Roche Holding AG, Johnson & Johnson and Biogen Idec Inc. are being urged by U.S. regulator to see if presented medicines may help neglected disorders, after an incentive plan failed to spark research on new therapies.The Food and Drug Administration is publishing a list of 235 treatments today that may have benefit in unusual disorders and already have marketing clearance for other uses.
Identifying “low-hanging fruit” may compel large drugmakers to look beyond common ailments with guaranteed consumer require, said Tim Cote, head of the agency’s Office of Orphan Product Development.The list includes Roche’s hepatitis drug Pegasys, J&J’s leukemia medicine Leustatin and Biogen Idec’s several sclerosis drug Avonex. Regulators need new tactics since an research two years ago to give priority review vouchers in exchange for new drugs for steamy diseases drew only one participant.
“Large pharmaceutical companies are not as hard as we’d like to see them be,” Cote said in a phone interview. “I myself have knock on the doors of all the big boys.”About 30 million Americans have one of 7,000 rare diseases, define by the FDA as conditions alarming fewer than 200,000 people in the U.S. Medicines developed to treat these situation are called orphan drugs, under policy that encourage their growth.
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Identifying “low-hanging fruit” may compel large drugmakers to look beyond common ailments with guaranteed consumer require, said Tim Cote, head of the agency’s Office of Orphan Product Development.The list includes Roche’s hepatitis drug Pegasys, J&J’s leukemia medicine Leustatin and Biogen Idec’s several sclerosis drug Avonex. Regulators need new tactics since an research two years ago to give priority review vouchers in exchange for new drugs for steamy diseases drew only one participant.
“Large pharmaceutical companies are not as hard as we’d like to see them be,” Cote said in a phone interview. “I myself have knock on the doors of all the big boys.”About 30 million Americans have one of 7,000 rare diseases, define by the FDA as conditions alarming fewer than 200,000 people in the U.S. Medicines developed to treat these situation are called orphan drugs, under policy that encourage their growth.
useful links: transport rankings
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