The FDA has released final guidance marking the agency’s adoption of the International Council for Harmonization (ICH)’s E8(R1) guidelines on clinical trials, which call for a “quality by design” approach.…

Many biopharmaceutical sponsors are prepared to see the costs of outsourcing increase for their clinical trials in 2022 as the practice is expected to significantly increase this year, according to…

Sensory Cloud of Boston, Mass., has received a warning letter from the FDA for promoting an unapproved saline spray device as a COVID-19 treatment. Source: Drug Industry Daily

The FDA is reaching out to states that have filed applications with the agency seeking approval to directly import prescription medicines from Canada. Source: Drug Industry Daily

Alzheimer’s disease drug Aduhelm and other investigational anti-amyloid antibodies similar to Aduhelm will only be covered by Medicare and Medicaid if they’re used in the setting of a federally approved…

Generics and biosimilars will slow the overall pace of drug spending growth this year, even though U.S. prescription drug spending is slated to rise by 4 to 6 percent year-over-year…

The UK’s National Institute for Clinical Excellence (NICE) voted down a recommendation for Gilead Sciences’ chemotherapy drug aimed at triple-negative breast cancer, but approved Merck KGaA’s Bavencio (avelumab), which fought…

Pfizer announced yesterday that it would acquire ReViral in a $525 million deal that will give the company ownership of ReViral’s experimental treatments for respiratory syncytial virus (RSV) infections. Source:…

Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni outlined the center’s budget priorities in fiscal year 2023 in a webinar hosted this week by the Alliance for a…

Repeated COVID-19 boosters simply aren’t a practical way to deal with the shape-shifting SARS-CoV-2 virus, according to members of the FDA’s Vaccines and Related Biologics Advisory Committee. Source: Drug Industry…