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Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. Read More
The European Medicines Agency is looking into potential heart risks linked to testosterone-containing drugs after an EU member state regulator raised safety concerns. Read More
Although great strides have been made by Chinese officials to improve the quality of drugs made in the country, more needs to be done, according to U.S. regulators and drug safety advocates. Read More
Merck is reporting strong mid-stage trial results for a drug combo to treat hepatitis C, which may position it to be the strongest alternative to Gilead’s Sovaldi. Read More
India is proposing revisions to its patent system that drugmakers say will chill innovation and further undermine the drug industry’s ability to protect its intellectual property in the country. Read More
The EMA is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More
The World Health Organization lashed out at Johnson & Johnson and Gilead for selling oral hepatitis C drugs that are too expensive to be adopted in developing countries. Read More
The European Medicines Agency is planning a series of May meetings with industry to unveil the process it plans to use to determine whether clinical trial data is considered confidential under its new transparency rules or whether it must be disclosed. Read More