The pharma giant announced that the data monitoring committee has hit the green light for any early close to the pivotal study for its new blood pressure treatment LCZ696 after investigators tracked delays in cardiovascular deaths and fewer hospitalizations resulting from heart failure in comparison to Vasotec, a generic blood pressure medicine that has been around for years.
In an effort to get itself into a place where it can again ship from its FDA-approved plants in India, Ranbaxy Laboratories says it is taking a hard look at how it runs its API operations.
Novartis' productivity program saved the company $2.8 billion last year, CEO Joe Jimenez said Wednesday as he discussed the company's tepid fourth quarter and 2013 financial results. The most recent target for manufacturing cuts, he said, is a plant in Suffern, NY, which produces Diovan for the U.S.
2014 looks to be another year of transition for Novartis. It now expects the long-delayed U.S. release of a generic of its blockbuster Diovan to happen in the second quarter and by summer's end hopes to have completed the strategic review that will decide the fate of several of its operating units.
Novartis' blockbuster Diovan has enjoyed nearly 18 months of sales unscathed by generics since its patent expired in September 2012, as regulatory entanglements have kept Ranbaxy Laboratories from producing its copycat version. Now the Indian drugmaker has a plan to finally get it to market and claim its 6 months of exclusivity.
Among all of the fallout from the well-publicized manufacturing mess at Ranbaxy Laboratories has been its inability to get a generic of Novartis' blockbuster hypertension fighter Diovan to market. Reports have now surfaced that indicate the Indian drugmaker wants to make the drug in the U.S., using an API supplied by another company.
The Diovan data scandal in Japan has spawned a criminal action against Novartis. The country's Health Ministry lodged a complaint against Novartis today, accusing its domestic unit of exaggerated advertising.
Japanese officials say they are preparing to prosecute Novartis for false advertising after two universities found falsified data in a disputed Diovan study, The Japan Times reports.
Today, Novartis had the pleasure of hiking its 2013 forecast for the second time this year. And once again, it has Diovan to thank--or, to put a finer point on it, Novartis has Ranbaxy Laboratories to thank. The ongoing bumbling at the Indian generics maker means there's still no copycat version of Diovan to drain away sales of the blockbuster blood-pressure drug.
Novartis pharma chief David Epstein isn't worried about Japanese sales of the blood pressure drug Diovan. He's "much more worried" about the Swiss drugmaker's reputation, now that its Diovan marketing and research are under investigation in Japan. And top-level Novartis managers in Japan are already feeling the effects of that concern.