“It’s a rare window into seeing how the FDA makes decisions because the proceedings are open unlike many of the other decisions they make,” Audrey Zhang, a medical student at the New York University School of Medicine, said on why she decided to embark on crunching the numbers from 376 votes by FDA advisory committee meetings from 2008 to 2015.
MEXICO CITY – A hepatitis B virus (HBV) cure was considered “a pipe dream for many years,” Anna Kramvis, of the University of Witwatersrand, told the audience at the 2019 HIV & HBV Cure Forum, co-organized by the International AIDS Society (IAS) Towards an HIV Cure initiative and the International Coalition to Eliminate Hepatitis B (ICE-HBV). Kramvis is also on the board of ICE-HBV
Every year at the Cleveland Clinic Medical Innovation Summit, the Top 10 list of technologies that are predicted to come to the market and change patient care is revealed. Last year's October event saw RNA-based therapies take the No. 10 spot. Certainly, the honor was well earned because, after falling out of favor despite their early promise a few years ago, the technology is now enjoying a major resurgence and the product pipeline is growing once again, driven by increasing investments and business partnerships.
After two complete response letters (CRLs), Agile Therapeutics Inc. with its Twirla (levonorgestrel/ethinyl estradiol) contraceptive patch – hounded by FDA concerns regarding manufacture and adhesion properties – might just be on the road to success.