In this week’s news, US FDA cancels most overseas plant audits in April, EMA waives advice fees for covid-19 vaccine developers and more…
US FDA cancels all overseas facility inspections over Covid-19 concerns
The US FDA has cancelled ‘most’ overseas drug and API manufacturing facility inspections planned for April citing the covid-19 pandemic.
The regulator took the decision last week. It said will only visit sites deemed to be “mission critical” on a case by case basis and acknowledged the move will impact drug reviews.
“We are aware of how this action may impact other FDA responsibilities, including product application reviews. We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.”
Instead of inspections the FDA said it will employ additional tools to ensure the safety of products imported, citing examinations and sampling at borders and assessments of suppliers’ compliance histories as examples.
The agency also plans to make use of facility inspection information held by regulators overseas under existing mutual recognition deals.
EMA waves fees for Covid-19 vaccine and treatment developers
The EMA will provide scientific advice to firms working on covid-19 vaccines and treatments free of charge.
The Amsterdam-based regulator last Friday, explaining that it aims to encourage and accelerate development.
“In the context of the COVID-19 pandemic, with this fast-track scientific advice, the Agency can give developers prompt guidance and direction on the best methods and study designs to generate robust information on how well a medicine or vaccine works and how safe it is.”
Normally the EMA charges between €43,700 and €87,600 for its scientific advice.
The EMA also said, “Timelines for vaccine development are difficult to predict at this point, but it is currently estimated that the first clinical trials will not start before April/May 2020.
“Once there is sufficient information available, EMA is ready to assess any applications for marketing authorisation within the shortest possible timelines.”
Also in the news
The US Government’s response to the covid-19 includes measures to ensure federal agencies “buy American.”
The New York Times reports that the pandemic has reawakened Trump Government efforts to reduce the country’s dependence on China made medicines.
More than 400 cell and gene therapies are in development according to a report by US industry group PhRMA.
Some developments of note in the contract services space:
GT Biopharma has hired Cytovance to provide development services for a therapeutic for the treatment of coronavirus infection. The treatment is based on the formers NK cell engager platform. See press release.
Bora Pharmaceuticals will acquire GSK’s facility in Mississauga, Ontario. Bora will make several medicines at the plant under contract. See press release.
Emergent will make Novavax’s covid-19 vaccine for Phase I clinical trials. See full report.
Fujifilm Diosynth has started work on its biocampus development in Billingham in the UK. See press release.