Briefing documents released by the FDA related to the Vaccines and Related Products Advisory Committee meeting slated for Friday suggest that the COVID-19 vaccine from Johnson & Johnson (J&J) will sail smoothly to an emergency use authorization. Read More
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. Read More
RNA has “huge potential” as a therapeutic modality and is beginning to deliver on that potential. But “manufacturing RNA has issues in production, delivery and performance,” Thomas Barnes told BioWorld. Barnes is the CEO of startup Orna Therapeutics LLC, which has the goal of addressing those issues with oRNA, an engineered form of circular RNA. Read More
Drug and device companies dragging their feet on diversifying late-stage clinical trials could conceivably get a wake-up call in court or in FDA approval delays. A final guidance the FDA released in November suggests that the days of ignoring segments of the intended treatment population until safety signals flare in real-world use are coming to an end. Read More
Gilead Sciences Inc. was looking to get into oncology in a big way. Arcus Biosciences Inc. had a pipeline of cancer drugs it didn't want to break up. While a little unusual, the landmark 10-year pact the companies made last year just made sense, company executives explained during a session at Biocom California's Global Life Science Partnering Conference. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aim, Antengene, Kura, Pfizer, RDIF, Teleflex. Read More
