publication date: Sep. 11, 2015
What’s in a Suffix?
FDA’s Dilemma: How to Name Biologics
After a courtroom victory against Amgen Inc. this summer, the last of the obstacles was removed for the first biosimilar agent—a white blood cell growth factor—to enter the U.S. market.
Zarxio (filgrastim-sndz), sponsored by Sandoz Pharmaceuticals, a unit of Novartis, appeared on the U.S. market Sept. 3, offering a lower-priced alternative to the branded product, Neupogen.
With biosimilars about to appear on the market, FDA is preparing to reconsider the manner in which these agents—as well as the reference products they copy—are named.
 | HRSA Publishes Long-Awaited 340B Mega-Rule The Health Resources and Services Administration issued the long-awaited “mega-rule” intended to define who qualifies for deep discounts on drug prices under the federal 340B program. Established in 1992 to benefit hospitals and clinics that serve low-income and uninsured patients, the 340B Drug Pricing Program has expanded exponentially in recent years. |
| GAO to Investigate Power Morcellation Harms The U.S. Government Accountability Office said it would investigate the controversy stemming from wide use of power morcellators, gynecological devices now known to spread undetected cancers during hysterectomies and myomectomies. The GAO’s Sept. 4 move comes after 12 members of Congress wrote a letter requesting an investigation. |
| Obituary Gianni Bonadonna, 81, Pioneering Researcher Gianni Bonadonna, 81, a pioneering cancer researcher whose work focused on Hodgkin’s lymphoma and breast cancer, died Sept. 7. His death was announced by the Istituto Nazionale Tumori of Milan. Bonadonna research included the initial studies on the clinical efficacy of adriamycin (doxorubicin), epirubicin and bleomycin; a number of seminal trials on adjuvant and primary chemotherapy for high-risk breast cancer; as well as a combined modality for the treatment of Hodgkin’s disease—in 1972, he designed a new combination of drugs known as ABVD: adriamycin, bleomycin, vinblastine and dacarbazine. |
| CVS Marks First Anniversary Of Stopping Tobacco Sales CVS Health marked the first anniversary of ending tobacco sales at its CVS/pharmacy locations, and released study data showing a reduction in cigarette purchases over the past year. The company also announced a joint initiative between CVS Health and Scholastic to launch a school-based tobacco-prevention program. |
| 70th Annual Lasker Awards Go To Witkin, Elledge, Allison, Medecins Sans Frontieres The 70th annual Lasker Awards went to: Evelyn Witkin and Stephen Elledge for basic medical research; James Allison for clinical research; and Medecins Sans Frontieres for public service. The awards carry an honorarium of $250,000 for each category, and will be presented Sept. 18 in New York City. |
| In Brief |
| Drugs and TargetsFDA grants Priority Review to Alectinib in lung cancer - Janssen and Alligator Bioscience enter agreement
Sequenom to collaborate with UC San Diego - Vaccinogen enters agreement with Dublin City University over DiCAST
OICR and Structural Genomics Consortium make drug prototype available to the research community - PhRMA publishes report on U.S. drugs in development
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