In a 1993 clinical trial of fialuridine--a drug originally designed as a therapy for hepatitis B--5 out of 15 patients died from sudden liver failure. A new study in PLOS Medicine found that mice with humanized livers demonstrate the drug's toxicity.
Cubist Pharmaceuticals has again been tripped up by one of its contractors, having to recall a single lot of its injectable antibiotic Cubicin because of particulate. The recall comes 8 months after a similar problem led it to recall four lots of the drug.
Sterile injectable drug maker Hospira last year ramped up production of the sedative and analgesic propofol, a drug CEO F. Michael Ball said he knew the market was anxious to see a bigger supply of. But the drugmaker is now recalling 7 lots of the drug because glass and metal particles have been found in some vial samples.
The FDA has lifted a clinical hold placed on a study at Memorial Sloan-Kettering of Juno Therapeutics' cutting-edge approach to treating cancer using genetically tailored T cells, FierceBiotech has learned.
After last week expressing her opinion that Massachusetts Governor Deval Patrick was "out of line" with his move to block controversial superstrength painkiller Zohydro, U.S. District Court Judge Rya Zobel granted maker Zogenix's request for an injunction temporarily halting the ban.
With big money to be made, drugmakers have responded to the global rise in Type 2 diabetes with a host of new classes of treatments that work in different ways. And while that is generally a good thing, the full range of adverse effects of all of these new drugs can't be known until they have been on the market for awhile, and some will fare better than others, a new report states.
The FDA has been reviewing testosterone drugs since January of this year on concerns over their cardiovascular safety. Now, its across-the-pond counterpart is following suit, embarking on its own review following worrisome study data.
In late March, Massachusetts Governor Deval Patrick banned the newly approved purely hydrocodone pain pill Zohydro--and now the maker of that drug is fighting back. Zogenix filed a lawsuit in a Boston federal court seeking a restraining order against the governor's Zohydro ban.
A study the FDA has cited as a reason to investigate the cardiovascular safety of testosterone drugs has come under heavy fire from critics. Physicians and researchers are calling for the November paper's retraction, citing at least two corrections that they say compromise its credibility.
GlaxoSmithKline is recalling supplies of its OTC weight-loss drug alli in light of reports from U.S. consumers who found the wrong drug when they opened their bottles.