COVID-19 And Its Implications

A move to cut senior FDA positions including CDER Director through the appropriations process is rare and almost certain to fail, but experts say the attempt is indicative of an environment that seems to be encouraging these personal amendments.

EU marketing authorization applications have been submitted for a number of new drugs, including Eli Lilly’s donanemab, Italfarmaco's givinostat and Arcturus Therapeutics/CSL’s ARCT-154.

The World Health Organization has published a “step-by-step guide” for countries wishing to increase their capacity for monitoring pathogens with pandemic and epidemic potential. The EU and the UK have cleared an updated version of Moderna’s COVID-19 vaccine Spikevax targeting the XBB.1.5 variant, while the EU has followed the US in approving Gilead’s Veklury as the first treatment for COVID-19 patients with mild-to-severe liver damage.

The head of the European Medicines Agency says a group of international regulators got together to ensure “global alignment” on the approach to be taken on COVID-19 vaccination. 

Pink Sheet reporter and editors discuss the somewhat novel pricing language in Regeneron’s deal with the US government to develop a COVID-19 monoclonal antibody, US FDA Commissioner Robert Califf hiring a new senior advisor, and optimizing dosing in cancer combination therapies.

As FDA clears new COVID vaccines, the Regeneron deal is a reminder of the politics of drug pricing. Sen. Sanders touts the agreement, which attaches product price caps to funding for clinical development, and he allows the confirmation effort for the NIH director nominee to proceed.

Companies and organizations that signed the contracts deny any heavy-handedness, with Johnson & Johnson saying it worked closely with South Africa on vaccine supply, and the vaccine alliance Gavi noting that the COVAX Facility provided the country with more than nine million doses free of charge.

The Swiss medicines regulator is reviewing an application for Novavax’s vaccine against the XBB.1.5 variant, while ACM Biolabs has announced positive results from a Phase I trial of its COVID-19 booster vaccine, ACM-001.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

The World Health Organization’s C-TAP has signed new COVID-19 vaccine licensing deals with Medigen Vaccine Biologics of Taiwan and a Spanish research body, while the WHO and UNICEF say overall immunization rates are rebounding after the pandemic backslide, but not in all countries equally.

From rapidly identifying antigenic targets to automating clinical trials, AI has an important role to play in cutting vaccine development time down to 100 days, says Melanie Saville, executive director of R&D at CEPI.

The High Court’s decision could have consequences for the negotiation of vaccine contracts in other countries and might also lead to a strengthening of the provisions on transparency and accountability in talks on a future pandemic treaty, says the Health Justice Initiative.

An assessment of the European Medicines Agency’s performance in tackling the COVID-19 pandemic shows that the agency was “well prepared” with a crisis management plan but that it faced a range of challenges such as the fallout from Brexit, a heavy workload and how to maintain the public’s trust in medicines regulation.

The European Medicines Agency said Noël Wathion, who retired two years ago, will be remembered for steering the agency through challenges such as Brexit and COVID-19, in addition to being a champion of transparency and public engagement.

The UK is extending flexibilities that were introduced to ensure the supply and availability of COVID-19 and flu vaccines and has published its autumn vaccination schedule. Novavax expects to have its vaccine against the XBB strain of the virus ready by the end of September, while UK firm Infex is planning to begin clinical trials with a rival to Pfizer’s Paxlovid.

A new UK center is to work with the pharmaceutical industry and international regulators on the development and evaluation of vaccines against future pandemic agents, and has a potential vaccine against Crimean-Congo hemorrhagic fever in Phase I trials. The center is expected to play a key role in helping the global “100 Days Mission” achieve its aim of accelerating the availability of new medical countermeasures in future health crises.