WASHINGTON – Flexing its regulatory discretion, the FDA curbed two critical cancer drug shortages by speeding approval of a new source for preservative-free methotrexate and allowing the temporary importation of Lipodox as an alternative to Doxil.
WASHINGTON – Armed with more information about cardiovascular and teratogenic risks, as well as a less restrictive risk evaluation and mitigation strategy (REMS), Vivus Inc. is prepared for a second performance before the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).
The 800-pound gorilla in the Patent and Trademark Office (PTO) hearing on genetic diagnostic tests was Myriad Genetics Inc. – even though the Salt Lake City-based company wasn't on the agenda.
Unlike every other country in the world at the time, the U.S. founded its judicial system on the premise “innocent until proven guilty.” Under that guiding principle, the burden of proof – in any enforcement action – lies with the government. That principle has served the nation well for nearly 250 years. But now the FDA is seeking a congressional blessing to change it, under the guise of drug safety. Testifying before a House subcommittee last week, the FDA’s Janet Woodcock noted the stress placed on the agency because it bears the burden of proof when it comes to the...
WASHINGTON – The Supreme Court is set to consider Friday whether it wants the last word on the patentability of Myriad Genetics Inc.'s claims on the BRCA1 and BRCA2 genes, used in diagnostics for breast and ovarian cancer.
WASHINGTON – Dealing with pain has been a routine part of life for millions of Americans. Now, it's being bumped up to a national priority with a focus on treating it as a complex disease in itself.
WASHINGTON – If the FDA gets its way, it will see a 17 percent increase in its 2013 budget, but nearly all of that will be footed by the biopharma and food industry through new and increased user fees.
WASHINGTON – While the package of draft guidances the FDA released last week on biosimilars held no surprises, it also was light on the specifics needed to produce predictability in the new pathway.
