Topic:

Drug Safety

Latest Headlines

Latest Headlines

No red flags in Januvia heart study means a big win for Merck

Last month, Merck & Co. said Januvia passed its heart safety test. Now, the much-anticipated TECOS trial has had its airing at the American Diabetes Association meeting, and the study authors say the drug is in the clear.

FDA demands new warnings on dermal fillers from Actavis, Galderma

Dermal fillers are meant to minimize the appearance of wrinkles and give the face a smoother, fuller appearance. But they may also have some nasty consequences if injected incorrectly, and so the FDA is calling for some updated labeling on the products.

UPDATED: Suicide stunner prompts Amgen to dump brodalumab, denting AstraZeneca's rep

A month ago, Amgen and AstraZeneca were confidently rolling up data from three highly touted late-stage studies on the psoriasis drug brodalumab for a new drug application that was widely viewed as a shoo-in at the FDA. But late Friday evening, Amgen abruptly said it was pulling out of the long-running collaboration on the high-profile IL-17 program after evaluating the likely commercial impact it would face in light of the suicidal thoughts some patients reported during the studies.

ProPublica: Safety questions over GSK's Advair linger after years on the asthma throne

U.S. regulators gave GlaxoSmithKline's Advair the green light a decade and a half ago, paving the way for a long reign that saw the med grow to more than $8 billion in annual sales. But even after all these years, whether Advair poses a higher risk of asthma-related death remains unclear, ProPublica says.

Fund grows to $200M for victims of meningitis outbreak tied to compounder

A fund for victims of a fungal meningitis outbreak that sprung from contaminated drugs sold by the now-defunct New England Compounding Center has reached $200 million, twice what was initially expected.

FDA proposes new rules for animal drug compounding

On May 17, the FDA announced that it released a draft guidance that sets out rules for compounding animal drugs from bulk substances. In so doing, the FDA is recognizing that in some situations, treating animals with specially formulated versions of approved drugs would be impossible.

FDA makes strides in inspection effort but challenges persist

In a report to Congress this week, the Office of Inspector General said that the number of inspections of generic drugmakers, preapproval and so-called surveillance inspections, were up to 243 in 2013 from 149 in 2011, a 63% jump. The vast majority of those were combined inspections for both preapproval applications and to check on general GMP conditions.

Attix Pharmaceuticals recalls hundreds of APIs from the U.S.

A Canadian-based company that sources active pharmaceutical ingredients from China and repackages them in Toronto is recalling hundreds of bulk APIs sold in the past three years because the facility where they were packaged didn't adequately separate penicillin APIs from the rest.

It's official: Takeda to pay a 'bargain' $2.3B to settle Actos lawsuits

Takeda is preparing to pony up $2.3 billion to settle lawsuits accusing the Japanese pharma of hiding diabetes med Actos' cancer risks. But according to some experts, that's a steal.

3M says its new intravenous port dressing will make drug delivery easier and fight off site infections

3M announced the launch of its Tegarderm CHG intravenous port dressing, saying the device will help oncology patients receive injections comfortably and ward off infection. The new product combines a transparent port-site dressing with a chlorhexidine gluconate gel pad. 3M says the dressing enables continuous, unobstructed observation of the IV insertion site.