Fast-Track Loss In EU For Celgene’s CAR-T Cell Therapy
Source : 'The Pink Sheet'
The review of liso-cel, Celgene/Bristol Myers Squibb's potential new CAR T-cell therapy for R/R DLBCL, is facing regulatory setbacks in the EU as well as in the US.
Celgene’s investigational CAR...
Rare Liver Disease Drug Contenders Among Latest EU Filings
Source : 'The Pink Sheet'
Among the 13 new drug marketing applications that the European Medicines Agency has most recently accepted for review are two products that could become the first approved treatments for children...
Monoclonal Antibodies For COVID Suffer Access Problems Due To Limited Infusion Reimbursement
Source : 'The Pink Sheet'
Unused supply for the Lilly and Regeneron therapies has policymakers considering Medicare payment changes for providers managing outpatient infusion, but those may require legislation. National Academies of Sciences, Engineering and...
Moderna’s Stronger Vaccine AdComm Vote Indicative Of Second Mover Advantage, Not Data Profile
Source : 'The Pink Sheet'
Moderna’s COVID-19 vaccine got a more solid ‘yes’ vote than Pfizer/BioNTech’s, but committee chair cautions against drawing any comparisons between the products from the different tallies. Last-minute bickering over FDA’s...