In this week’s news, the US FDA issues guidelines to help pharma resume production under GMP, the EMA encourages firms to publish all Covid-19 clinical data and more…

EU plans biomedical agency to prep for pandemics

The European Union will set up a biomedical research agency and hold a summit in Italy to engage the industry to prepare for future pandemics.

European Commission President Ursula von der Leyen announced the plan last week according to Reuters. She also said she would reinforce the European Medicines Agency and the European Centre for Disease Prevention and Control.

US FDA issues guidance to help drug firms resume production

The US FDA has issued guidance to help biologics manufactures resume production.

The US regulator said the aim is to help firms with “current good manufacturing practice (CGMP) activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply.”

Under the guidelines, firms whose activities deviated from CGMP during the pandemic to date should include an assessment of those actions. The agency also said companies resuming production should prioritize meds that are in short supply.

The FDA also makes clear that any product batches where production was interrupted should remain in quarantine until remediation activities that assure drug quality can be completed.

US FDA med device warning letters down again

The US FDA issued only a small number of warning letters to medical device manufactures in the first half of 2020 than in previous years, according to analysis by the ECA.

The ECA issued its report last week, revealing that the US regulator issued 15 warning letters to device firms in the six months to the end of June.

The EDA suggests the small number of warnings reflected both improvements in the device sector and the FDA’s efforts to engage with manufacturers earlier in the process.

“The FDA responds directly and interacts with companies in response to the letter that the inspected company sends to the FDA in response to a 483-deficiency report. In return, it issues fewer Warning Letters. It will be interesting to see if this trend continues in the second half of the year, as it has in the last three years.”

Also in the news

STAT took a look at the impact of Operation Warp Speed, the US Government’s effort to accelerate development of SARS-CoV-2 vaccines and Covid-19 therapies.

US FDA commissioner Stephen Hahn suggested in an op-ed that the coronavirus pandemic underlines the need for the US to make more drugs.

The EMA will require companies developing Covid-19 treatments to publish all clinical trial data.

The WHO urged governments to ensure access to SARS-CoV-2 vaccines and Covid-19 therapies and prepare for future pandemics in message to the UN general assembly.

Medtech Insight reported growing calls for the EU to rethink deadlines for compliance with new regulations covering in vitro diagnostics. See more here (subscription required).

RAPS reported FDA calls for stakeholders to contribute to upcoming GDUFA talks.

CDMO tends

Some developments of note in the contracting sector:

Catalent will spend $130 million to set up a third gene therapy manufacturing facility at its campus in Harmans, Maryland.

Thermo Fisher Scientific has joined the list of CDMOs that will make INOVIO’s DNA COVID-19 vaccine candidate INO-4800.

Virtual manufacturing site audits should be the new normal according to Jeannie Metzinger, Chief Compliance and Quality Officer at PCI Pharma Services.

Single-use technology firm ILC Dover has bought Solo Containment, a specialist manufacturer of flexible film isolators.

Merck Millipore has announced a €59 million expansion of its HPAPI and ADC manufacturing capacity at its facility near Madison, Wisconsin.