Clinical Trials, Corporate Transparency
Executive Summary
GlaxoSmithKline PLC settled a suit brought against it in June by New York State attorney general Eliot Spitzer, who had charged the company with hiding clinical trial data about its blockbuster antidepressant paroxetine (Paxil), but the pharmaceutical industry as a whole is experiencing repercussions. Now PhRMA advocates publishing all Phase III trials for approved drugs.
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Lilly's Transparency Strategy
Lilly sees its own credibility problem, and the industry's, as a major financial challenge--compromising approvals, marketing claims and pricing. It also contends its solution, providing far more information about its products through its marketing and R&D organizations, provides a solution for the industry as a whole. But as it's been rolled out so far, the strategy will disproportionately benefit Lilly.
Canary in the Coalmine: Pfizer R&D
In an interview, Pfizer's head of R&D, John LaMattina, discusses R&D's position as the part of the company most vulnerable to cuts in response to weakening sales. Among other issues, LaMattina discusses Pfizer's increasing interest in large molecules, specialist markets and combination products, and the role external research will play in filling a pipeline facing significant near-term generic pressures. He also details Pfizer's advantages of scale, particularly in developing portfolios of products in individual disease areas for sale to major customers interested in large discounted, disease-managed product packages.
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.