Obama extends program for rare pediatric drugs - C&EN Global

President Barack Obama has signed into law a bill ( S. 1878) extending FDA's rare pediatric disease priority review voucher program through the end of...
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PHARMACEUTICALS

▸ Obama extends program for rare pediatric drugs President Barack Obama has signed into law a bill (S. 1878) extending FDA’s rare pediatric disease priority review voucher program through the end of the year. The biotech industry, which strongly supports the program, is urging lawmakers to include a multiyear extension in the 21st Century Cures Act, a sweeping piece of health care legislation that is being negotiated by the House of Representatives and the Senate. The rare pediatric disease program awards a voucher to a drugmaker that wins approval of a treatment for an illness affecting 200,000 or fewer children. The company can later redeem the voucher when seeking approval for another medicine to treat any illness. FDA is obligated to review the other drug in six months instead of the standard 10 months. The Biotechnology Innovation Organization, an industry trade group, calls the voucher program “a critical incentive in promoting research into rare diseases affecting children.” But FDA has criticized the program, arguing the vouchers can delay reviews of more urgently needed medicines.—GLENN

HESS, special to C&EN

POLICY

CREDIT: SHUTTERSTOCK

▸ DOE science office advances chemist The Department of Energy has named computational chemist Steve Binkley deputy director of science programs in the Department of Energy’s Office of Science. Binkley, currently head of the department’s Office of Advanced Scientific Computing Research, received a doctorate in chemistry from Carnegie Mellon University in 1978. He previously worked for Sandia National Laboratories and the Department of Homeland Security. Binkley’s research interests include the properties of atoms and molecules, the simulation of complex systems, and the computer science of massively parallel computers and large-data systems. The deputy director of science programs oversees Office of Science grant-making program offices— Advanced Scientific Computing Research, Basic Energy Sciences, Biological & Environmental Research, Fusion Energy Sci-

PESTICIDES

U.K. butterfly population on the decline The U.K. witnessed its largest decline ever this year in the number of butterflies observed during its annual summer butterfly count. Data from the environmental group Butterfly Conservation show that more than half of the 20 butterfly species monitored in the U.K. have declined since last year, including the peacock butterfly shown here. The group says habitat destruction, climate change, and pesticides are all involved.—BRITT ERICKSON

ences, High Energy Physics, and Nuclear Physics—and reports to Office of Science Director Cherry Murray. It is the highest science-related Office of Science position that does not require Senate confirmation. Binkley is replacing chemical physicist Patricia M. Dehmer, who is retiring Nov. 10 after nine years in the job.—JESSICA

MORRISON

INTELLECTUAL PROPERTY

▸ Patent office upholds validity of Shire drug patent The U.S. Patent & Trademark Office (PTO) has handed hedge fund manager J. Kyle Bass’s Coalition for Affordable Drugs its first loss by upholding the validity of the patent covering Shire’s colitis drug Lialda.

Bass argued that the patent never should have been issued because it was based on science already in the public domain, but PTO’s appeals board rejected that position. The decision potentially protects Lialda from generics competition until 2020. The coalition has filed more than 30 petitions that seek to nullify what it sees as invalid drug patents. Later this month, the appeals board is expected to make decisions on a patent covering another Shire drug, Gattex, which treats short-bowel syndrome, and on Celgene’s blood cancer drug Revlimid. “We look forward to continuing our work of challenging dubious patents that enshrine monopolies protecting drugs that lack innovation to the detriment of Americans suffering from illness,” Bass says. The pharma sector has charged that Bass is abusing the patent review system as part of a short-selling strategy aimed at driving down the price of drug company stocks.—GLENN HESS,

special to C&EN OCTOBER 17, 2016 | CEN.ACS.ORG | C&EN

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