Feb. 28 (Bloomberg) --Gedeon Richter Nyrt. (RICHT) and Forest Laboratories Inc. (FRX) said that the experimental antipsychotic drug cariprazine met the goals of two late-stage clinical trials for the treatment of schizophrenia. The companies plan to seek approval for the drug this year to treat schizophrenia and bipolar mania, they said in a statement today. Budapest-based Richter [...]
As discussed in the New England Journal of Medicine on April 17, 2014 by Sarpatwari, Avorn, and Kesselheim, REMS are being used as a source of competitive advantage by some pharmaceutical companies. Researchers from the Brigham and Women's Hospital and Harvard Medical School published a Perspective in the New England Journal of Medicine (NEJM) describing possible [...]
Postmarketing Safety Data Drives Significant Value Even in the Absence of Identified Signals – Part 1 of 3
This is the first of a three part series on the value of disclosure of postmarketing safety information by pharmaceutical manufacturers. Spontaneous postmarketing safety data is typically kept confidential (there is no requirement for manufacturers to disclose data directly to the public) and only disclosed in a difficult to use format when a new [...]
Outsourcing is a part of our daily reality in the pharmaceutical industry. Both pharmacovigilance and medical affairs are utilizing outsourced resources to a greater and greater extent. Fiore Healthcare Advisors shares experience and perspectives on how to extract appropriate value from outsourcing. Please read our piece in Life Science Leader.
A double-edged reality of the digital age: most healthcare consumers get their drug safety information from the internet. Physicians and pharmacists must be prepared to address this issue. Google searches generally turn up Wikipedia as a top source, and a recent Perspective in the New England Journal of Medicine quantified exactly what that means [...]