The number of whistle-blower tips and complaints received by the Securities and Exchange Commission reached 3,238 in the 2013 fiscal year, up from 3,001 in the 2012 fiscal year, according to the agency's 2013 Annual Report to Congress on the Dodd-Frank Whistleblower Program. The most common complaint categories were corporate disclosures and financials, with 17.2% of whistle-blower tips and complaints; offering fraud, at 17.1%; and manipulation at 16.2%. The agency issued a $14 million whistle-blower award Sept. 30, its largest to date.
The U.S. FDA announced on Monday 15 grants worth more than $14 million for the development of drugs and medical devices for rare diseases. "The FDA is committed to fostering and encoring the development of products for rare diseases, most of which have no available or adequate treatments," said Gayatri Rao, director of the FDA Office of Orphan Products Development. "The grants awarded this year support studies in very vulnerable, difficult-to-treat populations who have no available options."
NovaDigm Therapeutics raised $14 million in a Series B funding round from Domain Associates and RusnanoMedInvest. The Grand Forks, N.D.-based drugmaker will use the money to continue a midstage trial of its lead product, NVD-3, a vaccine that targets certain bacterial and fungal pathogens.
A financing round has brought in $14 million for Osseon Therapeutics, maker of an inflatable bone tamp that was cleared by the FDA in October. The Santa Rosa, Calif.-based startup will use the money to increase its portfolio of vertebral compression fracture systems.
Nearly 3,000 whistle-blowers have contacted the Securities and Exchange Commission's whistle-blower office since its inception last year, says Commissioner Luis Aguilar. "The quality of the information determines how quickly our staff can act and whether we can increase the odds of capturing true masterminds and whether we can prevent harm from occurring in the first place," he says.