Life Sciences
Top stories summarized by our editors
5/22/2018

Ten percent of parents reported that their children developed foodborne illnesses, and 68% of them cited restaurants as the source of contaminated or spoiled food, but only 25% said they check restaurants' health ratings before dining out, according to a national poll by the University of Michigan's C.S. Mott Children's Hospital. The findings also showed that a third said their children got sick from food at home.

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HealthDay News
5/22/2018

Minnesota has the institutions and the talent to transform health care in the US. The question is whether the money will follow. So far, funding for Minnesota medtech startups has been a mixed bag. Unlike the nation as a whole, quarterly medtech startup fundraising in the North Star State has yet to return to pre-Great-Recession levels, according to PwC and CB Insights' MoneyTree report. The Minnesota-based Medical Alley Association, however, points out that investment is growing when it comes to digital health. Widen the lens to include all of the life science companies in the state, and there were 26 that raised $112 million during the first three months of 2018, according to Medical Alley. More than half the companies were focused on tools and technologies related to consumer-focused health care. (See it for yourself at MassDevice and MDO's DeviceTalks Minnesota, June 4-5 in St. Paul.) Read the story.

5/22/2018

The FDA approved a fifth indication for Amgen's Prolia, or denosumab, as a treatment for glucocorticoid-induced osteoporosis in men and women with high fracture risk. The approval was based on late-stage trial data that showed patients who took denosumab had greater gain in bone mineral density than those who received risedronate.

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MD Magazine online
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Amgen, FDA, denosumab, Prolia
5/22/2018

ViiV Healthcare and Janssen Pharmaceutical said they received marketing authorization from the European Commission for Juluca, or dolutegravir/rilpivirine, which is indicated for patients with HIV-1 infection who are virally suppressed on a stable antiretroviral regimen for a minimum of six months with no treatment failure history and no resistance to an integrase inhibitor or non-nucleoside reverse transcriptase inhibitor. Juluca is the first two-compound, single-tablet HIV drug approved by the EU for HIV maintenance.

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Seeking Alpha, BioCentury
5/22/2018

A recall was initiated by Ziyad Brothers Importing over its Tahini Sesame Paste after the product was found to be contaminated with salmonella in a random sampling by the Michigan Department of Agriculture and Rural Development. Products in the recall have the lot codes 35417, 00318, 35317, 35417, 35517, 35617, 34817, 01218 and 34917 and were sold by retailers, including Walmart stores, nationwide.

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Food Safety News
5/22/2018

The FDA granted Johnson & Johnson subsidiary Cerenovus 510(k) clearance for its Embotrap II Revascularization Device, a next-generation stent retriever designed for capture and removal of blood clots from the brain to restore blood flow in the neurovasculature after an ischemic stroke. The device, which is indicated to be used within eight hours after the first appearance of stroke symptoms, is suitable for use in patients who do not respond to or are ineligible for intravenous tissue plasminogen activator therapy.

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Johnson & Johnson, Cerenovus
5/22/2018

Inari Medical's FlowTriever System was granted 510(k) clearance by the FDA for use in pulmonary embolism treatment. The thrombectomy device allows blood clots in the pulmonary arteries to be removed nonsurgically without the need for thrombolytic drugs and while preventing the risk of bleeding complications.

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MD Magazine online
5/22/2018

Data from a Phase III trial showed Janssen Pharmaceutical's Erleada, or apalutamide, reduced the risk of prostate-specific antigen progression by 94% compared with placebo in patients with nonmetastatic castration-resistant prostate cancer receiving continuous androgen deprivation therapy. Metastasis-free survival, the trial's primary endpoint, also improved by two years among patients who received Erleada plus ADT.

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Janssen Pharmaceutical, Janssen
5/22/2018

An oversubscribed Series C financing round that included Chinese investors raised $300 million for Grail, a developer of blood-based diagnostics for early cancer detection. Grail's Circulating Cell-Free Genome Atlas study aims to produce a detailed cancer genetics atlas, while its STRIVE trial is focused on developing a pan-cancer diagnostic test and validating a breast cancer assay.

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BioCentury
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breast cancer, cancer
5/22/2018

The testing of biotech mosquitoes as a means of eradicating Aedes aegypti mosquitoes will resume in the Cayman Islands later this month. The project will also use traditional mosquito management strategies, such as spraying insecticides from a plane, once the biotech mosquitoes are released into the test areas.

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Cayman Islands