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First U.S. Biosimilar Can Enter Market Sept. 3; Court Denies Amgen’s Motion To Block Zarxio

The first FDA-approved biosimilar may enter the market as soon as Thursday (Sept. 3) due to a federal appeals court's denial of Amgen’s emergency motion to block Sandoz from marketing its biosimilar Zarxio.

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A coalition of physicians is using FDA's plan to give biosimilars distinct names to lobby against CMS' payment proposal for such products.

The brand-name pharmaceutical industry is pleased with certain changes the Health Resources and Services Administration made that some say could restrict the scope of patients eligible to be treated with discounted drugs under the 340B program, but drug makers say HRSA's newly issued guidance doesn't go far enough to resolve their concerns about 340B program integrity.

The Medical Group Management Association is calling on CMS to extend the 2015 meaningful use reporting period so that providers will have enough time to implement changes to the program once the final rule laying out these changes is released.

HHS released for public comment proposed revisions to the regulatory oversight of research involving human participants, with the updates reflecting the significant growth in technology, expansion of scientific research into new areas and increased number of sites at which individual studies are conducted.

Democratic presidential candidate Bernie Sanders (I-VT) said Tuesday (Sept. 1) he will introduce a measure to curb drug price hikes that includes nearly every Democratic proposal on the issue from past decades.

FDA is cracking down on powdered pure caffeine, which has been linked to two deaths in 2014, sending warning letters Tuesday (Sept. 1) to five dietary supplement distributors that sell the product, advising them that serving size information on their labels makes their products a safety risk.

IRS on Monday proposed a rule that requires employer plans to offer hospital and physician services in addition to hitting a 60 percent actuarial value order to meet the ACA's definition of a minimum value and thus avoid paying a fee under the employer mandate.

CMS unveiled Tuesday (Sept. 1) a Medicare Advantage Value-Based Insurance Design (MA-VBID) Model that lets plans tailor benefits as part of a bid to improve enrollees' health and in turn lower costs, such as by eliminating eye exam co-pays for diabetics or by providing extra tobacco-cessation assistance for enrollees with lung disease.