PHARMACEUTICALS
▸ NIH research contributed to all new U.S. drugs NIH-funded research was associated with all 210 new drugs approved by the FDA between 2010 and 2016, a contribution that totals over $100 billion, a new study claims. The paper by researchers at Bentley University found over 2 million publications in PubMed, NIH’s publication indexing service, related to the new molecular entities or their biological targets (Proc. Natl. Acad. Sci. USA 2018, DOI:10.1073/pnas.1715368115). Over 90% of that research was basic science related to the biological target of the drug. Previous estimates have suggested far lower contributions by NIH to new drug discovery. The authors say this is probably because publications are more likely to reflect basic research than patents or New Drug Applications. “Published research, taken as a whole, reflects the advancing forefront of knowledge from which new drugs are discovered and developed,” the paper says. The authors suggest the government contribution to the 84 first-in-class drugs approved could be as high as $839 million. Recent talk of funding cuts for NIH threaten the drug pipeline, the authors say. Any cuts are unlikely to be made up by private philanthropy or the biopharmaceutical sector, given its decreased investment in basic research.—ANDREA WIDENER
RADIOCHEMISTRY
New way to produce medical isotope wins U.S. approval U.S. regulators are giving the green light to a new technology to produce technetium-99m, the most widely used radioisotope for medical imaging, without relying on weapons-grade highly enriched uranium. Earlier this month, FDA approved the RadioGenix System, a product of NorthStar Medical Radioisotopes of Beloit, Wis. The technology involves conversion of molybdenum-98 via neutron bombardment or of 100Mo in a linear accelerator to 99Mo. Next, 99Mo is processed into a form that allows elution of 99mTc, its daughter radionuclide, according to the Nuclear Regulatory Commission. For more than a quarter century, U.S. supplies of 99mTc involved shipping enriched uranium out of the country for irradiation and then importing the resulting 99Mo, FDA Commissioner Scott Gottlieb says. The foreign facilities that performed the irradiation, he says, “were vulnerable to unforeseen shutdowns or closures.” The Nuclear Regulatory Commission is developing guidance for facilities using the RadioGenix system Technetium-99 is and will license the new technology so the 99mTc it the most common tracer used in produces may legally be used for medical purposes. 99mTc, which emits gamma rays, is used to detect corgamma camera scans. onary artery disease and cancer and to evaluate lung, liver, kidney, and brain function, FDA says. In 2016, the National Academy of Sciences warned about the potential for shortages of key medical isotopes derived from enriched uranium.—CHERYL HOGUE
PHARMACEUTICALS
C R E D I T: S H UT T E RSTO CK
▸ India, Pfizer tackling antimicrobial resistance The Indian Council of Medical Research and the pharmaceutical giant Pfizer are establishing a center in New Delhi to combat the growing threat of antimicrobial resistance. India has among the highest rates of antibiotic consumption and antimicrobial resistance in the world. Reasons for those rates include over-the-counter pharmacy sales and a market flooded with unregulated drugs. One recent study of Indian antibiotic sales data and regulatory records from 2007 to 2012 found that 64% of one class of antibiotic formulations had no record of regulatory approval (Br. J. Clin. Pharmacol. 2018, DOI: 10.1111/bcp.13503). People taking antibiotics for viral infections or antibiotics that don’t work for the microorganism causing the problem
“just helps to select out resistant bacteria that then spread around,” says Patricia McGettigan of Queen Mary University of London, the lead author of the study. Pfizer has provided an initial grant of about $1.09 million for the new center, which will focus on efforts such as scaling up an existing antimicrobial resistance surveillance network and creating awareness around responsible use of antibiotics.—K. V. VEN-
KATASUBRAMANIAN, special to C&EN
INTELLECTUAL PROPERTY
▸ U.S. Senate confirms patent office director The U.S. Senate unanimously approved President Donald J. Trump’s nominee to lead the U.S. Patent & Trademark Office. Lawmakers voted 94-0 on Feb. 5 to confirm
Andrei Iancu, a patent litigator at Irell & Manella, a Los Angeles-based intellectual property law firm. He will manage a staff of about 8,000 examiners who grant patent protection to more than 300,000 inventions each year. Iancu has represented both patent owners and accused infringers in various fields, including genetic testing, therapeutics, and computer hardware and software. “In an area fraught with allegiances to particular industries or groups, Andrei can bring a neutral, unbiased perspective because he’s already had to approach issues from so many different angles,” said Sen. Orrin Hatch (R-Utah) in remarks on the Senate floor. James C. Greenwood, president of the Biotechnology Innovation Organization, an industry trade group, says he looks forward to working with Iancu and his staff to “promote greater predictability and certainty of patent rights as a basis for investment in innovation.”—GLENN HESS, special to C&EN FEBRUARY 19, 2018 | CEN.ACS.ORG | C&EN
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