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.
Fast-Track Loss In EU For Celgene’s CAR-T Cell Therapy
Liso-cel Review Will Take Longer Than Anticipated in EU As Well As In US
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.
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Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.
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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
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Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.
Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry
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Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.
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Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.
• By
Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
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With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.