WASHINGTON – Optimism, and eight years of hard work, paid off for Optimer Pharmaceuticals Inc. Tuesday when an FDA advisory committee unanimously recommended approval of Dificid (fidaxomicin) as a treatment for Clostridium difficile infection (CDI).
WASHINGTON – Instead of making all DNA patents vanish or asking judges to pull rabbits out of their hats every time they have to rule on genomic patents, the Department of Justice (DOJ) recommended they use a "magic microscope" as the legal patent test for clarifying when genetic material is a product of nature.
Intercept Pharmaceuticals Inc. is soaring, now that it has an expanded runway and a flight plan to Asia via its first strategic partner worth a potential $315 million.
WASHINGTON – Things should be a little quieter at the FDA this week as new safety reporting requirements go into effect to reduce the "noise" from the overreporting of individual serious adverse events in clinical trials
Tekmira Pharmaceuticals Corp. filing a complaint alleging misappropriation of information and seeking potentially more than $1 billion in damages from RNAi partner Alnylam Pharmaceuticals Inc. might seem like a bad dream. After all, the horror stories of partnerships gone bad are the stuff of nightmares for biopharmaceutical companies looking for the right mate to advance a product.
A U.S. Supreme Court ruling will have biopharmaceutical companies walking a fine line when it comes to disclosing adverse event reports to their investors, but the court refused to define that line.
WASHINGTON – Hoping the legislative ground is fertile this go around, the Senate is debating a bipartisan bill that would sow more seed capital for small biotechs through the Small Business Innovation Research (SBIR) program.
