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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
The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Read More
Mylan is accusing Celgene of violating federal antitrust law by prohibiting the generic drugmaker from obtaining samples of its blockbuster products Thalomid and Revlimid to make generic versions. Read More
Drugmakers must now give Brazil’s ANVISA a full year’s warning before withdrawing a product from the market if the withdrawal could result in a drug shortage. Read More