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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
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
Unit-level tracking “is likely more fit” for investigations of substandard and illicit drug products, cargo theft and diversion, the WHO said. Read More
The FDA details how sponsors of nonclinical safety evaluations of new drugs and therapeutic proteins should consider their impact on the immune system, in a draft guidance released yesterday. Read More