Back to School 2013: Facing reality

For the first time since the 2008 meltdown, nearly everything appears to be coming up roses for biopharma. Money is again flowing into the sector, FDA, EMAand Japan's Pharmaceuticals and Medical Devices Agency are reporting rising numbers of approvals, and new regulatory pathways promise to increase the speed of development and approval of drugs that could provide treatment breakthroughs for patients who are gravely ill.

But just as regulators and companies attempt to speed highly promising drugs to market based on abbreviated data packages, payers worldwide are making reimbursement contingent upon the kinds of data that can take years of postmarket experience to collect...