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The Saudi Food and Drug Authority has set strict new requirements for the import, clearance and export of commercial and investigational drugs, including provisions on drugs for compassionate use and drugs meant for use in clinical trials. Read More
Adding Bristol-Myers Squibb and AbbVie’s immune-based cancer drug elotuzumab to standard therapy extends remission rates for multiple myeloma patients by about four and a half months, compared with standard care alone, data from a late-stage study shows. Read More
The former chairman of the Senate Veterans Affairs Committee is pressing the VA to invoke a wartime provision to break the patents on Gilead Sciences’ pricey hepatitis C drug Sovaldi, after the agency stopped treating veterans because it had exceeded the more than $400 million budgeted for hep C treatment. Read More
The FDA has issued draft guidance spelling out in detail how to prepare and submit an IND if the sponsor is an investigator and not a commercial entity — saying sponsor-investigators often lack the regulatory know-how to submit a proper IND. Read More
The House Energy & Commerce Committee’s health subcommittee Thursday voted unanimously to pass the latest version of the 21st Century Cures Act, which aims to accelerate development of novel therapies to patients with rare diseases through modernized clinical trials and increased funding for research. Read More