Settlement reflects existing landscape in which companies are avoiding no-authorized generic commitments, and may harbinger FTC's shift to other issues.

Final guidance notes that preliminary clinical evidence may come from studies conducted outside the US, says historical controls may be considered in clinical trial designs.

Global settlement resolves charges against Teva in three pending FTC antitrust suits and expands terms of 2015 consent decree.

Justice Sotoymayor suggests 'the deck is stacked' against private citizen who is dragged by government into AIA's post-grant review proceedings. Court denies petition seeking to revive Maryland's anti-price gouging law.

Final guidance notes that preliminary clinical evidence may come from studies conducted outside the US, says historical controls may be considered in clinical trial designs.

Melinta describes difficulties launching its new antibiotics at BIO CEO & Investor Conference; companies and other stakeholders urge Congress to enact package of incentives to reinvigorate antibiotic pipeline.