Franchise Management Likely To Be Theme Of 2015 Oncology Approvals
Lung cancer will be a battleground in 2015, as the big pharma oncology players jockey for position in immuno-oncology while filling out their targeted therapy portfolios.
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Genentech Catching Up In Melanoma With Cotellic Approval
FDA clears Cotellic/Zelboraf combination, but the company already is testing the addition of a PD-L1 inhibitor.
FDA Starts 2015 As It Plans To Go On: A Spate Of Approvals, A Full Slate Of Possibilities
With more than 40 novel agents under FDA review – and six approvals already – prospects are good for 2015 to be another stellar year for new molecular entity and novel biologic approvals. Supplemental indications with “breakthrough” designations and the first biosimilars could challenge the primacy of NMEs in the approval narrative.
Immunotherapy: Big Pharma’s Seductive Embrace
The oncology community believes that immunotherapy will be foundational, in the same way that combination chemotherapy became the backbone of treatment in the 1970s. The marching order is to trial broadly, quickly, making clinical development particularly well-suited for Big Pharma.