain tumour is set to begin innovative world-leading treatment at the NHS’s new Proton Beam Therapy centre, at The Christie hospital in Manchester.

To read more follow this PharmaTimes link


Ozempic launched for type II diabetes in the UK

Novo Nordisk has announced that Ozempic, a new once-weekly GLP-1 (human glucagon-like peptide-1) analogue injection for the treatment of type II diabetes, is now available in the UK.

To read more follow this PharmaTimes link


Opdivo questions hang over Bristol-Myers amid sales miss

Bristol-Myers Squibb, in selling its $74 billion buyout of Celgene to Wall Street, has touted the broad pipeline and near-term commercial opportunities it would gain through a deal. Yet the attention of investors and analysts remains laser focused on the future for what would be the combined company's top-selling drugs, Opdivo and Revlimid.

To read more follow this BioPharmaDive link




Lorna Osborn

Date Published

24th January 2019

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