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12/5/2019

Sens. Chuck Grassley, R-Iowa, Elizabeth Warren, D-Mass., and three representatives expressed support for integrating the device identifier portion of unique device identifiers with electronic health insurance claims forms. The integration will help the FDA track patients affected when a device is recalled or fails.

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Regulatory Focus
12/5/2019

The FDA has granted investigational device exemption approval for the use of Personal Genome Diagnostics' elio tissue complete assay to guide patient enrollment and stratification in a trial of Merck's pembrolizumab-based combination therapy. The NGS test can detect all gene alteration classes and identify measures of tumor mutation burden and microsatellite instability.

12/5/2019

The FDA is seeking opinions on whether to create a pilot program that will evaluate the quality and toxicology of novel excipients. "FDA recognition of a novel excipient would mean that, based on a review of safety, manufacturing, and compositional information, FDA has determined that the proposed context of use... is expected to be safe. This determination would obviate the need for FDA review of the excipient in the context of an IND if its use in the investigational product is consistent with the recognized context of use," the agency wrote.

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Regulatory Focus
12/5/2019

Draft guidance was issued by the FDA providing recommendations for clinical trial enrollment criteria and endpoint selection in the development of drugs indicated for patients with interstitial cystitis or bladder pain syndrome. Sponsors will need to conduct two six-month trials to show efficacy of drug candidates.

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Regulatory Focus
12/5/2019

The World Health Organization released a report Wednesday that showed the fight against malaria has stalled due to a lack of new funding to support initiatives to counter the mosquito-borne disease. The report called on stakeholders to do more, noting that half of people around the world are at risk of contracting malaria and reductions in infections and mortality have declined more slowly in recent years.

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Reuters
12/5/2019

The CDC's most recent Antibiotic Resistance Threats Report says drug-resistant infections kill 35,000 people in the US annually, and although the US has achieved an 18% reduction in mortality associated with these infections, challenges remain, write HHS Secretary Alex Azar and CDC Director Robert Redfield. "The very nature of antibiotic resistance means that new threats are constantly emerging," they write.

12/5/2019

Omeros has released data from a midstage trial assessing OMS721, or narsoplimab, for treatment of thrombotic microangiopathy, a potentially deadly complication of hematopoietic stem cell transplant. Fifty-six percent of patients treated with at least one dose of narsoplimab achieved complete responder status, along with 68% of those treated four weeks or more.

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Seeking Alpha
12/4/2019

A $2.9 million grant from the NIH is funding research on male infertility at Emory University's Yerkes National Primate Research Center, the University of Georgia and the University of Pittsburgh that could benefit survivors of pediatric cancer, says reproductive science professor Kyle Orwig. Researchers are reprogramming skin cells into spermatogonial stem cells that restore sperm production when transplanted to the testes of rhesus monkeys, and if successful, the same technique might be used to restore sperm health and ovarian function.

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University of Georgia
12/4/2019

Thirty-seven percent of US adults have no plans to be vaccinated against influenza this season because they worry about the side effects, they think the vaccine is ineffective or they mistakenly think they might get the flu from the vaccine itself, according to a survey conducted by NORC at the University of Chicago. The CDC recommends annual vaccines for those 6 months and older, and as of early last month, 44% percent of adults said they had gotten the vaccine, and 18% had plans to do so.

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The Hill
12/4/2019

RightEye's eye movement-tracking vision system test for Parkinson's disease was granted breakthrough device designation by the FDA. The test requires patients to follow moving targets while viewing a tablet-style device.

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BioWorld MedTech
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RightEye