In this week’s news, more Brexit concerns, US FDA backs innovation, regenerative meds surged in 2018 says report, and more…

NHS’ access to meds “in the balance” under any Brexit scenario says study

Brexit will damage the National Health Service according to researchers who say access to medicines and devices “hangs in the balance.”

The warning comes from research in the Lancet, in which the authors found that pulling out of the EU – irrespective of whether via a soft Brexit, hard Brexit or no-deal Brexit – will have a detrimental impact on public provision of healthcare in the UK.

No-deal – the option whereby the UK would leave the bloc without trade agreements in place – would cause the most damage the researchers say, citing drug importation as a major concern.

“With a No-Deal Brexit scenario, the UK will be free to establish its own trade agreements with non-EU countries, but such negotiations are in early stages, and there is no foreseeable plan for provisions to bridge any temporary gap.”

The Government’s proposed withdrawal agreement does provide some clarity on drug imports up to 2020. However, as the authors point out, the deal has not been approved by parliament and looks unlikely to win support.

More Brexit concerns: Pharmacists worried about shortages

Publication of the Lancet article coincided with both the EMA’s departure from London and the Royal Pharmaceutical Society launch of a website advising members of its “serious shortage protocol.”

Similar concerns about the damage Brexit will cause to the healthcare sector were shared by Graham Phillips, superintendent pharmacist of the Manor Group Pharmacies.

He told the Pharmacist I’m against Brexit because the world is getting bigger and pharmaceutical companies are getting bigger. The idea that we can take all this on as a standalone nation is risible.”

US FDA reaffirms support for drug manufacturing innovation

The US FDA reiterated support for innovation in drug production last week, with draft guidance for ‘continuous manufacturing.’

Continuous manufacturing, as the name suggests, refers to production operations that run without stopping. Traditionally, drugs have been made in batches, where production lines operate for a specified length of time.

However, pharmaceutical firms should consider switch according to FDA Commissioner Scott Gottlieb, who outlined the potential advantages offered by continuous manufacturing in a statement last week.

“CM helps to ensure consistently-made products, allows manufacturers to more easily scale their manufacturing operations to meet demand, and can help reduce drug shortages by minimizing operational stops and starts,” he said, adding “CM systems also require smaller footprints to operate.”

The comment coincides with the publication of draft guidelines to help drug companies ensure products made using the continuous approach are of the required quality. The document covers key considerations as well as control and validation strategies.

Regenerative meds surge in 2018 says industry group

European approval for several CAR-T therapies was just one highlight of 2018 according to Alliance for Regenerative Medicine, which published its report on the global industry last week.

The group also cited the EMA’s approval of Spark’s Luxturna, the US FDA’s clearance of Avita Medical’s Recell as well as the Japanese MHLW’s conditional backing for cell therapies for Alzheimer’s disease and spinal cord injuries as other examples.

The regenerative meds sector also attracted significant financing. According to the ARM, $13 billion in investment was garnered by developers, some of which was used to pay for the 1,028 clinical trials carried out last year.

Also in the news

The CAR-T therapy sector will continue to expand although commercialising such therapies is still a challenge according to research published in Science.

The US FDA is working to ensure the quality of generic drugs made outside the country according to a statement by Commissioner Gottlieb last week.

MIT Technology Review looked at efforts to develop a gene therapy for Alzheimer’s disease.

UK Government plans to encourage clinical trial transparency are not being supported by appropriate funding according to a report in STAT.

CNN reported on the impact of parents opting not to get their children vaccinated against serious, life threatening diseases.