With the clock ticking on the urgent need to develop new antibiotics, the ongoing COVID-19 pandemic has given policy makers a sharp reminder that society should not lose focus on antibiotic resistance as well, which has the potential to dwarf COVID-19 in terms of deaths and economic costs. The Centers for Disease Control and Prevention, for example, noted in its Antibiotic Resistance Threats in the U.S. 2019 report that more than 2.8 million antibiotic-resistant infections occur each year, and more than 35,000 people die as a result. Against a universal decline in the effectiveness of antibiotics, there has been a renaissance of interest in using phage therapy, whose use has waxed and waned for almost a century.
The 2017 FDA approval of Luxturna (voretigene neparvovec-rzyl, Roche Holding AG) spurred a race to create the next gene therapy for the eye. The organ is very amenable to gene therapy given that it's a confined space with post-mitotic cells that has immune privilege and requires substantially smaller amounts of viral vector compared to systemic treatments.
In the opening panel of the BIO CEO & Investor digital conference BIO president and CEO Michelle McMurry-Heath explored some of the key issues that are currently impacting the sector with Adena Friedman, president and CEO of Nasdaq, which, this month, marks the 50th anniversary of its launch in 1971.
BioWorld tracked a total of 295 phase I, II and III clinical news items in January, a rise of 39% compared with the number recorded during the pre-pandemic month of January 2020.
January is historically the weakest month of the year for FDA approvals and 2021 is following that trend. With only nine approvals tracked by BioWorld during the month, it falls short of the 12 approvals during the same month in 2020, and it is the lowest amount in a single month since January of 2019, which also recorded nine.
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