Tags : Rejects

The US FDA Rejects Mallinckrodt’s Terlipressin Due to Doubts in

Shots: The US FDA has issued CRL to Terlipressin’s NDA for the treatment of hepatorenal syndrome type 1 (HRS-1) and requires more information to support a positive risk-benefit profile for the therapy in HRS-1 patients The company is confident with its P-III CONFIRM study assessing the safety and efficacy of terlipressin in patients with HRS-1 […]Read More

The US FDA Rejects Gilead’s Filgotinib Due to Toxicity Issues

Shots: The US FDA has issued a complete response letter for the NDA of filgotinib to treat moderately to severely active RA. FDA has requested data from two ongoing clinical trials, MANTA and MANTA-Ray assessing the effect of filgotinib (200mg) on sperm parameter The authority has expressed concerns regarding the overall benefit/risk profile of the […]Read More

NICE, UK Rejects Gilead’s Yescarta for Being Too Expensive

Shots: NICE concludes that the ICER Yescarta vs salvage CT were above £50,000 per year making it expensive for use  NICE also added considering ultra-orphan diseases that ICER for Yescarta was over £100,000 per QALY (Quality Adjusted Life)  Consideration of making Yescarta available via Cancer Drug Funds has also been dropped by the committee. Consultation […]Read More