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Australia’s Therapeutic Goods Administration is proposing expedited drug application reviews that would mirror programs in North America and Europe. Read More
The European Directorate for the Quality of Medicines and a number of foreign pharmaceutical authorities have agreed to improve information-sharing efforts and to strengthen collaboration. Read More
A proposal to extend the market exclusivity of new drugs approved in India from four years to 10 is dividing the industry, as some argue that the measure would promote safety and others contend it delays generic competition. Read More
Prospects look somewhat grim for the life sciences industry in the UK, regardless of whether the country decides to completely divorce itself from the EU or do a “soft exit,” a think tank says. Read More
The PTO’s Patient Trial and Appeal Board said it was not persuaded by Coherus Biosciences’ challenge over the patentability of methods for manufacturing Humira, and ruled in favor of AbbVie in a trial proceeding. Read More
Teva Pharmaceuticals is reserving roughly $520 million to settle bribery allegations across three countries, according to the company’s latest earnings report. Read More
The U.S. Supreme Court refused to hear appeals brought by Purdue Pharma LP for a patent infringement case centered on reformulations of the painkiller OxyContin, clearing several barriers to the development of generics. Read More
The EMA is revising nearly decade-old guidelines on first-in-human trials after a patient died in a French study earlier this year to offer drugmakers guidance on risk management. Read More