FHA Perspectives

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Forest, Richter Schizophrenia Drug Met Clinical Trial Goals

By |2019-09-22T04:04:47+00:00July 2nd, 2015|

Forest, Richter Schizophrenia Drug Met Clinical Trial Goals 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, [...]

Beyond Competitive Advantage – Who should be trusted to distribute a product requiring a REMS?

By |2019-09-22T03:57:51+00:00July 2nd, 2015|

Beyond Competitive Advantage - Who should be trusted to distribute a product requiring a REMS? 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 [...]

Postmarketing Safety Data Drives Significant Value Even in the Absence of Identified Signals – Part 1 of 3

By |2019-10-19T01:35:40+00:00July 2nd, 2015|

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 [...]

Outsourcing Best Practices

By |2019-10-06T02:28:52+00:00July 2nd, 2015|

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.

Guide to surviving the digital age as consumers obtain safety information online

By |2019-10-19T00:12:22+00:00July 2nd, 2015|

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 [...]