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Top stories summarized by our editors
7/2/2020

Novartis is building a facility in Indianapolis that will manufacture Lutathera, a drug that treats neuroendocrine tumors, due to high demand for the radioligand drug. Other radiotherapies will be also made at the plant, which will be the second US facility for Novartis when it opens in 2023.

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FiercePharma
7/2/2020

The FDA plans to move away from multiple PDFs for clinical trial safety data and will begin using digital submissions, says Meredith Chuk, acting associate director for safety at the FDA's Office of Oncologic Diseases. Calling the PDF system "extremely inefficient," Chuk says the new process will give regulators more insight into safety data.

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Regulatory Focus
7/2/2020

Data from a 55-patient study in the American Society for Artificial Internal Organs Journal showed positive results for Abiomed's Impella 5.5 with SmartAssist heart pump in the US. "This report demonstrates the benefit of unloading cardiogenic shock patients, and it is encouraging to see real-world data demonstrate improved survival rates with use of Impella 5.5 with SmartAssist," said Danny Ramzy, Cedars-Sinai Medical Center's director of robotic and minimally invasive surgery.

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MassDevice (Boston)
7/2/2020

An offering of approximately 37.3 million shares of common stock is expected to bring in $13 million in proceeds for TransEnterix. The offering, closing on or around July 6, includes a 45-day option for underwriters to buy almost 5.6 million more shares.

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MassDevice (Boston)
7/2/2020

Preliminary results from a study by University of Virginia School of Medicine researchers showed that a blood test was able to help identify which patients with new coronavirus infections would need a ventilator. The findings, which have not been peer-reviewed, have been reported on the website medRxiv.

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HealthDay News
7/2/2020

Eurofins has launched the INgezim dual-recognition immunochromatographic assays, which are finger-prick point-of-care testing devices that can deliver results within 10 minutes and identify previous exposure to COVID-19. The tests have received CE mark approval.

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MassDevice (Boston)
7/2/2020

The Mariner Outrigger and Mariner MIS spinal fixation systems have been released by SeaSpine. The Mariner Outrigger improves surgical flow in revision spinal fusions, while the Mariner MIS is used to correct sagittal balance and stabilize hybrid constructs.

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Becker's Spine Review
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SeaSpine
7/2/2020

The compliance date for unique device identifier requirements for Class I devices, unclassified medical devices and certain other devices has been extended by the FDA to Sept. 24, 2022.

7/2/2020

The FDA, under a supplemental marketing application, has granted Axonics Modulation Technologies 3T full-body MRI conditional labeling for its Axonics r-SNM System.

7/2/2020

The FDA has given emergency use authorization to Kroger for its COVID-19 Test Home Collection Kit that will allow people to perform nasal swab sample collections on their own with the virtual supervision of a health care provider.

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FDAnews