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7/27/2016

Janssen's Darzalex, or daratumumab, has been granted breakthrough therapy designation by the FDA for use in combination with Revlimid, or lenalidomide, and dexamethasone, and Velcade, or bortezomib, and dexamethasone for the treatment of multiple myeloma patients who have received at least one previous therapy. The designation was based on data from two late-stage studies.

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OncLive
7/27/2016

Nine different salads and sandwiches are being recalled by Meijer after its supplier, Prime Foods, recalled an ingredient in its products due to potential salmonella contamination. The affected items were sold in stores between July 20 and 25.

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Meijer, salmonella, Prime Foods
7/27/2016

Mainstay model organisms such as fruit flies, mice and roundworms have contributed to countless research breakthroughs, but some experts think science can be advanced even further with the development of novel model organisms. Advances in genomic sequencing and editing are fueling new interest in less traditional creatures such as freshwater flatworms, crustaceans, squid and corals that might be able to shed new light on biology and disease.

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Quanta Magazine
7/27/2016

Dolly the sheep, the world's first cloned mammal, lived less than seven years, but a paper published in Nature Communications suggests her status as a clone had nothing to do with her short lifespan. Dolly's "sister clones" -- Daisy, Debbie, Denise and Diana -- just marked their ninth birthday and are in good health and within the normal range for blood pressure, metabolism, heart function and a variety of other metrics.

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National Public Radio
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Dolly, Nature Communications
7/27/2016

An initial public offering brought in $75 million for autoimmune and oncology treatment developer Kadmon Holdings. The firm's most advanced product candidates, KD025, a treatment for autoimmune and fibrotic disease, and XL647, or tesevatinib, an oncology treatment, are in midstage trials.

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BioCentury
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Kadmon Holdings
7/27/2016

Allergan's Truberzi, or eluxadoline, has been endorsed by the European Medicine Agency's Committee for Medicinal Products for Human Use as a treatment to manage symptoms of diarrhea-predominant irritable bowel syndrome in adults. The recommendation was based on two studies that showed significant reduction of abdominal pain and diarrhea in treated patients, with relief sustained over six months.

7/27/2016

A recent report from the European Court of Auditors said the European Commission's existing biofuels sustainability certification framework contains gaps, and the European renewable ethanol association, which agrees with the findings, is calling for a number of measures to improve the sustainability of biofuels. The group urged the EU to ensure that only European ethanol and other entirely sustainable biofuels are backed by the commission's policy after 2020.

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EthanolProducer.com
7/27/2016

Inflation in India is largely driven by the prices of beans, chickpeas and lentils, and the use of biotech pigeon peas could boost yield up to 30% and help the country meet its long-term inflation target. Biologists from southern India are testing a pest-resistant biotech pigeon pea variety and say biotechnology is the only way to increase productivity of the crop.

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Bloomberg
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India
7/27/2016

The FDA lowered the generic application fee rates for fiscal 2017, with abbreviated new drug applications fees reduced from $76,030 in 2016 to $70,480 and prior approval supplement fees reduced from $38,020 to $35,240. The new fees will be in effect from Oct. 1 of this year through Sept. 30, 2017.

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Regulatory Focus
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FDA
7/27/2016

The FDA granted orphan drug designation to Araim Pharmaceuticals' innate repair receptor activator ARA 290 as a treatment to improve pancreatic islet functioning and improve survival in type 1 diabetes patients who undergo pancreatic islet cell transplantation. The drug boosted survival and function of transplanted islets by 85% in an animal model.

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PharmaBiz.com (India)
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FDA, Araim Pharmaceuticals