In the last few days more bad news about valsartan (Diovan, Novartis) has emerged in Japan. Another major study conducted in Japan– the Jikei Heart Study– will be retracted and Japanese health authorities said they were investigating severe skin reactions associated with use of the drug. The new events are only the latest problems for the…
Novel Heart Failure Drug From Novartis Gains ‘Breakthrough Therapy’ Designation From FDA
June 27, 2013 by 1 Comment
Serelaxin, the novel therapy under development for the treatment of acute heart failure, has received a “breakthrough therapy” designation from the FDA, according to Novartis, the company developing the drug. The designation, the FDA explains, “is intended to expedite the development and review of drugs for serious or life-threatening conditions” and requires “preliminary clinical evidence that demonstrates the…
Novartis Acknowledges Employees Participated In ‘Independent’ Trials
May 23, 2013 by Leave a Comment
Novartis has acknowledged that employees of the company participated in five “independent” investigator-initiated post-registration trials without disclosing their relationship to the company. The company said that a broader “comprehensive investigation with independent third party experts is ongoing” but that it has “provided an update” to Japanese medical societies and to the principal investigators of the five…
Another One Bites the Dust: Diovan Patent Expires But Generic Valsartan Is MIA
September 25, 2012 by 1 Comment
Although the patent on valsartan (Diovan, Novartis) expired last Friday, a generic version of the popular antihypertensive drug has yet to make it to market. By contrast, a generic version of Diovan HCT, the combination of valsartan and hydrochlorothiazide, was recently launched by generic drugmaker Mylan. As reported on Pharmalot, Ranbaxy, the embattled generic drugmaker, holds…
Novartis Announces Top Line Results For Phase 3 Trial Of New Acute Heart Failure Drug
September 24, 2012 by Leave a Comment
Novartis announced preliminary results from the RELAX-AHF trial, a phase 3 study of a novel drug, RLX030 (serelaxin), for patients hospitalized with acute heart failure. The company said the trial met one of its two primary endpoints in reducing dyspnea. Novartis also reported a reduction in all cause mortality at 6 months. However, it should be…
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