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In another blow to Aveo’s oncology pipeline, Astellas announced it is ending a global partnership with the company to develop its troubled cancer drug tivozanib by August 11. Read More
The FDA is investigating whether it is requiring drugmakers to present too much risk information in direct-to-consumer (DTC) television ads, which could lead to a potentially drastic departure from current marketing regulation. Read More
Indian officials are contemplating stripping a number of drugs of their exclusivity periods, clearing the way for companies to produce knock-off products that will bring down costs. Read More
The FDA has upgraded the status of Hospira’s troubled Rocky Mount, N.C., manufacturing plant to allow it to begin using the facility to manufacture new products. Read More
The U.S. Department of Justice wants to rid the pharmaceutical industry of pay-for-performance sales compensation packages, believing they fuel fraud, off-label marketing and other deceptive behaviors, a former top prosecutor says. Read More
Drugmakers should be careful not to use language in product labeling that could be considered promotional, such as comparisons with an alternate treatment, a Health Canada final guidance says. Read More
A U.S. Food and Drug Administration review of drug approvals and denials over a 12-year period shows many delays could be avoided if drugmakers submitted more accurate and useful information. Read More
In a 9-0 decision, the U.S. Supreme Court ruled Jan. 22 that the patent holder bears the burden of proof for infringement, regardless of whether it is the plaintiff or defendant in a patent lawsuit. Read More
Brand drugmakers last month denied accusations they’d joined forces with a lobbying group in a covert campaign to block proposed patent law changes that would improve access to generics in South Africa. Read More
Japanese officials launched an investigation Jan. 10 into claims that falsified clinical trial data were used in an Alzheimer’s study involving several major drugmakers, marking an expansion of the country’s scrutiny of trial data misuse. Read More