Elan to settle DoJ Zonegran investigation: Elan announced on July 15 that it has reached an agreement in principle with the U.S. Attorney's Office in Massachusetts to pay $203.5 million to settle an investigation of its sales and marketing practices for the antiepileptic Zonegran (zonisamide). The company said it expects to plead guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act and to enter into a corporate integrity agreement with the HHS Office of Inspector General. Eisai acquired Zonegran from Elan in 2004. In 2006, the OIG served Eisai and Elan with subpoenas requesting their marketing materials for the drug (1"The Pink Sheet," Feb. 6, 2006)

Eisai acquires Elan anti-epilepsy agent Zonegran (zonisamide) for $130 mil., plus up to $110 mil. in milestone payments. Eisai also will hire 100 of Elan's sales reps to market the product. Acquisition is part of Eisai's strategy to grow its neurological franchise and its presence in the U.S. Elan's divestiture is one of several used to raise cash ahead of key launches, including Antegren for multiple sclerosis and Crohn's disease in 2005 (1"The Pink Sheet" Feb. 23, 2004, p. 25)...

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.