Intercept Pharmaceuticals Inc. is looking to a $163 million collaboration agreement with Les Laboratoires Servier to help it scale the mountainous challenges involved in developing a novel diabetes drug.
All those warnings about price pressures and reimbursement woes – they didn’t come from Chicken Little. The sky really could be falling for drugmakers that insist on pricing their products based on what the market used to bear. Rather than making the same old arguments about the cost of drug development, biopharma needs to understand that today’s market simply can’t bear the prices of yesterday’s bestsellers. Yes, a lot of factors are involved in drug pricing, and a lot of middle men add to the costs here in the U.S. But when it comes finger-pointing time, drugmakers tend to be...
WASHINGTON – Fears that the FDA and National Institutes of Health (NIH) may loosen researchers' collars on conflicts of interest have government watchdogs nipping at their heels.
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.
