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.
WASHINGTON – Concerns about a nuclear meltdown in Fukushima, Japan, are producing a global reaction as countries rethink their use of nuclear technology and frightened consumers stock up on potassium iodide tablets, one of the only drugs available that can ward off a few of the health effects of exposure to excessive radiation.
In the wake of a tsunami that's claimed thousands of lives, triggered threats of potential nuclear meltdowns and destroyed the infrastructure in cities along Japan's northeastern coastline, the biopharmaceutical industry in Japan is taking stock of its damages.
WASHINGTON – One company's gain could be another's loss if the FDA raises the financial resources threshold for user fee waivers for drugs and biologics.
A $165 million underwriting agreement may be the prescription Exelixis Inc. needs to get its cancer candidate, cabozantinib, through clinical development.
WASHINGTON – One of the intended casualties of the patent reform bill the Senate passed Tuesday is the years-long wait for the Patent and Trademark Office (PTO) to review a patent application.