The FDA is expected to approve it, but some analysts wonder how it will fare if a generic of GlaxoSmithKline's Advair makes it to the market.
Boehringer Ingelheim has won over European regulators with its latest COPD therapy, following a favorable FDA panel vote that set the stage for U.S. approval and entrance into a huge but crowded market.
Xtandi, the prostate cancer drug from Astellas, is a pill, and that is a benefit to patients in the eyes of an independent committee for the U.K.'s price watchdog, NICE. But then, so is Johnson & Johnson's competitor Zytiga, which NICE has already approved. The difference is that Xtandi can be taken after eating, an advantage the makes it more convenient in the eyes of NICE evaluators who have favored its use in the U.K.
The FDA has once more rejected Alimera Sciences and pSivida's drug-device combo for diabetic vision loss, roughly halving the companies' stock value and casting further doubt on a treatment plagued by years of failure
Boston Scientific's $27.5 billion Guidant buyout saddled the Massachusetts device giant with millions in pending product-liability lawsuits, and now the company has agreed to fork over $30 million to settle the last claims tied to two recalled defibrillators.
U.K. regulators have decided it is best after all if Indian drugmaker Wockhardt recalls a handful of drugs manufactured at its Chikalthana facility--earlier this week, the agency banned the company from exporting most of its drugs to Europe.
Another injected product is being recalled after particulate matter was discovered in a retained sample. This time, B. Braun Medical is voluntarily recalling one lot of an antibacterial infection treatment.
Shares of Amarin were blasted this morning--plunging 63%--as investors got a chance to vote with their money on the company's prospects following a decisive failure to persuade an FDA advisory committee that its fish-oil pill Vascepa should be approved for a much wider audience.
An FDA advisory panel is against extending the use of Amarin's fish-oil drug Vascepa with a cholesterol-lowering statin to reduce the risk of coronary disease; they are not convinced that doing so will prevent users from getting the potentially fatal disease.
Novo Nordisk is known for its dominance in the diabetes market. The company sports 5 of the 10 top-selling diabetes remedies worldwide. But the company has a stash of other treatments, and it just added one to the mix. The FDA gave its blessing to Novo's new factor VIII treatment for hemophilia A, NovoEight.