In this week’s news, UK set to fine pharmas that don’t publish trial data, EMA clarifies on cell and gene therapy testing and more…
UK set to fine pharmas that don’t disclose trial results
The UK House of Commons Science and Technology Committee says drug firms that fail to disclose clinical trial results should be punished.
In response to recent calls for sanctions by patient groups, committee chair Norman Lamb MP said, “The Health Research Authority (HRA) must follow my Committee’s recommendation from last autumn to introduce a system of sanctions for those who do not comply with reporting results requirements for clinical trials.
“For too long there has been little consequence to non-compliance with current requirements and it’s time action was taken.”
Lamb said he will encourage the HRA – an executive non-departmental public body of the Department of Health that exists to provide a unified national system for the governance of health research – to propose a system of sanctions.
He added that, “My Committee is committed to ensuring improvements in clinical trials transparency and we will continue to push for change in this area.
“This year we have already written to NHS Trusts in England and universities across the UK reminding them of their responsibilities and put them on notice that if they didn’t get their houses in order, we would be asking them to come before us to explain themselves.”
US FDA prepping to revamp tech to speed decision making
The US FDA plans to revamp its tech infrastructure with the aim of fostering easier data transfer between its various centres and industry.
The US regulator announced the plan last week. Principal Deputy Commissioner Amy Abernethy said the aim is to facilitate better conversation between the agency and industry.
“I want FDA to get our own technical house in order so that tech can ‘snap in’ – we can be agile and efficient.
“We need to be able to have common interfaces with industry so we can pass data between our organizations, have collaborative review, etc,” she said.
EMA explains testing exemptions for cell and gene therapy imports
The EMA has clarified its rules on batch retesting for advanced therapies.
The Amsterdam-based regulator discussed the subject in a Q&A document last week.
The main focus of the document was an explanation of testing exemptions for imported ATMPs – which include gene therapies, cell therapies, tissues for transplant.
It wrote, “The exemption from re-testing batches upon import into the EU for ATMPs may only be granted where the conditions laid down in paragraph 11.17 of the EU GMP guideline for ATMPs are met.”
These conditions are: when there is a limited amount of material available; or when the therapy has a short shelf-life. The guideline also stipulates that initial testing in the third country should be conducted in a GMP-certified facility.
Also in the news
Pfizer has invested $500m in a gene therapy facility in Sanford, North Carolina. According to a press release the plant will create 300 jobs.
RAPS looked at US political concerns that the FDA is not doing enough to prevent potential drug shortages.
The Wall Street Journal reported on changing currents in the US drug pricing debate.
Several top regulators have left the MHRA in recent weeks. In its coverage FierceBiotech linked the departures to the UK’s impending withdrawal from the EU.
Some developments of note in the CDMO space:
iBio will make recombinant human collagen for Lung Biotechnology PBC, a subsidiary of United Therapeutics Corp. The latter firm is developing 3D printed organ transplants.
Thermo Fisher Scientific has opened a virtual reality training centre in Greenville, North Carolina.
Halix has completed construction of a viral vector and protein production facility at the Leiden Bio Science Park in the Netherlands. Read more at Bioprocess Insider.
CMAB Biopharma will make a cancer targeting monoclonal antibody-based drug candidate under a deal with developer Kintor Pharmaceuticals.