With the US solicitor general offering support for Teva over GSK in long-running litigation over skinny-label carve-outs of generic indications, the stage could be set for a major reversal at the Supreme Court that would favor the generics industry.
Teva has seen its chances of success in a long-running US legal battle over “skinny-label” generics given a major boost, after the US solicitor general emphatically supported the firm’s position as it seeks a Supreme Court review of litigation over induced-infringement claims made by GlaxoSmithKline.
The case – which holds wider significance for all generics that carve out patented indications under the US “section viii”...
As Alvotech announced first-half results that outpaced expectations, the biosimilars developer’s management explained that the firm was targeting value and product margin over market share and volumes.
Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.
