In this week’s news, UK cell and gene therapy hub open for business, EMA proposes changes to vaccine trial rules, generics group backs SPC revisions and more…
UK cell and gene therapy facility open for business
The UK Government funded organisation Cell and Gene Therapy Catapult has opened its £60m manufacturing facility in Stevenage.
The facility is designed to provide developers of clinical-trial-ready cell and gene therapies with access to GMP manufacturing capacity, the latest technology and production expertise.
CGTC CEO Keith Thompson said, “The centre is a major statement of intent and a springboard for industry in its global development. The launch of this important facility pushes the agenda forward and accelerates the timeframe for bringing these living medicines to patients.”
Development of the centre by CGTC has been supported by Autolus, Cell Medica, AdaptImmune, Freeline and Thermo Fisher Scientific.
EMA has proposed revisions to its guidelines for vaccine trials
The EMA has announced plans to update its rules for vaccine clinical trials and called for industry feedback.
The guidelines would introduce safeguards designed to ensure vaccines are assessed in line with the most up-to-date science. The EMA has also suggested assessing the vaccines in certain populations, including pregnant women and the elderly.
The proposed guidelines also set out how developers should employ priming and boosting strategies – which are used to enhance vaccine efficacy – in their studies.
Interested parties are asked to provide feedback by the end of October.
Generics sector backing for SPC export manufacturing waiver
A generics industry group says letting manufacturers make export drugs in Europe while a Supplementary Protection Certificate (SPC) is in place will create jobs and foster growth.
In the EEA, a supplementary protection certificate (SPC) is used to extend the patent life of a branded drug product to compensate for any delays during the approval process.
Currently, generic manufacturers are not allowed to manufacture or sell non-branded versions of the product in question in the EEA or elsewhere while the SPC in force.
However, in October the European Commission said it is thinking about revising the rules to allow generics firms to make products for export in Europe while an SPC is in place.
Medicines for Europe spoke about the idea in London last week.
Legal affairs director Sergio Napolitano said, “An efficient, pro-competitive legal environment that includes the SPC manufacturing waiver will boost investments in our sector, facilitate faster access to medicines for patients, contribute to the sustainability of healthcare systems across Europe and we stand ready to support these positive measures”.
Changes to the SPC are, understandably, less popular with the branded drug industry. In a recent report, EFPIA argued that allowing manufacturing would hamper innovation.
Warning letter and Brexit prompt higher generic prices
Greater regulatory scrutiny of manufacturers in key supply hubs combined with Brexit-related uncertainties are pushing up generic drug prices according to a UK pharmacy group.
Mark Burdon from the Pharmaceutical Services Negotiating Committee (PSNC) told RPS the generics market “went berserk” in 2017, explaining that UK national pricing authorities have been overwhelmed.
The comments come days after the publication of a report suggesting the NHS budget is not keeping pace with increased spending on medicines.
Also in the news
The UK MHRA has banned the epilepsy drug sodium valproate over concerns it causes birth defects. Read the full Pharmafile report.
Sterling Pharma Solutions has predicted that continuous manufacturing will reshape the API production industry. Read more at Manufacturing Chemist.
European patients will continue to have greater access to biosimilars than people in the US and Canada according to experts at a conference in London. Read the RAPS report.