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5/24/2018

Fifty-eight cases of Ebola have been reported in the Democratic Republic of Congo, including 27 deaths, according to the World Health Organization. WHO also said that over $25 million is coming from the US, Germany and the World Bank to support the response to the outbreak.

5/24/2018

An update presented at a meeting of the World Federation of Hemophilia indicates that BioMarin Pharmaceutical's gene therapy candidate valoctocogene roxaparvovec continues to exhibit clinical benefits for patients with severe hemophilia A. Annualized bleeding rates were reduced by 97% while average factor VIII usage was reduced by 98%.

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5/24/2018

The All of Us Research Program expects to issue funding this fiscal year for up to two genome centers to generate genotype and whole genome sequence data from study participants' samples. Program directors also announced the impending launch of a pilot study to determine how to make data available to participants and ensure participants are educated about those data.

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Bio-IT World
5/24/2018

Researchers who want to link information on whether and how well cancer treatments have worked in the real world with genomic data have found that medical records are incredibly difficult to obtain, even when patients grant permission, and data in those records are not standardized. Instead of sending electronic medical records, hospitals and health systems often send faxes instead, and researchers must input data manually.

5/23/2018

House lawmakers approved legislation Tuesday that would allow terminally ill patients to request access to experimental drugs that have undergone early-stage clinical trials but have yet to receive approval from the FDA. The bill, which would not require pharmaceutical companies to provide the drugs, was passed by the Senate last year and now goes to President Donald Trump for his expected signature.

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House
5/23/2018

Revibe of Missouri, Colorado-based Front Range Kratom and Kratom Spot of California received warning letters from the FDA about selling kratom-containing, illegal, unapproved products, which the firms claim could treat opioid addiction and withdrawal, pain and cancer, as well as lower blood pressure and lessen neuron damage caused by stroke. The agency determined that kratom, which is listed as a "drug and chemical of concern" by the Drug Enforcement Administration, has similar effects to narcotics and has led to dozens of deaths.

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Reuters
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FDA
5/23/2018

The FDA issued warning letters to companies selling dietary supplement pills and capsules, such as Solaricare, Sunsafe Rx, Sunergetic and Advanced Skin Brightening Formula, which claim to protect against the sun. FDA Commissioner Scott Gottlieb said any ingestible sun protection product would be considered a drug, and the FDA has not approved a drug with that claim.

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USA Today
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Commissioner Scott Gottlieb
5/23/2018

Sanofi's marketing application for Zynquista, or sotagliflozin, was accepted by the FDA for review. The drug is used as an add-on to insulin to help adult patients with type 1 diabetes achieve better blood sugar control.

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Sanofi, Zynquista
5/23/2018

Eli Lilly's and Co.'s Taltz, or ixekizumab, is the first medication for moderate to severe plaque psoriasis to receive FDA approval to include on its label data on psoriasis involving the genital area. The drug was previously approved as a treatment for patients with psoriatic arthritis and plaque psoriasis.

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Seeking Alpha
5/23/2018

FDA Commissioner Scott Gottlieb is paving the way for drug developers to advance more gene therapies for various diseases by creating a framework that will guide gene therapy manufacturers. "The first therapeutic area we'll focus on is hemophilia, where factor production may be sufficient in some cases as a surrogate measure of benefit where a gene therapy product can potentially normalize factor production," Gottlieb said.

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BioCentury, Endpoints News
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Commissioner Scott Gottlieb, FDA