With 12 new BTDs announced so far this year, 2021 is on pace to match the COVID-19-depressed total number of designations in 2020. Here’s a breakdown of the candidates that have received the designation.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Pink Sheet reporters and editors discuss the response to the rare blood clots seen with Janssen’s COVID-19 vaccine, the US FDA’s new virtual facility inspection guidance, and the new permanent director of the Center for Drug Evaluation and Research.

‘Treacherous combination’ of small clinical trials, lagging enrollment, unreported results and uncompleted trials is hindering COVID-19 research, former FDA Commissioner Califf says. Yale professor calls for a ‘Manhattan Project’ around knowledge and a change in the academic star system.

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

After preliminary discussions with its pandemic task force, the European Medicines Agency has begun reviewing GSK/Vir Biotechnology’s promising COVID-19 treatment to help EU national competent authorities make evidence-based decisions on its possible early use.

HHS Secretary Becerra answers questions about the scope of the proposed ARPA-H agency; more to come during NIH budget hearing.

Formal MACPAC proposal to US Congress to consider enhanced rebates for drugs approved via the Accelerated Approval pathway could have a long shelf life in the context of debates over drug pricing – and over FDA regulatory reforms.

Trade group’s new agenda offers few original solutions to tackle US drug costs, relying on old standbys and reminders of what medical innovation might be lost if industry is financially targeted by policy makers with a strong nod to drug manufacturers role the current pandemic.

HHS Secretary Becerra answers questions about the scope of the proposed ARPA-H agency; more to come during NIH budget hearing.

‘Treacherous combination’ of small clinical trials, lagging enrollment, unreported results and uncompleted trials is hindering COVID-19 research, former FDA Commissioner Califf says. Yale professor calls for a ‘Manhattan Project’ around knowledge and a change in the academic star system.

US FDA plans to release a second set of guidances to industry; sponsors caution that tradeoffs need to be clear from onset.

Trade group’s new agenda offers few original solutions to tackle US drug costs, relying on old standbys and reminders of what medical innovation might be lost if industry is financially targeted by policy makers with a strong nod to drug manufacturers role the current pandemic.

China's historic antitrust fine against Alibaba indicates regulatory attention to anticompetitive practices is mounting. While the pharma sector remains segmented, investigators appear to be taking a generally more sophisticated approach to transgressions.

ICER signals how it will pick other therapies for pilot in interview with Pink Sheet. Aetion believes project will help 'pressure test' the RWE field and show health plans and providers the value of using real world evidence to supplement clinical trial data.

Pink Sheet reporters and editors discuss the response to the rare blood clots seen with Janssen’s COVID-19 vaccine, the US FDA’s new virtual facility inspection guidance, and the new permanent director of the Center for Drug Evaluation and Research.

The focus would be on high-impact changes to high-impact models under approach advocated by BioPhorum, IQ Consortium and PPAR.

Acting FDA Commissioner Janet Woodcock says FDA is interested in establishing new ‘Centers of Excellence’ but the current environment is not the right time to make changes at the agency. Woodcock also talked about where FDA will spend its new pandemic money and its reexamination of accelerated approval drugs in a wide-sweeping conversation with the Alliance for a Stronger FDA.