This article was originally published in Pharmaceutical Approvals Monthly
The African American Heart Failure Trial (A-HeFT), the first prospective trial conducted exclusively in black men and women with heart failure, begins. The double-blind, placebo-controlled study is randomizing patients to receive BiDil (hydralazine HCl and isosorbide) or placebo in addition to their standard therapy (ACE inhibitors, digitalis, diuretics and beta-blockers). The study, initiated March 17, will enroll 600 patients with moderate to severe heart failure and a reduced ejection fraction who had at least one hospitalization for heart failure in the preceding 12 months. NitroMed submitted a BiDil NDA for treatment of heart failure in African Americans in July 200
You may also be interested in...
Cosmetics Europe Talks Microplastic: ECHA Frustrations, ‘Value Judgments’ And International Trade Uncertainty
The European Chemicals Agency's microplastic restriction proposal received committee backing in 2020 without changes sought by the cosmetics industry, which faces €15bn in projected costs and scarce alternatives at present. It may come down to EU Member States to decide whether the ECHA restriction proposal is proportionate in balancing environmental goals and socio-economic impacts.
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.