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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
The FDA is turning up the heat on drugmakers who don’t pay their generic drug user fees, warning its tenth manufacturer since the summer for delinquent fees. Read More
A trade group of small to medium-sized European brand drugmakers has criticized a Spanish government order that may allow biosimilars to be interchanged with their reference product in the same way that generics may be substituted for brands. Read More
Six months of additional pediatric exclusivity should be granted only to products that add a children-specific indication, and only if the drug sponsor receives a specific written request from the FDA for studies to support the label expansion, according to the American Academy of Pediatrics. Read More
The FDA should make its consideration of ANDA first-filer status a far more public process, say generics firms that continue to seek more transparency and communications from the agency in general on the generic drug application process. Read More