Although the FDA suggested in May that it might have trouble meeting PDUFA dates due to the COVID-19 pandemic, the 30 approvals of biologics and drugs handed down in June 2020 is the highest number for a single month in the past five years.
While biopharmaceutical research is currently concentrating on the threat posed by the COVID-19 pandemic, the disease has provided a sharp reminder that our focus should not be lost on infectious diseases as a whole, along with the growing global problem of antibiotic resistance (AMR), which has the potential to dwarf COVID-19 in terms of deaths and economic costs, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
In case you haven't heard, Tessera Therapeutics Inc. is working on techniques to write genes into the genome of patients. Tessera, which was developed in Flagship Pioneering Inc.'s Flagship Labs and became a stand-alone incorporated company two years ago, recently came out of stealth mode to highlight its Gene Writing platform based on mobile genetic elements, such as transposons and retrotransposons.
As society continues to re-open and biopharma companies move back toward a business-as-usual approach, the number of clinical trials affected by the COVID-19 pandemic has plummeted with only 12 reporting delays or disruptions in the month of June. This compares to 171 in April and 71 in May.