Pfizer racked up an important win in the first trial over Zoloft's alleged links to birth defects. A St. Louis jury decided on Friday that the drug giant isn't liable for congenital abnormalities in a boy whose mother took Zoloft during her pregnancy.
Sanofi is suing startup Diagnosia over the publication of information about side effects and drug interactions in its physician decision support software.
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?
AdverseEvents: Analysis of side-effect reports turns up troubling safety signals for Novartis, Eisai drugs
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.