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The FDA hit a South Korean drug manufacturer for serious violations at its Chuncheon, Gangwon facility, including lax investigations and testing deficiencies. Read More
The World Health Organization (WHO) has launched a pilot program aimed at increasing insulin access by prequalifying biotherapeutic products that contain human insulin as an active ingredient. 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
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) wrote up a drug manufacturer in Bangalore, India for data integrity and other serious violations observed during a December 13 inspection. 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 FDA has released a new table listing certain gene-drug interactions backed by scientific evidence that appear on agency-approved drug labeling. Read More