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    UK’s NIBSC Updates on No-Deal Brexit Plans

    With less than a month remaining before the UK exits the EU, the UK’s National Institute for Biological Standards and Control (NIBSC) on Thursday provided an update in the event of a no-deal Brexit scenario.   In the update, the NIBSC, which produces and distributes a wide range of biological reference materials and functions as the UK’s official medicines control laboratory for biological products, says that while a Brexit deal “remains the Government’s top priority”...
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    Who's Actually Using 'Right-To-Try' Laws? A Texas Oncologist Explains his Experience

    What do a former prosecutor living in Arizona and unexpectedly diagnosed with neuroendocrine tumors by a specialist at the Mayo Clinic and referred for treatment in Switzerland, a Coloradoan who was also diagnosed and referred to Switzerland for treatment, and a Los Angeles-based lawyer who tried to get into immunotherapy trials but was denied have in common? They all say they obtained treatment from a Houston-based oncology center that has extended their lives than...
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    FDA, NCI to Collaborate Further on Cancer Research

    The US Food and Drug Administration (FDA) and National Cancer Institute (NCI) on Monday unveiled a memorandum of understanding (MOU) to further cooperate on understanding the molecular biology of cancer as it relates to diagnostic measurements, product development and treatment. "The purpose of this MOU is to engage in scientific and programmatic collaborations in clinical proteogenomics cancer research, such as statistical experimental design, instrument/technolo...
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    Senate Committee Takes First Step on Rising Pharmaceutical Prices

    The US Senate Health, Education, Labor and Pensions Committee held the first of three hearings on rising pharmaceutical prices Tuesday, discussing the confusing system by which prices are set and possible ways to bring them down. Sen. Lamar Alexander (R-TN) opened the hearing by highlighting the extent to which biopharmaceutical companies pay for the development of new medicines, and to note there will be two more hearings focused on R&D and supply chain expenses, ...
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    NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs

    The National Cancer Institute (NCI) on Wednesday launched a new effort under the cancer "Moonshot" initiative to speed access to approved and investigational drugs for use in preclinical and clinical cancer studies. The effort, referred to as the NCI Formulary, is intended to streamline the negotiation process between investigators at NCI-designated cancer centers and participating pharmaceutical companies. "As genomic sequencing data become mainstream in cancer therapy...
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    FDA Official Dispels ‘100 Hours’ Myth on Time it Takes to Fill Out Compassionate Use Form

    The simplification of the US Food and Drug Administration’s (FDA) compassionate use process (announced last February and expected to be finalized very soon) may not actually be all that much of a simplification in terms of the amount of time it takes a physician to fill out the form, an FDA official told Focus on Tuesday. Richard Klein, director of the Patient Liaison Program in FDA’s Office of Health and Constituent Affairs, explained to Focus , following Monday’s ...
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    New Bill Would Speed FDA Review of OTC Contraceptives

    Editor's note: This article has been updated to clarify that the Oregon bill allows pharmacists to prescribe certain contraceptive drugs to patients. A new House bill, sponsored by Rep. Mia Love (R-UT), would speed the review of contraceptive drugs by the US Food and Drug Administration (FDA), and includes measures to make the drugs available over-the-counter for adult women. The bill, known as the Over-The-Counter Contraceptives Act , would compel FDA to grant suppl...
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    Group Sues FDA, Seeking Access to Ebola Information

    A battle over regulatory documents has led a libertarian-leaning think tank, The Goldwater Institute, to sue the US Food and Drug Administration (FDA) in the hopes of compelling the agency to hand over information related to how several US citizens received drugs to treat the Ebola virus. Background In August 2014, the American public became fixated on an outbreak of Ebola in West Africa after two US missionaries, Dr. Kent Brantley and Nancy Writebol, became infected wi...
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    Breaking Bottlenecks: FDA Clarifies Tool for Expediting Drug Development (Corrected)

    The US Food and Drug Administration (FDA) is trying to clarify how industry can request a meeting of the agency's Critical Path Initiative (CPI), a decade-old effort to accelerate drug development through the use of common standards. Correction: A previous iteration of this article suggested that FDA's effort under the Critical Path Initiative, as well as its Critical Path Innovation Meetings (CPIM), were connected with the Critical Path Institute (C-Path)—a public-priv...
  • Report Finds Huge Variations in CDER Performance, but Few Explanations as to Why

    New research published by the Manhattan Institute for Policy Research (MIPR), a right-leaning think tank which focuses in part on pharmaceutical regulation policy, indicates that there are wide gaps in performance among the US Food and Drug Administration's (FDA) review divisions, resulting in a "productivity gap" that has left some patients without ready access to new therapies. Background MIPR's research report, An FDA Report Card: Wide Performance Found Among Agenc...
  • Report: Phase III Clinical Trials Behind Increase in the Cost of Pharmaceuticals

    The US Food and Drug Administration's (FDA) insistence that pharmaceutical manufacturers take their products through extensive-and expensive-testing is driving up the price of drugs and the stakes of failure for companies. That's the conclusion of a new paper from Avik S.A. Roy, a senior fellow at the Manhattan Institute for Policy Research, entitled "Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials."  Roy cites the dramatic rise in the cost to res...
  • C-Path Initiative's Work on Personalized Medicine Starts to Get Results

    The Critical path Institute (C-Path), the US Food and Drug Administration (FDA)-supported public-private initiative working to advance personalized medicine, is advancing quickly and is bearing results, reports The Arizona Star . C-Path, now under the leadership of President and CEO Dr. Carolyn Compton, is working with numerous private companies to create technologies to develop safer, more effective drugs. "The idea here is, through the creation of new tools, new meas...