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The Supreme Court of Canada struck down the “promise doctrine” used in the evaluation of a patent’s validity — a victory for the pharmaceutical industry, which said its use has led to the cancellation of over two dozen drug patents in the country over the past ten years. Read More
The Supreme Court’s ruling this week on a patent dispute over printer toner cartridges could have wider effects on the pharmaceutical industry, international sales and product reimportation. Read More
China has joined the ICH as its eighth regulatory member, pledging to gradually transform its pharmaceutical regulatory authorities, industry and research institutions to implement the international coalition’s technical standards and guidelines. Read More
The European Medicines Agency has decided to postpone the implementation of its Clinical Trials Regulation from October of next year to 2019 at the earliest, due to technical difficulties. Read More
An FDA advisory committee voted unanimously Wednesday in favor of the risk-benefit profile for Novartis’ BLA for an innovative new cancer therapy. Read More
Officials from Kentucky, Maryland, Rhode Island and Virginia testified to a house committee yesterday about the opioid epidemic in their states and asked for more assistance to combat the problem. Read More
The House passed its version of the FDA user fee reauthorization package Wednesday that is expected to bring in $1.42 billion in fiscal 2018, by a voice vote. Read More
The House Appropriations Committee on Wednesday approved a bill by voice vote that would provide a total of $5.2 billion for the FDA in fiscal 2018—$2.6 billion in discretionary spending with the remainder coming from user fees. Read More
The products include HIV antiretroviral therapies and combinations, a treatment for major depressive disorder and a chemotherapy approved in non-small cell lung cancer. Read More