Study assesses copy number alterations and leukemia prognosis | Phase IIb trial evaluates HIV drug doravirine | Researchers place light-emitting proteins in immune cells
 
 
July 24, 2015
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Study assesses copy number alterations and leukemia prognosis
Copy number alterations are associated with adverse prognoses among patients with de novo precursor B-cell acute lymphoblastic leukemia, according to a study in the journal Cancer. Researchers analyzed copy number alterations in 12 regions in the 142-patient study. The most frequent alteration was CDKN2A/B, followed by IKZF1. CancerTherapyAdvisor.com (7/22)
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Science & Health
Phase IIb trial evaluates HIV drug doravirine
A 216-patient Phase IIb clinical trial found that response rates for a three-drug HIV regimen including doravirine were comparable to those of a regimen that included efavirenz. The rate of patients achieving viral loads below 200 copies/ml for the doravirine regimen was 88.9%, compared with 87.0% for efavirenz regimen. The study was presented at a meeting of the International AIDS Society. Aidsmap (7/23)
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Emerging Trends
Researchers place light-emitting proteins in immune cells
Scientists with the University of St. Andrews in Scotland reported in the journal Nano Letters that they have developed microresonators with light-emitting proteins small enough to be embedded in white blood cells. The protein can be excited by laser light, allowing researchers to track the cells. United Press International (7/23)
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Industry News & Practice
Amgen seeks FDA approval for expanded use of myeloma drug
A supplemental new drug application was filed by Amgen for the use of Kyprolis, or carfilzomib, combined with dexamethasone to treat relapsed multiple myeloma patients given at least one previous treatment. The application was backed by trial data showing the Kyprolis and dexamethasone combination prolonged patients' progression-free survival better than bortezomib. OncLive (7/23), European Pharmaceutical Review (U.K.) (7/23)
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Developer of drug for rare blood disease receives $58.5 million
A Series B funding round has pulled in $58.5 million for Cambridge, Mass.-based Ra Pharmaceuticals. The firm intends to use the money to support the development of RA101495 as a treatment for the blood disorder paroxysmal nocturnal hemoglobinuria. American City Business Journals/Boston (7/23)
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Gates Foundation grants $4.5 million for HIV/AIDS vaccine research
The Bill & Melinda Gates Foundation has awarded the Scripps Research Institute grants worth more than $4.5 million to support the development of a vaccine against HIV/AIDS. Part of the money will go toward increased computer processing power to analyze data gathered through electron microscopy. KPBS-TV/KPBS-FM (San Diego)/City News Service (7/23)
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Government & Regulatory
European regulators support use of malaria vaccine
European regulators have recommended the use of GlaxoSmithKline's malaria vaccine Mosquirix, or RTS,S, for infants in Africa. The World Health Organization is reviewing clinical research and has said it will issue recommendations on use of the vaccine by the end of the year. Reuters (7/24), Time.com (7/24)
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More data on Sunesis' leukemia drug sought by FDA
The FDA has asked Sunesis Pharmaceuticals to submit additional data about its acute myeloid leukemia drug vosaroxin before submitting a marketing application. The European Medicines Agency has allowed the company to file a marketing application. A decision from the EMA is expected by 2016. Reuters (7/23)
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European regulators to review hepatitis C combo drug
MSD's marketing authorization application for its investigational grazoprevir/elbasvir combination drug has been accepted by the European Medicines Agency for review as a treatment for adult chronic hepatitis C patients with genotypes 1, 3, 4 or 6. The application was backed by data from four trials. The FDA is also reviewing the drug for the treatment of hepatitis C patients with genotypes 1, 4 or 6. PharmaTimes (U.K.) (7/23), Seeking Alpha (free registration) (7/23)
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FDA approves HIV assay
The BioPlex 2200 HIV Ag-Ab assay, developed by Bio-Rad Laboratories, has obtained approval from the FDA for use in detecting HIV-1 antibodies, HIV-2 antibodies and HIV-1 p24 antigens. The approval does not include screening of blood and plasma donors except in urgent cases. HCPLive (7/23), Medscape (free registration) (7/23)
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Association News
AABB posts analysis of FDA final rule on requirements for Blood and Blood Components
An AABB analysis of the FDA's Final Rule, "Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use," is now available online. An attachment to the analysis depicts amended sections of Title 21 of the Code of Federal Regulations. In this Final Rule, released on May 22, 2015, the agency amended certain sections of the CFR to make some of the requirements related to donor eligibility and donation suitability more consistent with current FDA recommendations and industry practices, as well as to set the stage for future technology by introducing areas of flexibility. FDA finalized many of the revisions proposed in 2007 without further change and modified several others. Some proposals from the 2007 Proposed Rule were not finalized in this rule, including those for reporting donor reactions. AABB submitted extensive comments on the proposed rule. High-profile revisions to the CFR include FDA's decision to raise the minimum hemoglobin requirement for male donors to 13.0 g/dL and to add a new section on control of bacterial contamination of platelets. However, the requirements in this new section are not expected to significantly affect AABB members. The final rule, reflected in updated sections of the CFR, becomes effective on May 23, 2016.
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