(3rd September, 2014); The new agent, an angiotensin receptor-neprilysin inhibitor (ARNI) known as LCZ696, has already been granted Fast Track status by the United States Food and Drug Administration (FDA) – a designation which can expedite the review of new medicines intended to treat serious or life-threatening conditions. And surprisingly, LCZ696 was superior to ACE-inhibitor, enalapril, on key endpoints in the largest heart failure study ever done.
Initial human testing of an investigational vaccine to prevent Ebola virus disease will begin soon by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
(2nd September, 2014); Wockhardt Ltd’s New Drug Discovery program in Anti - Infective research received a major boost after two of its drugs, WCK 771 and WCK 2349, received the coveted Qualified Infectious Disease Product (QIDP) status from the US FDA. This is the first instance of an Indian Pharmaceutical company receiving a QIDP status.
(2nd September, 2014; Business Wire India); Five years on from the first breakthrough presentation of the pivotal RE-LY® clinical trial of Pradaxa® (dabigatran etexilate) for the prevention of stroke in non-valvular atrial fibrillation (NVAF), extensive clinical trial and real-world data support Pradaxa® in various indications. Boehringer Ingelheim continues to grow the evidence base for Pradaxa® to improve care for patients at risk of blood clots and today announces the initiation of Phase III of the GLORIA™-AF registry program in North America and in Europe. During this final phase of the registry program, data on the overall safety and effectiveness of antithrombotic treatments will be collected.
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