Roche and FDA in Oncology: Fighting in Public, Collaboarting in Private
This article was originally published in RPM Report
You may also be interested in...
Genentech’s Cancer Product Line Expands, As Do Its Post-Market Manufacturing Obligations
Genentech appears to be having significant manufacturing problems for some of its new cancer therapies. FDA hasn’t taken enforcement action yet, but the agency has delayed two approvals and tied them to post-market requirements to address QC issues.
Synchronized Regulation: Tandem Approvals Of Xalkori, Diagnostic Required Considerable Coordination
Pfizer’s Xalkori may be a model for fast development of a targeted oncologic and companion diagnostic, but that model is likely to be more aspiration than reality for future drug/diagnostic combinations. Extensive co-operation was required to keep two sponsors and two review centers on the same page – an effort that reflected the drug’s highly promising efficacy in early studies and FDA’s confidence that confirmatory studies would back up an accelerated approval.
Coverage With Evidence Development and Expedited Approvals: Policy Proposals For FDA and CMS
Based on stakeholder consultations, former FDA and CMS head Mark McClellan and former CMS official Sean Tunis present a potential upside for biopharma in broader use of Medicare coverage with evidence development. Pfizer executives participate in workshop on coordinating expedited drug approval, CED policies.