US Approves “New Class” of Diabetes Drug, Under Review in Canada.

US approves “new class” of diabetes drug, under review in Canada.

CMAJ. 2013 Jun 3;
Lange-Chenier H

HubMed – drug


Medicare Covers The Majority Of FDA-Approved Devices And Part B Drugs, But Restrictions And Discrepancies Remain.

Health Aff (Millwood). 2013 Jun; 32(6): 1109-15
Chambers JD, May KE, Neumann PJ

The Food and Drug Administration (FDA) and Medicare use different standards to determine, first, whether a new drug or medical device can be marketed to the public and, second, if the federal health insurance program will pay for use of the drug or device. This discrepancy creates hurdles and uncertainty for drug and device manufacturers. We analyzed discrepancies between FDA approval and Medicare national coverage determinations for sixty-nine devices and Part B drugs approved during 1999-2011. We found that Medicare covered FDA-approved drugs or devices 80 percent of the time. However, Medicare often added conditions beyond FDA approval, particularly for devices and most often restricting coverage to patients with the most severe disease. In some instances, Medicare was less restrictive than the FDA. Our findings highlight the importance for drug and device makers of anticipating Medicare’s needs when conducting clinical studies to support their products. Our findings also provide important insights for the FDA’s and Medicare’s pilot parallel review program. HubMed – drug


AIDS drug assistance programs: managers confront uncertainty and need to adapt as the affordable care act kicks in.

Health Aff (Millwood). 2013 Jun; 32(6): 1063-71
Martin EG, Meehan T, Schackman BR

With the Affordable Care Act set to expand insurance coverage to millions more Americans next year, existing discretionary health programs that receive federal support might find themselves competing for funds as the health reform law is fully implemented. To assess the implications the Affordable Care Act might have for discretionary health programs, we focused on state AIDS Drug Assistance Programs, which provide free medications to low-income HIV patients. We conducted semistructured interviews with program managers from twenty-two states. Many of the managers predicted that their programs will change focus to provide “wrap-around services,” such as helping newly insured clients finance out-of-pocket expenses, including copayments, deductibles, and premiums. Although program managers acknowledged that they must adapt to a changing environment, many said that they were overwhelmed by the complexity of the Affordable Care Act, and some expressed fear that state AIDS Drug Assistance Programs would be eliminated entirely. To remain viable, such programs must identify and justify the need for services in the context of the Affordable Care Act and receive sufficient political support and funding. HubMed – drug


Small molecule inhibitors of trans-translation have broad-spectrum antibiotic activity.

Proc Natl Acad Sci U S A. 2013 Jun 3;
Ramadoss NS, Alumasa JN, Cheng L, Wang Y, Li S, Chambers BS, Chang H, Chatterjee AK, Brinker A, Engels IH, Keiler KC

The trans-translation pathway for protein tagging and ribosome release plays a critical role for viability and virulence in a wide range of pathogens but is not found in animals. To explore the use of trans-translation as a target for antibiotic development, a high-throughput screen and secondary screening assays were used to identify small molecule inhibitors of the pathway. Compounds that inhibited protein tagging and proteolysis of tagged proteins were recovered from the screen. One of the most active compounds, KKL-35, inhibited the trans-translation tagging reaction with an IC50 = 0.9 µM. KKL-35 and other compounds identified in the screen exhibited broad-spectrum antibiotic activity, validating trans-translation as a target for drug development. This unique target could play a key role in combating strains of pathogenic bacteria that are resistant to existing antibiotics. HubMed – drug