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Category Archive for: ‘Drug news’

  • New restrictions on hydrocodone

    The federal government has issued a final rule imposing new restrictions on hydrocodone combination products (HCPs). Effective October 6th, 2014, hydrocodone-based products will be re-categorized as Schedule II drugs under the Controlled Substances Act. This higher drug classification includes highly controlled substances such as opioid …

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  • Games Drug Companies Play to Keep Drug Prices High

    Just recently, we ran across two new examples of pharmaceutical manufacturers acting counter to the interests of patients and payers.  In one case, the manufacturer of a drug losing patent protection next year decided to turn off supply of the patented drug in order to …

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  • The openFDA initiative: a new usage standard for health care data

    On June 2, 2014, the Food and Drug Administration (FDA) launched a publicly searchable, interactive database that allows health care stakeholders easy access to the FDA’s public data. This access will include updated drug product labeling for close to 60,000 prescription and over-the-counter drugs, recall …

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  • Concerns grow around new antibiotic bill and its effect on patient outcomes

    The Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) (H.R. 3742)was introduced by a bipartisan group of representatives on December 12th, 2013. The purpose of the Act is to advance drug development in order to combat the serious and growing public health …

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  • The MODDERN Cures Act – Part 1

    In September 2013, U.S. Representative Leonard Lance (R-NJ) introduced the MODDERN Cures Act (Modernizing Our Drug and Diagnostics Evaluation and Regulatory Network Cures Act of 2013 – H.R. 3116). In a strong show of bipartisan support, this bill recently had 64 co-sponsors who span both …

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  • Sovaldi: A Poster Child for Predatory Pricing

    In a previous post, we discussed how patients with chronic Hepatitis C virus (HCV) infections will benefit from Sovaldi (sofosbuvir) – one of a new class of blockbuster HCV drugs. It was reported that 95% of patients were cured by this drug during a 12-week …

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  • The High Cost of “Buy and Bill” in Cancer Treatment and Reasonable Solutions

    In 2013, approximately 14.5 million Americans were either recently diagnosed with cancer, being treated for cancer, or a cancer survivor. That part of the population over 65 accounted for 52.8% of new diagnoses even though they only made up 13% of the total U.S. population. …

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  • Developments and Spending Trends in Biologic Drugs

    Compared to traditional drugs synthesized from chemical processes, biologics are derived from living, biological sources such as humans, animals or microorganisms. Biologics are large molecules like proteins and monoclonal antibodies rather than small molecule lab-synthesized drugs. These drugs have wide applications in cancer, cardiovascular and …

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  • New EU report addresses inefficiencies in drug storage, transport and distribution

    Drug storage and distribution involves a complex network of systems, especially when it comes to moving medicinal products across international borders. Maintaining the integrity, safety and legitimacy of the process is a challenging task and one which involves compliance along the entire pharmaceutical supply chain. …

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  • Biosimilars Delay Causing Billions in Wasteful, Unnecessary Drug Spending

    A recent Wall Street Journal article, “Drug Delays Cost US Healthcare Payers Millions of Dollars,” got us thinking about wasteful and inefficient health care spending, including on prescription drugs.  Estimates vary, but a wide range of experts – including those from Dartmouth University, McKinsey, and …

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