Unacom Pharma News

Monday 11th February 2019

Industry fear about Brexit withdrawal legislation

The Patents Regulation 2018 Statutory Instrument covers the UKs exit from the EU patent regime but according to the bio-pharma industry it could weaken the UKs IP infrastructure and thus affect our reputation as a leader in the life sciences.

The primary concern was with how the Statutory Instrument would affect the SPC (Supplementary Patent Certificates), which provide up to an extra five years of additional patent life to make up for the years taken for regulatory approval. Concerns are raised because of how the UK government will calculate the SPC with it likely to be based on only a UK market authorization, rather than the first approval granted by a European Economic Area (EEA) country. This would lead to industry launching new products later in the UK compared to the EU and also the SPC period could be shorter for UK compared to the EU, thus reducing the attractiveness of the UK as bio-sciences hub.

Tuesday 12th February 2019

Cancer drugs and China help AstraZeneca’s climb to growth

AZ continues its recovery to growth after suffering patent losses with its promising cancer drugs leading the way. Sales rose 5% to $5.77bn in the fourth quarter, following an upward trend that started in the third quarter and put AZ in positive territory for the full-year for the first time in almost a decade. The return to annual growth, resulted in a 4.7% rise in AZ’s shares, as a 50% increase in sales for the company’s cancer franchise was released. With new launches of Lynparza and Tagrisso both doubling in the year – and a 28% increase in Chinese revenues. The star in its portfolio was Tagrisso, which grew 95% to $1.86bn last year.

This reflects strongly on AZ reorganization of its R&D department, to focus on growing cancer drugs, by splitting the oncology and bio pharma divisions.

Wednesday 13th February

Novartis is the first to benefit from NICE spin off for advice on patient preference

NICE’s Scientific Advice team has produced its first guidance on how pharma companies can improve clinical trial design, to meet the needs of patients.
The Scientific advice team is a spin off the cost agency NICE and provides a fee-based service to bio-pharma, medical devices and diagnostic companies. It has announced today that it has provided its first piece advice to Novartis on the design of a ‘patient preference’ study - these aim to capture patient insights which can then be incorporated into the clinical development programmes for new treatments.
In its last financial year, this branch generated a £1.8m income, which is a nice contribution to sustaining the agency, which has seen its workload increase and funding cut by the Government.

Nigel Cook, Head of Decision Support and Insights, Global Patient Access at Novartis said: “ The scientific advice provided by NICE, together with the patient representative and other external experts, has been very valuable to Novartis; both in endorsing the approach to gathering early patient preference data to inform evidence generation plans, and in regard to valuable input received to improve the design of the COPD patient preference study.

There have been concerns that NICE’s fee-based approach for technology appraisals could compromise integrity and their decision making. NICE has since clarified that paying for scientific advice has no bearing on tech appraisals and will not make a positive recommendation more likely.

Thursday 14th February.

Europe's first medicine tracking system goes live. 

The new worlds first digital tracking system covering the medicine supply chain across the EU has gone live, promising greater security against counterfeit medicines. The new European Medicines Verification System (EMVS) is a world first and uses a 2D data matrix (barcode) to track every pack of medicines as they make their way from the manufacturer into the supply chain and on to the patient. The medicines also now have anti-tamper device (ATD) to ensure they are not interfered with before the patient receives them. This system aims to prevent the occurrence of fake drugs entering the supply chain, which has quickly become a multi-million pound industry. 

The EMVS will connect around 2,000 pharmaceutical companies, around 6,000 wholesale distribution authorization holders, 140,000 pharmacies, 5,000 hospital pharmacies and around 2,000 dispensing doctors in 28 EEA countries. 

The UK pharma industry and NICE welcomed the new system, praising it as the ‘world’s best’ medicines safety system and that it would be a travesty if the UK had to leave the system because of a no deal Brexit.

Friday 15th February

The potential in AI predicting survival of Ovarian Cancer Patients.

Researchers from Imperial College London have created an AI software that can predict the survival rates and responses to treatments of patients with ovarian cancer. Researchers say that this new tech could help clinicians administer the best/most effective treatment to patients faster and pave the way for more personalized medicines. AI has the huge potential to revolutionize the healthcare industry by offering more accurate and earlier diagnoses, transforming the lives of the patients.

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