With the FDA backpedaling on a decision it made three years ago to severely limit the use of Glaxosmithkline plc’s (GSK) Avandia and other diabetes drugs containing rosiglitazone, the damage resulting from that decision is calling into question the need for massive cardiovascular outcome trials (CVOTs) for diabetes drugs and the future regulatory role of meta-analysis.
Although Gilead Sciences Inc.’s sofosbuvir could make history as the first interferon-free treatment to be approved for hepatitis C, it may face generic competition in India soon after it hits the market because it isn’t innovative enough, according to some advocacy groups.
Lawmakers are leaving no stone unturned in their struggle to free FDA user fees from indiscriminate sequestration cuts. The latest effort was a letter, sent last week, asking congressional budget negotiators to clearly state in their final agreement Congress’ intent to spare all user fees from the sequester.
No one will benefit from a guardian angel that safeguards investors right out of the market, the SEC was told Thursday at a small business forum on capital formation.
With the sequestration blade set to indiscriminately shave federal programs again in January, a bipartisan group of senators is urging congressional budget negotiators to spare research dollars at the National Institutes of Health (NIH).
Procrastination paid off this time for drugmakers who delayed putting systems in place to comply with a California law requiring half the drugs a company markets in the state to be serialized by 2015.
With sequestration all but wiping out the 6 percent increase the FDA received in drug user fees for fiscal 2013, the agency is struggling to keep up with a medical revolution spurred by scientific advances and the potential of personalized medicine, Janet Woodcock, director of the agency’s drug review center, told a House subcommittee Friday.
A federal judge cut short the first patent dance involving a biosimilar, calling it premature. Judge Maxine Chesney denied Sandoz Inc.’s request for declaratory judgment that the Enbrel (etanercept) biosimilar it’s developing doesn’t infringe two patents owned by Roche AG and exclusively licensed to Amgen Inc.
Despite misgivings about the adequacy and controls of two open-label Phase III trials in evaluating Genzyme Corp.’s Lemtrada in relapsing-remitting multiple sclerosis (MS), the Peripheral and Central Nervous System Drugs Advisory Committee seemed to support approval of the drug, but not as a first-line therapy and only with a strong risk evaluation and mitigation strategy (REMS).
