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European drugmakers say they support recent EU efforts to fight counterfeiting, but would like to see some changes to a provision that aims to catch fake products as they move across member-state borders. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval following its recent meeting, including products to treat intolerance to sunlight, ovarian cancer, oestrogen deficiency and hemophilia B. Read More
Drugmakers may soon have to report to the FDA how they decide when to launch a corrective or preventive action (CAPA) investigation, if they have a performance index for their product’s critical quality attributes and the seniority level of the employee who signs off on the annual product review. Read More
The UK’s cost-effectiveness watchdog has recommended coverage of Bayer’s blood thinner Xarelto for preventing blood clots in people who have had a heart attack based on evidence the drug can decrease the cardiovascular risk by up to 20 percent. Read More
European regulators say they are prepared to start a continual assessment of data on experimental Ebola treatments as soon as they receive each submission. Read More
To avert drug shortages, Health Canada has partially lifted an import ban on products from three Indian manufacturing facilities that were barred from doing business in the country due to quality violations. Read More
The president-elect of the European Commission said yesterday that oversight of EU drug policy will remain under the health directorate, marking an about face on a decision last month that would have switched the responsibility to the industry department. Read More
Takeda has asked a federal court to rescind the FDA’s approval last month of Hikma Pharmaceutical’s gout treatment Mitigare, claiming that the agency improperly cleared the rival company’s drug application without referencing Takeda’s own gout therapy Colcrys or its safety warnings. Read More
The FDA wants to understand how patient perceptions of medications change when pharmacies switch from brand to generic products or between the same generics made by different manufacturers. Read More
Spectrum Pharmaceuticals wants an extra four months of market exclusivity on its cancer drug Fusilev, arguing the FDA’s delay in approving the drug’s name entitles it to a revised approval clock. Read More
The U.S. Trade Representative’s Office has launched a review of India’s intellectual property regime that will focus in large part on pharmaceutical IP issues, including the country’s policy of providing access to affordable medicines. Read More