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7/27/2017

Chipotle executives revealed in an SEC filing they were served with another federal subpoena on July 19 asking for information related to a norovirus outbreak at a Chipotle in Sterling, Va. The subpoena was a follow-up to one issued Jan. 28 asking for "the production of documents and information related to company-wide food safety matters dating back to January 1, 2013."

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Food Safety News
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Chipotle, food safety, SEC, Norovirus
7/27/2017

Engineers at the University of Maryland, College Park, have invented a bio-compatible, ionic current-generating battery that produces the same ion-based electrical energy used by living things. The battery also includes a unique feature: It stores its energy in grass.

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ScienceDaily
7/27/2017

Chrysoeriol, a marijuana-based drug developed by Flabocure Biotech as a treatment for acute myeloid leukemia, has been granted orphan drug status by the FDA.

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Rare Disease Report
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FDA, Flabocure Biotech, Chrysoeriol
7/27/2017

A complete response letter has been issued by the FDA to Eagle Pharmaceuticals regarding its new drug application for Ryanodex, or dantrolene sodium, as a treatment for exertional heat stroke. The letter asks for an additional clinical study of the drug.

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FDA, Eagle Pharmaceuticals, Ryanodex
7/27/2017

Ablynx's caplacizumab as a treatment for patients with acquired thrombotic thrombocytopenic purpura has been granted fast-track status by the FDA. The company anticipates completion of a late-stage study of the drug by October.

7/27/2017

The FDA has given Spectranetics approval for its Stellarex drug-coated balloon, a device intended for use in treating peripheral artery disease and superficial femoral or popliteal lesions. The approval was backed by results from the ILLUMENATE pivotal trial, which showed use of the balloon led to low clinically driven target lesion revascularization rates and high patency rates for a wide range of lesion complexities and patient comorbidities.

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FDA, Spectranetics, Spectranetics
7/27/2017

Surmodics has obtained an investigational device exemption from the FDA to conduct a pivotal clinical trial of its SurVeil drug-coated balloon. The 446-patient study, which has a primary endpoint of primary patency at 12 months, seeks to assess use of the next-generation device for treating peripheral artery disease in the upper leg, compared with Medtronic's IN.PACT Admiral DCB.

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FDA, SurModics, Medtronic
7/27/2017

Health Canada has given Medtronic Canada approval for its line of MRI-conditional cardiac resynchronization therapy defibrillators, which include the Compia MRI Quad CRT-D SureScan and Amplia MRI Quad CRT-D SureScan systems. With the approval, the devices, which can work with the company's Attain Performa MRI SureScan quadripolar leads, can now be used for MRI scans on any body part without restrictions to positioning.

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MassDevice (Boston)
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Medtronic Canada, Health Canada
7/27/2017

Effector Therapeutics gained $38.6 million from a Series C funding round that will be used to test small-molecule drugs for a specific group of proteins that control anti-tumor immune response. Effector also plans to use the additional funds to advance midstage trials for its lead candidate eFT508 that targets lymphoma and multiple solid tumors.

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Xconomy
7/27/2017

Bavarian Nordic and Johnson & Johnson unit Janssen Pharmaceuticals have expanded their collaboration, granting the latter exclusive rights to Bavarian's MVA-BN technology for vaccine programs that target HIV-1 and hepatitis B. The deal includes upfront equity investment and milestone payments worth up to $879 million.

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Reuters