The Role Of RiskMAPs: Fentora Shows Shift From Post-Market To Pre-Market

Cephalon needs to improve the risk management plan for its breakthrough cancer pain drug Fentora regardless of whether it expands use to non-cancer pain patients, according to FDA and a joint Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committee

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EU Shaping Biotech Act To Unleash SME Potential

 

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
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Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.