Life Sciences
Top stories summarized by our editors
1/23/2018

A Class I recall was issued by National Frozen Foods for three lots of frozen green beans sold in Department of Defense commissaries because of potential listeria contamination after a Jan. 19 recall by JustFoodForDogs for green bean-containing dog foods that also tested positive for listeria. Neither of the companies confirmed that NFF's green beans were the cause of the dog food recall.

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Food Safety News
1/23/2018

Perhaps there's a ray of hope that venture capital funding is recovering a bit for the medical device industry. VC firms invested more than $2.8 billion in 2017, an increase of more than $647 million from 2016, according to the MoneyTree Report from PwC and CB Insights. The companies raking in the VC cash are doing everything from creating robotic microsurgery for the eyes to building better dialysis machines to bringing neuromodulation to bear on epilepsy. Read on to discover which medtech companies raised the most venture capital.

1/23/2018

A complete response letter was issued by the FDA to Braeburn Pharmaceuticals for its new-drug application for CAM2038, a monthly buprenorphine injection using Camurus' FluidCrystal injection depot technology to treat patients with opioid use disorder. The FDA asked for additional data from the company but did not request further clinical studies.

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BioCentury
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Braeburn Pharmaceuticals
1/23/2018

Omeros' OMS721 was recommended by a European Medicines Agency panel to receive an orphan drug designation for the treatment of IgA nephropathy. The company expects to launch a late-stage study of the drug in February.

1/23/2018

A measure approved by the Senate and House to keep the federal government open through the first week of next month and suspend the medical device tax for two years was signed by President Donald Trump on Monday. "Congress' action to once again suspend the medical device tax -- just days before medical technology innovators were set to start cutting checks to the IRS -- means funds will not be diverted from current investments in jobs, capital improvements, and research into new treatments and cures," said AdvaMed President and CEO Scott Whitaker.

1/23/2018

The FDA granted Surmodics 510(k) clearance for its Telemark 0.014-inch support microcatheter, which is designed for use in unblocking blood vessels in the legs or heart that are obstructed with calcified plaque. The device, which is intended to be inserted into the vessels before a second device is inserted for opening the vessel and placing a stent, comes with a proprietary hydrophilic coating that makes it slippery and prevents particles from being left behind in the body.

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SurModics, SurModics
1/23/2018

The FDA cleared Medrobotics' Flex robot-assisted surgery device for robot-assisted visualization in general surgical, thoracic and gynecological procedures. The device previously won FDA clearance for transoral procedures.

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MassDevice (Boston)
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Medrobotics
1/23/2018

Sanofi's recent acquisition of Bioverativ, a maker of hemophilia drugs, and Celgene's buyout of cell therapy developer Juno Therapeutics, investments worth over $20 billion collectively, are expected to advance the development of more hemophilia treatments and chimeric antigen receptor T-cell therapies. Sanofi is counting on sales from Eloctate and Alprolix, Bioverativ's blood-clotting drugs, while Celgene will cultivate other CAR-T cancer immunotherapies, including JCAR017 for non-Hodgkin lymphoma.

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Xconomy
1/23/2018

A round of Series D funding brought in $60 million for cancer company Eureka Therapeutics. The company anticipates launching an early-stage trial of ET190L1-ARTEMIS for the treatment of patients with relapsed or refractory CD19-positive non-Hodgkin lymphoma.

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BioCentury
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Eureka Therapeutics
1/23/2018

The European Court of Justice Advocate General published a legal opinion arguing that New Plant Breeding Techniques, including CRISPR-Cas, shouldn't be subject to the same regulations as other techniques because foreign DNA is not used. "Mutagenesis techniques are exempt from the obligations of the [biotech] Directive provided that they do not involve the use of recombinant nucleic acid molecules or [biotech organisms]," the opinion said.

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FoodNavigator
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European Commission