Teva Pay-For-Delay Plausible; Judge Finds Payments Exceed Litigation Costs

While the government announces eight to 15% cuts to the four products, industry groups urges for its operational improvement without expansion.

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

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.