The Biotechnology Innovation Organization (BIO) is urging companies and regulators involved in the development, approval, manufacture and distribution of COVID-19 therapies and vaccines to commit to principles essential to building public trust in those products. BIO outlined those principles in a Sept. 3 open letter, calling on the biopharmaceutical industry to conduct ethical clinical trials in accordance with best practices and to disclose important clinical data via well-respected scientific meetings or rigorous, independent peer-review journals. As for the FDA, BIO said the agency should maintain its historic independence, free from external influence, and it should ensure the appropriate use of new products is data-driven. The final principle BIO laid out is that “political considerations should be put aside by Republicans and Democrats alike.”
Although the U.S. is still in the throes of the COVID-19 pandemic, it’s time for biopharma manufacturers to start thinking about transitioning back to business as usual. That’s the gist of a guidance the FDA released Sept. 11. The guidance, which will remain in effect for the duration of the public health emergency, describes how to evaluate and prioritize the remediation of manufacturing activities that were necessarily delayed, reduced or otherwise modified to maintain production and the drug supply during the pandemic. Measures such as quarantines and social distancing may have been implemented across some companies to prevent the spread of COVID-19. Such measures – coupled with employee illness and absenteeism, travel restrictions, site closures and supply chain disruptions – impacted normal manufacturing operations and current good manufacturing practice activities, the FDA said. The guidance recommends a quality risk-management approach, prioritizing activities related to the production of drugs at risk of shortage, to help manufacturers resume normal operations.
The Institute for Clinical and Economic Review (ICER) released an evidence report assessing the comparative clinical effectiveness and value of targeted immune modulators that treat ulcerative colitis. Included in the ICER report are: Humira (adalimumab, Abbvie Inc.), Simponi (golimumab, Johnson & Johnson), Remicade (infliximab, Johnson & Johnson), Renflexis (infliximab-abda, Merck & Co. Inc.), Inflectra (infliximab-dyyb, Pfizer Inc.), Xeljanz (tofacitinib, Pfizer Inc.), Stelara (ustekinumab) and Entyvio (vedolizumab, Takeda Pharmaceutical Co. Ltd.). The report will be reviewed at a virtual public meeting of the California Technology Assessment Forum on Sept. 24, 2020.
The U.K.’s Medicines and Healthcare Products Regulatory Agency updated its guidance Sept. 7 on drugs that can’t be exported from the U.K. or hoarded. The list, first published in October 2019, now contains nearly 200 drugs, 85% of which were added to the list in 2020. All but a few of the 2020 additions were made in March and April as the COVID-19 pandemic took hold. That’s not to say all the drugs listed this year are due to the pandemic. For example, lithium carbonate, the most recent addition, is used to prevent cluster headaches and to treat manic-depressive disorder and other conditions.