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.
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 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.
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.
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 .
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.
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.
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.
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.
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.