UnaCom Pharmaceutical news 

                                                 6th August--12 August 

Collaboration between Immune Biosolutions and Janssen

Immune Biosolutions and Janssen, have announced a research collaboration. The research will explore the development of therapeutic antibodies in oncology. The partnership will use Immune Biosciences' Nebula antibody discovery platform to advance oncology targets that historically have been a challenge for therapeutic development. (Pharmatimes.com 2018)
The Nebula platform utilizes four families of technologies in a single platform to deliver antibody therapies.

MHRA announces Post Brexit Plans

Big news this week, is that MHRA, the British Regulations System, has announced how UK clinical trials rules will operate in a post Brexit Britain. As well as a document being released providing technical guidance on Brexit implementation, the MHRA has stated that during the Brexit transition period ( 30th March 2019–31 December 2020), EU rules and regulations will remain in place to provide continuity and certainty to businesses. The EUs new Clinical Trials Regulation (CTR) which is expected to be implemented in 2020, will apply to the UK in this time period. This new regulation is a ‘major step forward’ said the Agency. With it providing a streamlined application process, harmonized assessment procedures, a single portal for all EU clinical trials and simplified reporting procedures. If CTR is not implemented during the transition period, UK law will be aligned to with parts of the CTR that the UK government has control over.Thus giving researchers operating clinical trials greater certainty. What the UK would have no control over, is the single shared IT portal and participation in the single assessment model. These two elements would require a EU/UK agreement. The negotiations cannot be predicted, but the UK has made it very clear for close association and partnership with the EU.

New GSK Chief Financial Officer 

GSK appoints new Chief Financial Officer (CFO) Ian Mackay. Set to take over from Simon Dingermans, who is to retire in May 2019. This is one of many new additions made be recently appointed CEO, Emma Walmsley. Who has appointed Luke Miles as head of pharmaceuticals,Hal Barron as drug research and Karenann Terrell as head of digital operations. Ian Mackey comes with great financial experience, who was previously Group Finance Director for HSBC for the last 8 years.

Success for Pfizer Appeal 

NICE has reversed its decision of rejecting Pfizer’s Besponsa. A treatment for adults with a certain form of leukemia. An appeal was made by Pfizer against the decision to reject Besponsa, back in June last year.  The argument for NICE was that the clinical trials showed no survival benefit using Besponsa compared to the current treatment used. But it did note that those that were treated with the drug were able to have stem cell transplant and go into remission than those on standard care.

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