This week in pharma…25th March

25th March, 2021

In this week’s news, EC wants to tweak vaccine rules for COVID-19 variants, FDA and industry talk manufacturing fees and more…

EC wants to tweak rules for COVID-19 variant vaccines

The European Commission wants to tweak rules to allow the EMA to more quickly authorize COVID-19 vaccines that have been adapted to address variants of the SARS-CoV-2 virus.

The proposed rule changes – which still need to be approved by the European Parliament and Council – are modelled on the regulations used to speed the approval of seasonal influenza vaccines.

According to commissioner for Health and Food Safety, Stella Kyriakides said: “We need to be prepared to adapt vaccines as quickly as possible to respond to new and potentially vaccine-resistant variants.”

Of note for manufacturers and CDMOs is the Commission’s statement that, “Adaptations to active substances of an authorised COVID-19 vaccine may be required to ensure the vaccine’s effectiveness against mutations or variants of a virus.”

Industry and FDA conclude latest PDUFA VII talks

Industry and the US FDA concluded the sixth round of PDUFA VII talks this week with a series of subgroup meetings focused on edits and updates to draft commitment language.

The Prescription Drug User Fee Amendments reauthorization (PDFUA VII) Act will set the rules for how allowed the Food and Drug Administration can collect fees from drug manufacturers to fund the new drug approval process. The legislation – which will cover fiscal years 2023-2027 – has been discussed at several meetings over the past few months.

Manufacturing was a topic of discussion at the most recent meeting according to minutes published this week. Industry and the agency agreed that the PDUFA VII section covering manufacturing needs to be “general” to maintain flexibility in discussions in future.

In addition, after reviewing the draft line by line –agency and industry representatives agreed minor updates to the “commitment language regarding product quality information requests to provide more context on the four-part harmony principles.”

Facility inspections were also covered. Industry and FDA agreed on language designed to enhance two-way inspection communication for applications, not including supplements.

“Both parties also discussed eligibility requirements for the Chemistry, Manufacturing, and Controls Readiness Pilot program and what information would be publicly disclosed related to applications accepted into the Pilot.

FDA launches biocompatibility device resource

The US FDA has introduced a resource to allow medical device makers and CDMOs to test the biocompatibility of their products.

The resource is intended to explain terms and concepts for use in conjunction with guidance adopted by the FDA last year.

Also in the news

Pharmaceutical Technology examined Western China’s pharmaceutical production sector. The region offers great potential as Chinese and foreign pharmaceutical demand continues to grow according to the authors.

The New York Times looked at EU plans to temporarily restrict COVID-19 vaccine exports.

Industry has urged the US FDA to tweak its pharmaceutical quality metrics requirements according to the PinkSheet. (Subscription).

An industry consortium has been formed to promote manufacturing and tracking standards for cell therapies for the treatment of cancer. Read more at Precision Oncology News.

Pharma Exec discussed the impact US President Joe Biden’s “American Recovery Plan” will have on the drug manufacturing industry.

Packaging News reported that GSK Consumer Healthcare has linked up with Pulpex to explore the use of paper bottles into its packaging.

CDMO tends

Some developments of note in the contracting sector:

Monoclonal antibody contractor mAbxience has announced plans to increase production capacity at its facility in León, Spain. The CDMO said it will install a 4,000 L bioreactor at the site. Read more at Bioprocess Insider.

Catalent says it will expand its plant in Anagni, Italy to support production of J&J’s single-shot COVID-19 vaccine. See press release.

WuXi Biologics will buy a 90% interest in CMAB Biopharma Group, a CDMO that provides cell -line development, process development to clinical GMP manufacturing services.

Rentschler Biopharma and Leukocare AG has expanded their alliance with the opening of a Leukocare development lab and offices at Rentschler’s facility in the Greater Boston area. See more at Contract pharma.