Tag Archives: Trouble

More trouble for Biocon insulin plant in Malaysia as FDA flags six Form 483 observations

The road to certification for Biocon’s insulin facility in Malaysia was long, winding and full of potholes. Now comes a detour. The FDA has slapped the factory with Form 483, citing six observations that need to be addressed, the company said. The site makes the high-profile interchangeable insulin Semglee, but Biocon doesn’t expect the latest inspection… Read More »

FDA’s new JAK safety restrictions spell trouble for AbbVie’s Rinvoq, but to what extent?

AbbVie’s megablockbuster Rinvoq ambition suffered a blow thanks to an updated safety warning and treatment restriction from the FDA. But pharma watchers have different opinions on just how significant the impact will be on AbbVie’s JAK inhibitor. In an announcement Wednesday, the FDA is revising Rinvoq’s boxed warning to include information about increased risks of… Read More »

Having trouble sleeping: What to know

Sleeping difficulty refers to difficulty falling asleep, difficulty staying asleep, or waking up too early. Low quality sleep and a lack of sleep can both negatively affect a person’s health. Chronic sleep loss can even lead to headaches, excessive fatigue, and cognitive impairments. Sleeping difficulties may occur due to lifestyle factors, poor sleep hygiene, or… Read More »

Weight-Loss Surgery Protects Heart Patients From Future Trouble

TUESDAY, Nov. 5, 2019 — If you’re an obese heart patient, weight-loss surgery might be good medicine for you. New research suggests it significantly reduces the risk of heart failure and fatal heart attack in this vulnerable group. “Our findings suggest, for the first time, that bariatric [weight-loss] surgery can prevent the development of systolic… Read More »