In this week’s news, FDA has eve of Covid-19 variants, EU tweaks trial data regs and more…

US FDA preparing to tweak guidelines in light of Covid-19 variants

The US FDA plans new guidelines for drug firms and CDMOs making Covid-19 vaccines and therapeutics that take SARS-CoV-2 variants into account.

According to acting commissioner Janet Woodcock, the agency has been monitoring the spread of new virus strains – including those from England, South Africa and Brazil – and plans to update its product development guidelines.

“We must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic” she wrote, citing the FDA expertise working with annual influenza variants as an example of its ability to adapt.

Specifics were not provided, however, Woodcock said the agency is working on ways to expedite therapeutics – particularly mAbs – and is looking at how manufacturers can generate pre-clinical, clinical and chemistry, manufacturing and controls data.

CBER hit biologics review targets amid 2020 disruption

The FDA team that handles biopharmaceutical products hit its review targets despite disruption caused by the pandemic.

The Center for Biologics Evaluation and Research’s annual report indicates the agency achieved milestones for both product safety assessment and biostatistics work, including for vaccine and therapeutics for SARS-CoV-2.

CBER director Peter Marks said the agency took important steps forward in non-pandemic areas, amid the transition to working from home and all-virtual meeting formats.

He cited the five novel biologics licensed by the CBER during the period – which include Palforzia for peanut allergy and the lymphoma therapy Tecartus – as highlights of the agency’s work.

US FDA nods for several innovative medical devices

In other news, the FDA has granted breakthrough device designation to several cardiovascular disease products, including a heart pump developed by Puzzle Medical Devices.

The nod follows days after the agency granted Alleviant Medical Receives Breakthrough Designation for its Transcatheter Technology. It also cleared a cardiac transport device developed by Vascular Perfusion Solutions.

EU okays remote trial data verification during Covid-19 pandemic

The EU plans to expand use of remote source trial data verification during the pandemic.

In updated guidance published last week the EU expanded the types of trials that can use remote source data verification (rSDV) – the process of cross-referencing data recorded in a case-report form to the original source information online through a secure portal – and other monitoring methods during the COVID-19 pandemic.

The guidance states, “Taking into account the continuing nature of the COVID-19 pandemic and the need to ensure the quality of clinical trial data and to protect the rights, safety and well-being of the participants in the EU/EEA [European Economic Area], remote source data verification (rSDV) can be justified in clinical trials.”

Also in the news

The US FDA has authorized the emergency use of bamlanivimab and etesevimab, Eli Lilly’s combination monoclonal antibody therapy for the treatment of Covid-19. Read statement here.

STAT says the generic drug sector will welcome the US federal appeals courts decision to throw out controversial ‘skinny labelling’ rules.

The Pink Sheet covered the latest round of GDUFA III negotiations. According to the report the FDA is not ready to make additional changes to approval process, even though industry says guidance practices and communications need fixing.

French API contract manufacturer Segens is for sale according to a report by Fierce Pharma.

A Reuters article suggested majority owner Eurazeo has tasked JPMorgan with finding a buyer for Segens, which is valued at more than $2.4 billion.

CDMO tends

Some developments of note in the contracting sector:

The US Department of Defense has hired Just-Evotec Biologics to make monoclonal antibodies for the development of anti-SARS-CoV-2. Read more at Bioprocess Insider.

Active Biotech AB has reached a manufacturing agreement with Famar Health Care Services Madrid SAU. See Contract Pharma.

Quotient Sciences has acquired UK CDMO Arcinova. See press release.

Lonza has agreed to sell its specialty ingredients business to private equity group Bain Capital and Cinven. See press release.