In a deal that brings new assets to its Specialty Care division, Pfizer will acquire FoldRx Pharmaceuticals, focused on protein-misfolding diseases, for an undisclosed upfront payment and earnouts. FoldRx’s lead program, filed for approval at the European Medicines Agency in July, is tafamadis for the rare condition TTR amyloid polyneuropathy.
If Sanofi-Aventis acquires Genzyme as it hopes to, the French drug maker could soon emerge as an orphan drug leader. Orphan drugs are a different business model than the one big pharmas are built on, so it's a risky play for Sanofi since it's still unclear if big pharmas have what it takes to navigate the development and commercial intricacies of the orphan drug space.
Novo Nordisk is considering legal action against a number of wholesalers who appear to be spreading allegations that the company is unable to maintain the supply of its products. Novo Nordisk says that the wholesalers are creating the problem as a result of the company’s amendments to its business and sales conditions.
Increased mortality rate in an off-label use causes FDA to update the label for antibiotic Tygacil.
Allergan agrees to pay the government $600 million to resolve an investigation of its Botox sales and marketing practices. As part of the settlement the company is dropping its suit against FDA in which it claimed agency restrictions on off-label promotion violated the First Amendment.
