WASHINGTON – Immunosyn Corp.'s statements in public filings over the past few years have landed the biotech, its shareholders and senior executives on the wrong side of the SEC.
Science and the FDA are paving a way for personalized medicine, but whether there's a will to turn that way into a thriving thoroughfare remains to be seen.
The Federal Circuit giveth, and it taketh away in deciding a challenge to the patentability of Myriad Genetics Inc.'s BRACAnalysis, a breast cancer gene test.
WASHINGTON – Recognizing what's at stake, a Senate committee is preparing the ground for PDUFA V, even though the FDA won't submit the next five-year drug user fee plan until January.
WASHINGTON – Noting the shifting winds of federal stem cell policy, a district court has dismissed a case challenging the National Institute of Health's (NIH) funding of human embryonic stem cell (hESC) research.
WASHINGTON – In what appears to be one long brainstorming session on ways to restrict drug costs while increasing access to promising therapies and creating U.S.-based jobs, lawmakers are introducing a myriad of bills that range from revising Medicare reimbursement to changing how biopharma does business.
A policy climate change brought on by deficit talks and health care reform could make the U.S. market-based approach to drug pricing an endangered species.
