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8/20/2018

FDA orphan drug status was given to Aslan Pharmaceuticals' acute myeloid leukemia drug candidate ASLAN003.

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Seeking Alpha
8/20/2018

AbbVie and Tolero Pharmaceuticals have partnered to evaluate the safety and efficacy of Venclexta, or venetoclax, in combination with the latter's alvocidib as a treatment for patients with relapsed/refractory acute myeloid leukemia. The companies will share development costs equally.

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FierceBiotech
8/20/2018

An initial public offering was filed by Entasis Therapeutics seeking to raise $86.3 million. The company plans to launch late-stage trials of ETX0914, or zoliflodacin, for uncomplicated gonorrhea indication, and ETX2514SUL for the treatment of severe Acinetobacter baumannii infections next year.

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BioCentury
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Entasis Therapeutics
8/20/2018

Plant biologists Barbara Doyle Prestwich and Eoin Lettice have called the Irish government's decision to restrict or prohibit the cultivation of biotech crops approved elsewhere in Europe "a grave mistake." "It is grossly misleading to equate 'GMO cultivation-free status' with 'green, sustainable food [production]' which is the basis for which Minister [Denis] Naughten recommended opting out of growing GM crops in Ireland," says Lettice.

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AgriLand (Ireland)
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Ireland
8/20/2018

An enzyme called glycerol-3-phosphate acyltransferase 1 was found to accelerate biofuel production from red alga Cyanidioschyzon merolae by more than 56 times without impacting algae growth, according to a study conducted by Tokyo Institute of Technology researchers.

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Biofuels Digest
8/20/2018

AdvaMed has submitted comments on the FDA's five-pronged action plan for promoting safety of medical devices, raising concerns on the proposal's merit and logistics, including the implementation of a CyberMed Safety Analysis Board. The board's "makeup, selection, authority, training and expertise is not clear, and the notion that it would be granted power to inspect or investigate real world vulnerability events and make decisions requires further discussion," said Zachary Rothstein, associate vice president for technology and regulatory affairs at AdvaMed.

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Regulatory Focus
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FDA, AdvaMed
8/20/2018

The Turkish government has postponed for the third time a tender valued at around $10 billion for the production and delivery of 43,327 patient monitoring systems, 7,142 ultrasonography devices, 3,236 digital radiography devices, 538 computed tomography devices and 350 MR screening devices, with production involving local partners. The bidding process is now set to take place Oct. 31.

8/20/2018

An equity offering has been closed by BioSig Technologies at approximately $6 million. The company recently received FDA clearance to market its Pure EP system.

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Seeking Alpha
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BioSig Technologies, FDA
8/20/2018

Hologic has announced the US launch of its Fluent fluid-management system for use in hysteroscopic procedures. The system is designed to streamline use and improve fluid management with its advanced FloPak technology.

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Compelo
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Hologic
8/20/2018

Terumo's premarket approval application for its WEB aneurysm embolization system for the wide-neck intracranial aneurysms at a vessel bifurcation will be considered by the FDA's Neurological Devices Panel on Sept. 27. The company based its application on data from a 150-patient trial of the system.

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FDA, Terumo, PMA