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).
Recognizing that an initial public offering (IPO) isn’t the best route for all small companies in need of capital, the Equity Capital Formation Task Force is pushing the SEC to lift the barriers on Regulation A offerings immediately.
Now that generic drugs are a fully grown industry in the U.S., the FDA said it’s time for generic drugmakers to take responsibility for the labeling of their products and face the same liability as the makers of brand drugs and biologics.
Just in time for the holidays, the FTC is gifting itself on the biopharma industry by finalizing a change to its premerger notification rule that makes transfers of “all commercially significant rights” to drug, biologic and in vitro diagnostic patents subject to antitrust review under the Hart Scott Rodino (HSR) Act.
What could be the first chapter in a sequel to the Jumpstart Our Business Startups (JOBS) Act was unveiled Wednesday with the hope that it soon will become a congressional best-seller that will stimulate investment in groundbreaking R&D.
Biopharma regulators across Asia are undergoing major restructuring as China, India and other countries seek to protect their share of drug exports in the face of stiffer manufacturing compliance demands in the West and pressure to adopt international standards.
All the hurdles in developing drugs to fight cancer in children came to the fore this week as the Pediatric Oncology Subcommittee of the FDA’s Oncology Drugs Advisory Committee (ODAC) grappled with the unknowns of science and a pressing unmet need as they discussed global pediatric development plans for Bristol-Myers Squibb Co.’s (BMS) nivolumab, Merck Sharp and Dohme’s MK-3475 and Novartis Pharmaceuticals Corp.’s LEE011.
