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The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Read More
BioMarin is calling it quits for its Duchenne muscular dystrophy candidate and three related products in its pipeline after the EMA’s Committee for Medicinal Products for Human Use signaled that it would not back the candidate. Read More
An Indian court is ordering Pfizer to honor an earlier promise to dump large quantities of its steroid Medrol prior to the drug’s expiration date. Read More
Italian regulatory authorities have cited two Indian drugmakers for dozens of GMP issues, ranging from data security to quality management issues. Read More
The UK’s National Institute for Health and Care Excellence refused to recommend Janssen’s chronic lymphocytic leukemia treatment Imbruvica for reimbursement in June, but left the door open to further discussion. Read More
While retail prices for cancer drugs may be the highest in the U.S., these medicines appear to be less affordable in poorer countries such as India and China despite their lower prices, according to a study. Read More
Colombia’s Ministry of Health and Social Protection announced its plans to unilaterally cut the price of Novartis’ myeloid leukemia treatment Gleevec after negotiations with the Swiss drugmaker fell through the cracks. Read More
France is tightening restrictions on early-phase clinical trials in the wake of one study that left one patient brain-dead and hospitalized five others. Read More