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Latest From Novartis AG

Sickle Cell Innovators Required: Emmaus' Pending Approval Highlights Rare Disease Void

FDA approval is likely for Emmaus' sickle cell drug L-glutamine this summer, representing the first new product for the disease since 1998 – a decision FDA advisory committee panelists hope will spur more innovation.

Approvals Research and Development Strategies

Appointments: IFPMA, Merck, Chromocell, Kymab, GW Pharmaceuticals, Fortuna Fix and Motif

This week's roundup includes high level appointments by Merck KGaA, Chromocell Corporation, Kymab and GW Pharmaceuticals, in addition to board appointments by Fortuna Fix and Motif Bio.

Appointments BioPharmaceutical

Keytruda Approval Opens New Routes For Immuno-Oncology

Merck's PD-1 inhibitor holds the first cancer indication based on biomarkers rather than tumor location. The most significant market will be colorectal cancer, but Bristol-Myers Squibb's Opdivo is pending for the same subgroup and Roche's Tecentriq could eventually gain a broader approval.

Approvals Drug Approval Standards

Biomarker Is King In Latest US FDA Cancer Drug Approval

Accelerated approval for patients with microsatellite instability-high or mismatch repair deficient solid tumors is the first time the US regulatory agency has granted an indication that does not specify the location of the tumor – a change that precision-medicine researchers have been eager to make.

Approvals Innovation
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