In this week’s news, EMA preps for Brexit, fake drug reports surge in Germany, cell encapsulation set to enter mainstream and more…
EMA reallocates 370 drugs from MHRA to EU-27 member states
The EMA has completed the reallocation of 370 centrally authorised products for which the UK MHRA was previously responsible.
The London-based agency said it transferred the products to new “rapporteurs” last week, explaining they will only take full responsibility for them on 30 March 2019, when the UK withdraws from the European Union.
The EMA did not provide details, but did say the new rapporteurs had been selected based on their scientific knowledge and experience overseeing similar products.
It wrote “Generic medicines, for example, were allocated to national competent authorities who traditionally have participated less in EMA evaluations but have indicated that they would like to increase their involvement with such medicines.”
Fake drugs reports increase in Germany
More counterfeit drugs were reported to German authorities in 2017 than in any previous year according to data released last week.
The study (here in German) revealed that 9,064 fake drug reports were filed with the Drug Commission of German Pharmacists by 4816 different pharmacies last year, an increase of nearly 500 on the previous record.
The organisation – which is known as the AMK – said the increase in reports does not necessarily indicate more fake drug products are circulating.
Instead, it suggested the surge could be due to growing awareness of the counterfeiting problem in Germany.
Cell encapsulation attracting biopharma interest
Eli Lilly’s cell therapy development deal with Sigilon could bring encapsulation into mainstream biotechnology according to experts.
Cell encapsulation involves coating cells with a hydrogel to stop them being rejected and to reduce the need for immunosuppressive drugs. While the science underpinning the approach is well established, high production costs have prevented encapsulation being widely adopted.
The Lilly deal signals a change in attitude according to researchers Brian Salmons and Walter H. Gunzburg writing in BiospectrumAsia.
The argue that, “The next few years will be exciting as additional new encapsulated cell therapies, in particular allogeneic therapies, are developed and opportunities are explored.
“Moreover, the results of clinical trials, including late stage trials should become available, perhaps leading to eventual breakthrough therapies reaching the biotherapeutics market.”
CMO market set to soar according to new research
The global market for contract pharmaceutical manufacturing, research and packaging will be worth $197bn by 2022, up from $136bn last year, according to a new research.
The analysis – by BCC Research – suggests drug companies that outsourced to cut costs in the face of competition, patent loss and Government pricing pressure, will continue to hand work to third parties.
The authors wrote that “The peak of the patent cliff has passed, and research and development productivity is increasing in the industry. Outsourcing that has been transformed from pay for services to partnerships and collaborations is considered the most successful strategy to bring innovation into the drug industry.
They added that strategic partnerships – in which the contractor shares the risks and rewards of innovation – have largely replaced traditional functional outsourcing deals.
Also in the news
Lonza has opened what it claims is the world’s largest cell and gene therapy plant in Pearland in Greater Houston, Texas. Read the full report here.
The US Center for Drug Evaluation and Research’s (CDER) Office of Pharmaceutical Quality has shared details of how it uses science to assess the quality and performance of a drug product. Read more here.