The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.

Hungary is going its own way when it comes to coronavirus vaccines, but its decision to allow the emergency use of the Oxford University/AstraZeneca vaccine may be only a symbolic expression of the government’s growing impatience with the EU.

To help with the transition to Biden’s COVID-19 response, Woodcock will retain some therapeutic development duties in the program the Trump administration had called Operation Warp Speed.

The UK government says it will begin a consultation on a future falsified medicines scheme for Great Britain within a year after the passage of new legislation on medicines and medical devices. Moves are also under way to ensure the smooth supply of medicines from GB to Cyprus, Ireland, Malta and Northern Ireland.

Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.

User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.

If Biden administration wants to nominate the acting commissioner, Vacancies Reform Act would dictate the timing. Woodcock can still get the nod and remain head of the agency during the confirmation process, just as Andrew von Eschenbach retained his acting title following his nomination in 2006.

If not reversed by the Biden Administration, demo program that puts plans at increased risk in catastrophic phase would also enhance negotiating leverage for drugs in the protected classes.

Use of preferred and non-preferred specialty formulary tiers will be allowed but preferred tiers are not necessarily limited to generics and biosimilars and coinsurance for non-preferred specialty drugs cannot exceed 33%.

Broader use of adaptive trial designs and master protocols, checklist-based application review, and enhancement of real-world monitoring of products are among the recommendations of US FDA's COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) report, an effort months in making based on interviews with agency management, staff, and outside stakeholders.

Daily round-up from the virtual J.P. Morgan Healthcare Conference: Viatris debuts; Chi-Med charts its own path; Novo takes another go at obesity; Sangamo moves forward with CAR-Treg; Intercept readies for resubmission; and ImmunoGen is relying on a safety advantage for its ADC. 

Daily round-up from the virtual J.P. Morgan Healthcare Conference: Teva promises growth is coming; Relay joins Roche in the KRAS race; UCB embraces the digital age; Agios and Ionis prepare for commercial battles. 

Proposal, which could be formally endorsed by MedPac this spring, would lower the payment rates for vaccines while simultaneously moving all preventative vaccine coverage to Medicare Part B. Commission signals further cuts to payment rate, through an average sales priced-based methodology that might eventually be recommended.

US hopes more publicity will boost use of Lilly and Regeneron COVID-19 antibodies, once anticipated to be in short supply, but federal officials lack any other clear strategy to help overwhelmed health systems. Meanwhile Operation Warp Speed is testing the treatments against new virus variants and working on developing antibody cocktails that could avoid escape mutants as FDA issues guidance on potency assays for sponsors.

Daily round-up from the virtual J.P. Morgan Healthcare Conference: Viatris debuts; Chi-Med charts its own path; Novo takes another go at obesity; Sangamo moves forward with CAR-Treg; Intercept readies for resubmission; and ImmunoGen is relying on a safety advantage for its ADC. 

The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.

Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.

The US FDA managed to issue 94 drug GMP warning letters last year despite the pandemic, with fewer expected for 2021. Top issue areas included lack of sterility assurance, nitrosamine impurities, poor data integrity and basic GMP failures.