August 28th, 2014
Predicting PARADIGM-HF, or What to Expect When You’re Expecting
Larry Husten, PHD
Larry Husten analyzes the expectations surrounding the upcoming release of PARADIGM-HF and its centerpiece LCZ696 from the perspective of the medical field as well as the world of economics.
March 31st, 2014
Novartis Trial Was Stopped Early Because of a Significant Drop in Cardiovascular Mortality
Larry Husten, PHD
The largest-ever trial in heart failure was stopped early because of a highly statistically significant reduction in cardiovascular mortality, according to one of the trial’s two primary investigators. Earlier today I reported that the PARADIGM-HF trial testing LCZ696, a novel, first-in-class Angiotensin Receptor Neprilysin Inhibitor (ARNI), had been stopped early because the trial had demonstrated a significant reduction in the combined […]
March 31st, 2014
Early Success for Novel Novartis Heart Failure Drug
Larry Husten, PHD
A large clinical trial testing a novel compound from Novartis for chronic heart failure has been stopped early for efficacy. In a press release Novartis said the Data Monitoring Committee had recommended early closure of the PARADIGM-HF trial because the trial had demonstrated a significant reduction in the combined primary endpoint of cardiovascular death and heart failure hospitalization. PARADIGM-HF randomized patients with heart failure […]
September 27th, 2013
Saying Sorry May Not Be Good Enough for Novartis
Larry Husten, PHD
Novartis has issued a formal apology over misconduct relating to valsartan (Diovan) research in Japan, but that apology does not appear likely to satisfy the Japanese Health, Labor and Welfare Ministry, which plans to fully investigate the company’s role in the scandal. If necessary, ministry officials are prepared to raid the company’s offices in Japan. A Novartis official apologized to […]
July 30th, 2013
More Bad News for Valsartan
Larry Husten, PHD
In the last few days, more bad news about valsartan (Diovan, Novartis) has emerged. 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 drug […]