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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
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
The FDA issued a final rule amending the definition of “biological product” to include chemically synthesized polypeptides, a category of products that includes all insulins currently on the market. Read More
The FDA slapped a German contract manufacturer with a Form 483 for serious data integrity violations found in an inspection of its facility in Bavaria. Read More