Monday, September 2, 2013
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, EMA and Japan's
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
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.