The nonprofit generic drugmaker Civica said that it’s going to manufacture three different insulin biosimilars that, if approved, will be distributed at prices that are “significantly lower” than the cost…

AstraZeneca’s and Sanofi’s investigational long-acting antibody aimed at infants with respiratory syncytial virus (RSV) had positive results in its phase 3 trial, making it the first potential immunization to show…

Gantenerumab, another anti-amyloid antibody, is entering the race to find an effective therapy for Alzheimer’s disease (AD), with an ambitious four-year study in presymptomatic, amyloid-positive subjects. Source: Drug Industry Daily

To clarify the FDA’s recommendations on quickly and effectively removing potentially harmful drugs and devices from the market, the agency has published a final guidance focused on recall readiness. Source:…

The FDA has begun releasing a court-mandated trove of documents pertaining to the agency’s review of Pfizer/BioNTech’s COVID-19 vaccine — which the agency authorized for emergency use in December 2020…

The Sackler family and OxyContin maker Purdue Pharma have agreed to pay $6 billion in a revised bankruptcy settlement proposal with a group of holdout states who appealed a previously…

In his State of the Union address on Tuesday, President Joe Biden reiterated his desire to drive down the price of pharmaceuticals in the U.S., a move that was thwarted…

Sanofi reported that the average net price in its U.S. drugs after rebates and discounts decreased by 1.3 percent in 2021, continuing a six-year downward trend. Source: Drug Industry Daily

The FDA is making moves to improve how oncology trials are designed and conducted, publishing three final guidances on master protocol trials, first-in-human trials with expansion cohorts and the inclusion…

Christopher A. Williamson, president of Vi-tal Health and Wellness, received a Feb. 15 warning letter from the FDA stating that ingredients in the product Dr. Miller’s Holistic Premium Holy Tea…