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A blockchain-based drug tracking network is capable of meeting future supply chain regulatory requirements, according to pharma companies that took part in a pilot program run by the FDA. Read More
The FDA released a new version of its Purple Book for biological product developers in a searchable database that links each biosimilar and interchangeable with its reference product. Read More
Washington, Wisconsin and Minnesota advanced new efforts last week aimed at lowering prescription drug prices, joining more than 128 drug pricing bills making their way through legislatures across the country. Read More
In a further blow to Gilead, the U.S. Patent Trial and Appeal Board (PTAB) denied the company’s request to review two HHS patents for the use of Truvada (emtricitabine/tenofovir) for prevention of HIV infection. Read More
The FDA issued a final guidance on online submissions for certain drug product applications, clarifying that some submission types are exempt or may qualify for a waiver. Read More
The U.S. is bearing the brunt of pharmaceutical research costs because of “free-riding” by foreign countries in the past 15 years, the White House Council of Economic Advisers (CEA) claimed in a new report released yesterday. Read More
The sharp increase in FDA warning letters to Indian facilities last year will lead to a significant delay in U.S. generic launches by Indian drugmakers, according to CRISIL, an Indian research firm. Read More