Topic:
Regulatory
Latest Headlines
Latest Headlines
Device tax repeal would cost $30B over a decade, CBO says
As the U.S. House of Representatives gears up to vote on a bill that would repeal the 2.3% device industry tax this week, the Congressional Budget Office says the measure will place a hefty price tag on the federal budget.
Abbott opens the books on pharma spinoff
Pharma breakup followers, take note: Abbott Laboratories ($ABT) has unveiled its first-draft documents for the AbbVie spinoff. In a letter to shareholders filed with the Securities and Exchange Commission, Abbott discloses its management team, sets forth pro forma financials, and runs down the trends on product sales.
Auxogyn reels in $18M to fuel IVF/embryo viability test
Auxogyn has reeled in $18 million in Series B funding to help bring its diagnostic test to evaluate embryo viability during in vitro fertilization to the regulatory finish line in a big advance for the field.
Some drug recalls slip through FDA-reporting cracks
The FDA needs a new recall-alert system, researchers say. That's because some drug recalls--even the most serious, Class I type--haven't been adequately aired.
FDA fails to send alerts on 20% of Class I drug recalls
Between 2004 and 2011, nearly 20% of the Class I drugs recalls were not included in either of the agency's two alert systems, reports Reuters .
ASCO lobbies for fines to combat drug shortages
Although oncologists say shortages have eased a bit, some key chemo drugs are still scarce, most of them generics, the Wall Street Journal Health Blog reports.
Ceptaris Therapeutics raises $10M after FDA denial
Venture backers are giving Ceptaris Therapeutics another chance. Fresh from an FDA rejection of the small developer's cancer drug, Ceptaris has found $10 million in a Series D-1 round.
Appeals court reinstates KV investors' $1.5B lawsuit
A U.S. appeals court resuscitated a $1.5 billion securities fraud lawsuit dismissed back in 2010, Reuters reports. And KV isn't the only drugmaker that should be worried about the court's ruling, the investors' lawyer says.
EU homes in on track and trace rules
The European Union is embarking on a track and trace system to try to foil counterfeiters, which when implemented in 2014, will include unique identifiers on each individual package of drugs. The process will be closely watched in the U.S. where a similar system could end up in the pending FDA reauthorization legislation.
FDA foresees jump in apps for cancer drugs
With developers finding ways to get early readouts on efficacy, companies are expediting programs to set the stage for rapid development and speedy approvals of new anti-cancer therapies.
