Life Sciences
Top stories summarized by our editors
11/16/2018

A preliminary prospectus has been filed by Valeritas for a public offering of around 44.1 million shares of common stock and Series A and B share purchase warrants, up from about 27.8 million shares and warrants filed for previously.

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Valeritas
11/16/2018

A public offering of approximately 2.1 million Class A common shares has been priced by Helius Medical Technologies at $8.25 each.

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Helius Medical Technologies
11/16/2018

Aetna has issued a positive coverage policy for Pulmonx's Zephyr endobronchial valve system, naming it as an approved bronchoscopic option for lung volume reduction. The device is designed for treating severe emphysema and chronic obstructive pulmonary disorder.

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MassDevice (Boston)
11/16/2018

NuVasive has launched the Brigade Lateral implant for lateral anterior lumbar interbody fusion spine surgery. The implant provides a low-profile and reproducible insertion process to improve surgical workflow in the operating room.

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Becker's Spine Review
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NuVasive
11/15/2018

The FDA has warned StemGenex Biologic Laboratories for selling an unapproved stem cell product as part of a crackdown on sales of regenerative medicines for unapproved indications. The warning letter also noted manufacturing process violations that could create a risk of microbial contamination.

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Endpoints News
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FDA
11/15/2018

Regenxbio's RGX-181, being developed as a one-time therapy for late-infantile neuronal ceroid lipofuscinosis type 2 disease, was given orphan drug status by the FDA.

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11/15/2018

The FDA has granted Canon Medical Systems USA clearance to market its Vantage Orian 1.5 Tesla MRI scanner, which comes with a 71 cm bore, as well as Pianissimo and Pianissimo Zen technologies for quiet operation.

11/15/2018

European regulators have given Diabeloop CE mark approval for its DBLG1 technology, a self-learning and customizable device for monitoring and maintaining glucose levels. The system, which can imitate the insulin-dispensing functions of the pancreas, connects to an insulin patch pump and a continuous blood glucose monitoring system to predict glucose levels and enable optimal pump control.

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FDAnews
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EU
11/15/2018

Testing by the Government Accountability Office revealed that two dietary supplements, which were sold as ginkgo-based memory boosters, do not contain the ingredient or contain a lower amount than marketed. The FDA will review the GAO report and may conduct further investigation.

11/15/2018

A marketing application was filed with the FDA by Eli Lilly and Co. for lasmiditan as an acute treatment for adult patients with migraine with or without aura.

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Eli Lilly, FDA