First-time generic approvals April 2011

Aldeyra has resubmitted its new drug application for reproxalap, an investigational dry eye treatment, which contained new data from an additional FDA-requested trial.

In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.

A second patient with Duchenne muscular dystrophy has died from acute liver failure after receiving the gene therapy Elevidys.

In an interview, James D. Chambers, Ph.D., from Tufts Medical Center, talks about the factors that are impacting the biosimilar market.

The FDA has accepted a New Drug Application for zoliflodacin, a first-in-class oral antibiotic for treating uncomplicated gonorrhea, offering a potential new option amid rising antibiotic resistance.

Ibtrozi had a 90% response rate in treatment naïve adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer, according to the results of a news release.