FDAnews Drug Daily Bulletin

Drugmakers striving to comply with manufacturing regs and stay on the FDA’s good side should turn their attention to preventing human error, an industry official says — and automated systems are key to solving this problem.

Drugmakers and regulators can be more confident about the rigor of trial data coming from emerging markets as the quality of studies appears to be on par with trials in more research savvy, developed nations, a new study concludes.

KV Pharmaceuticals has sued the FDA to force it to stop pharmacies from compounding KV’s preterm birth drug Makena.

The road to a sleeping pill that offers the snooze-inducing benefits of Ambien and Lunesta, while avoiding next-day grogginess and disorientation, has been paved with failure, tripping up GlaxoSmithKline and Takeda Pharmaceutical.

A new federally funded study will look at the use of another type of HIV drug in healthy people with the aim of preventing them from becoming infected with virus that causes AIDS.

On the day Jim Lenox got his last injection, the frail 54-year-old cancer patient was waiting to be discharged from the Baltimore Washington Medical Center.

European regulators have recommended approval of the Western world’s first gene therapy drug — after rejecting it on three previous occasions — in a significant advance for the novel medical technology.

Two Republican lawmakers urged federal health officials to update their definition of “patient” in a discount drug program that serves low-income patients, a program whose rapid growth has drawn scrutiny from both Congress and a government watchdog.

In a joint press release, labor union Unia and management of biotech firm Merck Serono stated that they could not come to terms in a mediation process over the company’s soon-to-be shuttered headquarters in Geneva.