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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
The EU Parliament advanced major data privacy legislation, but not before amending two provisions that pharma companies had said would cripple clinical research. Read More
GlaxoSmithKline says it is under investigation in Poland for allegedly bribing doctors to promote the asthma drug Seretide (fluticasone propionate/salmeterol xinafoate). Read More
The UK’s Medicines and Healthcare products Regulatory Agency has created a pathway to speed life-saving drugs to patients via an early-access program similar to the U.S. Food and Drug Administration’s popular breakthrough therapy initiative. Read More
Manufacturers of influenza vaccine in the EU must file strain variation applications for next year’s flu season by June 16, the European Medicines Agency says. Read More
Actavis and Pfizer say they have settled all patent litigation over the generic version of painkiller Celebrex, which may clear the way for Actavis to start marketing its version of the drug before the end of the year. Read More
Massachusetts doctors who want to prescribe the painkiller Zohydro will need to complete a risk-assessment and pain management treatment agreement with their patients, under sweeping restrictions announced Tuesday by Gov. Deval Patrick (D). Read More
Pfizer Monday reached an agreement to settle a class action lawsuit alleging that the drugmaker attempted to improperly delay the launch of generics of its epilepsy drug Neurontin. Read More
Israeli drugmaker Teva announced April 17 that it has reached a settlement with Pfizer to hold back marketing generic Celebrex (celecoxib) in the U.S. until December. Read More
U.S. lawmakers are asking the Office of the United States Trade Representative to put Canada back on its priority watch list after the country withdrew a number of patents for drugs sold by American drugmakers. Read More