Iowa's KemPharm, maker of abuse-resistant versions of painkillers, has set its price range for a possible IPO, seeking up to $56 million at $12 to $14 a share.
Pfizer researchers found evidence last year that pregnant women using its Zoloft antidepressant had a higher risk of giving birth to a child with heart problems and other congenital anomalies, Bloomberg reports. Now, the internal report has surfaced in a lawsuit blaming Zoloft for a young boy's heart defect, the first such case to go to trial.
Just weeks after recalling three lots of 0.9% sodium chloride injection amounting to nearly 600,000 units, Baxter has recalled 8 more lots, adding further to the national shortage of saline. Last time the problem was leaky bags. This time the drugmaker says there is a problem with the chance for particulate in the bags. The FDA also announced the recall in a MedWatch notice.
The FDA raised some alarming concerns tied to AstraZeneca's Onglyza ahead of a committee meeting to discuss the safety of so-called DPP-4 inhibitors, sounding a worrying note for a blockbuster class of drugs.
FDA experts will grill a couple of diabetes meds next Tuesday, and the outcome of that debate could put a damper on sales. The drugs: AstraZeneca's Onglyza and Takeda's Nesina, both DPP-4 blood sugar-fighters. The questions: Do they really increase the risk of heart failure? And if so, what's to be done about it?
Drugs that treat brain-related diseases are often tied to troubling side effects. Now an analysis of FDA side-effects reports by healthcare informatics firm AdverseEvents has uncovered more potential safety problems for the meds.
For more than two years, the FDA has been very clear about the standards its expects U.S. drug compounders to maintain and the very harsh penalties that can await those who don't comply. But some still haven't heeded the message, and last week North Carolina authorities closed one and the FDA warned providers not to use any of its products.
The FDA announced Wednesday that Zoetis has agreed to withdraw the arsenic-based drug Histostat (nitarsone) from the market by this fall. The move follows years of pressure from food safety groups concerned that the drug--used to prevent blackhead disease in poultry--could endanger human health.
Despite efforts by major pet retailers to remove China-made jerky treats for pets from stores--moves that were made following an outbreak of a rare kidney disease in dogs called Fanconi, which was tied to chicken jerky--the illness is still being reported.
Takeda lost its very first jury trial in 2013 over claims that it didn't sufficiently warn patients of the cancer risks of its diabetes drug Actos. Then it and Eli Lilly were hit with a breathtaking $9 billion verdict a year later. Now Takeda is looking to extricate itself from the more than 8,000 lawsuits in the U.S. with a $2.2 billion settlement.