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Mylan reached a settlement with Roche and Genentech that paves the way for the generic drugmaker to market a biosimilar version of the blockbuster drug Herceptin. Read More
The USPTO's Patent Trial and Appeal Board validated four of Acorda’s patents on the multiple sclerosis drug Ampyra, but a federal court still has to determine whether five of the drug’s patents are valid before generic drugmakers can market versions of Ampyra. Read More
Amgen is calling on the U.S. Supreme Court to rule that biosimilar makers must wait six months after an FDA approval to market their therapy. Read More
Two FDA advisory committees voted Tuesday that the benefits of a previously approved formulation of Opana ER no longer outweigh the risks of abuse. Read More
Australia’s TGA increased first-time inspections of drug manufacturing facilities by 16 percent in the second half of 2016 compared to the same period a year earlier, according to the agency’s latest performance report. Read More
India’s Ministry of Health is proposing that drug regulators and drugmakers implement several measures to improve the quality of drugs in the country’s supply chain, following a government estimate that 10 percent of them are substandard. Read More
Companies want to be able to choose between providing quality metric reports on a more comprehensive product-by-product or less burdensome site-by-site basis. Read More
A Chinese API maker relied on manipulated data and incomplete records to make decisions on batch releases, prompting the FDA to issue a warning letter to the company over data integrity. Read More
More than four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on starting materials for chemical entity drug substances. Read More