Tag:
drug safety
Latest Headlines
Latest Headlines
Ranbaxy inks record-setting $500M manufacturing settlement with the feds
The India-based generics maker pleaded guilty to U.S. drug safety violations and agreed to pay $500 million in penalties, in the largest-ever federal settlement with a maker of copycat drugs.
Pfizer has another recall tied to smelly drugs
Smelly pills have led to another recall by Pfizer and this time a drug shortage. Last year Pfizer recalled more than 650,000 bottles of Advil gel tabs from stores because they had a strong odor. This time it is Pfizer subsidiary King Pharmaceuticals recalling 52,000 bottles of its thyroid pill Levoxyl because of a bad odor.
Chinese court wants tougher clinical trial regs
India's struggles to regulate its booming clinical research industry are well told, but now China could be headed down the same path, as a Beijing court has taken issue with how trial-runners pay compensation to patients.
Troubled BioCryst dumps HCV preclinical program
Troubled BioCryst Pharmaceuticals has ditched its preclinical hepatitis C virus program of BCX5191 and its backup compounds after results of a low-dose chimpanzee study, according to documents filed with the SEC.
Generic Reglan user can sue Pfizer for damages
It's a state court ruling. It directly affects only one drugmaker. But the Alabama Supreme Court's decision to allow a patient to sue Pfizer for damages could ripple through the industry--and not in a good way for branded drugmakers.
Pakistan investigates cough syrup tied to 35 deaths
An investigation into the deaths of 35 people in Gujranwala, Pakistan, tied to a cough syrup has sparked a controversy over who is to blame.
Congressional bills would toughen safety labeling for generic drugmakers
Congressional Democrats are ramping up two bills intended to put generic drugmakers on par with their Big Pharma counterparts as far as governing how they change product labeling to report updated safety information.
Health Canada tells hospitals to quarantine morphine from Sandoz
Sandoz Canada is in the spotlight again this week after Canadian health officials told hospitals to quarantine boxes of the company's injectable morphine after one was found to contain another drug.
Gilenya market share drops after FDA review
An FDA safety review is taking its toll on Gilenya sales. The Novartis ( $NVS ) multiple sclerosis pill, the first oral therapy for the debilitating disease, lost market share in January after reports that some patients died while using the drug.
Novartis to revamp Rasilez label with safety risks
The data on Rasilez 's safety risks is coming home to roost. The Novartis ( $NVS ) blood-pressure drug will get a new warning in Europe at regulators' request, after a recent trial flagged links...
