Lab Sciences
Top stories summarized by our editors
9/24/2018

Efforts to curb the spread of the Ebola virus in and near the town of Beni in the Democratic Republic of Congo were interrupted Saturday by a rebel attack in the area that killed at least four soldiers and 14 civilians. Local authorities reported the death due to the virus of a Congolese woman near the Ugandan border after she had declined vaccination and left Beni.

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Reuters, ABC News
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Ebola
9/24/2018

People who contracted HIV and hepatitis through blood products in the UK in the 1970s and 1980s testified at the beginning of an inquiry into the National Health Service and its practices at the time. An estimated 5,000 UK residents with bleeding conditions including hemophilia contracted the viruses through injections of pooled and concentrated blood products.

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BBC
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HIV, National Health Service
9/24/2018

Two studies provide new information on a rare but significant group of HIV patients known as post-treatment controllers who have maintained viral control despite cessation of antiretroviral therapy. Findings from the first study established the correlation between PTC status and early treatment and were published in The Journal of Infectious Diseases, while results from the second study, which dealt with the biological mechanisms in PTCs, were reported in The Journal of Clinical Investigation.

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MD Magazine online
9/24/2018

Jivi, or damoctocog alfa pegol/BAY94-9027, a product of Bayer, has received approval from Japanese regulators for the prevention of bleeds in patients with hemophilia A ages 12 and older. Jivi is now under regulatory review in Europe.

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PMLive (UK)
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Bayer, Jivi
9/21/2018

A study of blood serum levels of chemokines among women with and without sickle cell disease found that the protein IP-10 may be an indicator of inflammation for women with sickle cell disease during pregnancy. From that group, blood samples were collected in the second trimester of pregnancy and at least a month after transfusion, according to the study in the journal Cytokine.

9/21/2018

The World Health Organization said Uganda is preparing a vaccination campaign if the Ebola virus spreads there from the neighboring Democratic Republic of Congo. The WHO, which is helping Uganda, said the country would use a "ring vaccination" strategy focusing on health care workers and contacts of people with the illness.

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Reuters
9/21/2018

The Trump administration has released a new biodefense plan that does not address the potential of climate change to affect the spread of disease. The plan calls for greater understanding of the origins of biological threats and how they can be prevented, and it highlights dangers including biological warfare, drug-resistant pathogens, food-borne illnesses, agricultural disease and laboratory accidents.

9/20/2018

Black people and Native Americans are inadequately represented in clinical trials of new drugs, even though the therapies are often developed for diseases that inordinately affect them, according to a ProPublica analysis. Results showed that blacks made up less than 5% of clinical trial participants for 24 of 31 cancer treatments approved by the FDA since 2015, and nearly two-thirds of trials mostly done in the US had no Native American patients.

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ProPublica
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FDA, FDA, ProPublica
9/20/2018

Merck's single-pill combination drug consisting of doravirine, lamivudine and tenofovir disoproxil fumarate was found to be safe, effective and noninferior to a regimen of efavirenz, emtricitabine and tenofovir disoproxil fumarate as a therapy for treatment-naive adults with HIV-1 infection, researchers reported in Clinical Infectious Diseases. The trial was conducted at 126 sites around the world with 734 adult participants.

9/20/2018

Final guidance on reducing risks tied to medical devices and combination products that contain heparin has been released by the FDA's Center for Devices and Radiological Health. With the guidance, CDRH aligns its policies with the US Pharmacopeia drug substance and product monographs for heparin lock flush solution, heparin sodium and heparin sodium injection.

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Regulatory Focus