Facing an appeal on a favorable US district court decision, Mylan has opted to launch “at risk” the first generic Tecfidera in the US, after obtaining FDA approval and seeing the originator’s bid for injunctive relief shot down earlier this month.
Mylan has decided to introduce “at risk” the first generic version of Biogen’s $3.3bn Tecfidera (dimethyl fumarate) in the US following US Food and Drug Administration approval for its abbreviated new drug application, with litigation still pending over the last remaining Tecfidera patent listed in the agency’s Orange Book.
Market entry was confirmed by Mylan today, hours after the FDA’s database of approved drugs showed the company as holding...
The first new drug for fibromyalgia since 2009, Tonmya is a reformulation of cyclobenzaprine intended for chronic therapy. Tonix said the drug targets non-restorative sleep.
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.
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.
