FDA’s Amy Abernethy describes how agency’s use of real-world data has evolved in response to COVID-19 and the ‘a-ha’ moment of leveraging different data sources to understand the coronavirus. Takeda R&D President Andrew Plump notes difficulties with platform trials and limitations on data sharing.

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

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.

October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.

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.

While it was not as affected as some other countries, Japan still had the pandemic to deal with and regulators responded while managing to keep up regular product review work, including several world-first approvals. Coronavirus vaccine roll-outs and the first general annual reimbursement price cut are on the cards for this year. 

Biden Administration’s regulatory freeze suspends HHS action to appoint an administrative dispute resolution board for the 340B program. Good news for manufacturers?

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.

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.