Theranos Shipped Blood Testing Device Under Wrong Risk Classification, FDA Says
The Food and Drug Administration says the start-up company's Capillary Tube Nanotainer (CTN) -- a tiny vial used to collect blood -- should carry a higher-risk classification that requires more oversight. In other marketplace news, Novartis' profits take a hit from a government lawsuit settlement, and the health-sector stock slump hurts hedge-fund managers like Larry Robbins.
Reuters:
FDA Says Theranos Shipping Unapproved Medical Device
The U.S. Food and Drug Administration said privately held laboratory operator Theranos had been shipping a blood testing device under a wrong classification that exempted the product from regulatory control. The device in question is the company's Capillary Tube Nanotainer, a tiny vial used to collect blood from patients. (10/27)
The Wall Street Journal:
Novartis Profit Hurt By U.S. Settlement
Novartis AG said Tuesday that third-quarter profit fell 42% from the same period last year, as the Swiss drug company settled claims that it paid rebates to encourage specialty pharmacies to increase prescriptions. The Basel, Switzerland-based pharmaceuticals company said it has agreed to pay $390 million as part of a settlement with the U.S. Justice Department regarding claims that the company induced specialty pharmacies to boost prescriptions for Novartis drugs by paying kickbacks in the form of rebates. (Roland and Letzing, 10/27)
Reuters:
Novartis Hit By $390M Settlement In U.S. Kickbacks Case
Novartis agreed in principle to pay $390 million to settle U.S. allegations that it used kickbacks to specialty pharmacies to push sales of some drugs, the Swiss company said on Tuesday, hitting third-quarter earnings. The U.S. Department of Justice had sued Novartis in federal court, originally seeking up to $3.35 billion on grounds the world's biggest seller of prescription drugs sought illegally to boost sales of drugs covered by the U.S.-government backed Medicare and Medicaid programs. (Miller, 10/27)
The Wall Street Journal:
Hedge-Fund Billionaire Larry Robbins Takes ‘Punch In The Face’
Billionaire hedge-fund manager Larry Robbins once compared his bets on the success of President Barack Obama’s health-care overhaul to assembling a jigsaw puzzle. But a new slump for many large drug makers is knocking some of those pieces out of place. (Copeland and Hoffman, 10/27)
