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Gilead Sciences could soon lose its dominance of the hepatitis C market, as payers hint they may abandon the company’s blockbuster Sovaldi in favor of lower-cost alternatives that are expected to launch in the coming months. Read More
The FDA has cleared new prescribing information for Sanofi Pasteur’s Fluzone High-Dose influenza vaccine, indicating it provides improved protection for adults 65 years and older. Read More
AstraZeneca has filed a patent infringement lawsuit against Actavis subsidiary Watson over a proposed generic version of AZ’s diabetes drug Kombiglyze XR. Read More
Health Canada has expanded its initial import ban on Apotex’s finished product facility in Bangalore, India, to include the generics makers’ raw materials plant in the city. The agency also banned products from another India firm. Read More
The FDA warned a Georgia-based compounder and repackager for poor cleaning practices that apparently led to patients becoming infected by contaminated products. Read More
Drugmakers Sagent and Baxter Healthcare recently recalled products due to labeling mix-ups, a common quality problem that one expert says can be easily solved through an additional examination by personnel. Read More
FDA investigators are finding unprecedented data integrity problems at contract and active pharmaceutical ingredient manufacturers, even after they have been audited by the firms that hired them, an FDA official said. Read More
The FDA issued a warning letter to injectables giant Hospira after an investigation of its Victoria, Australia, plant uncovered significant GMP violations, including a failure to adequately investigate failed batches and determine levels of impurities in distributed products. Read More
The FDA slammed a Chinese active pharmaceutical ingredient (API) manufacturer for using a supplier of potentially contaminated heparin and for restricting access during an inspection. Read More
Drugmakers should upgrade their quality assurance systems to quickly identify and fix any manufacturing problems that could spiral into a shortage, according to a wide-ranging plan to address shortfalls in drug supplies. Read More
Drugmakers may soon have to report to the FDA how they decide when to launch a corrective or preventive action (CAPA) investigation, if they have a performance index for their product’s critical quality attributes and the seniority level of the employee who signs off on the annual product review. Read More