Life Sciences
Top stories summarized by our editors
12/11/2019

Ontera has signed a deal with QuantuMDx to develop technology to detect bloodstream infections and drug resistance using Ontera's nanopore biosensor and QuantuMDx's Capture-XT preparation technology. The firms did not disclose the financial details of the deal.

More Summaries:
QuantuMDx
12/11/2019

Inscripta, a startup that has developed a benchtop automated genome engineering instrument, raised $125 million in its most recent funding round. The company plans to use the new capital to commercialize the Onyx Digital Genome Engineering platform and broaden its applications.

12/11/2019

A Series C financing round has raised $85 million for Imperative Care. The company is preparing to launch a large distal platform access technology and its Zoom aspiration system.

Full Story:
MassDevice (Boston)
12/11/2019

Adaptive Biotechnologies and AbbVie will collaborate on use of the former's clonoSeq assay to determine patients' minimal residual disease status in various trials assessing venetoclax as a treatment for multiple myeloma. No other disclosures were made regarding the terms of multi-year, global deal.

12/11/2019

The FDA has cleared a new application in orthopedic trauma for Orthogrid Systems' intraoperable PhantomMSK platform. The PhantomMSK aids in aligning bone fractures and improves intraoperative efficiency using artificial intelligence-trained and augmented reality-based decision support.

Full Story:
BioWorld MedTech
12/11/2019

Abbott is warning of two issues with its advanced heart failure implant. Incorrect connection of the HeartMate 3 modular cable can cut electrical power to the pump, while separate reports cite power loss to HeartMate mobile power unit modules caused by static electricity.

Full Story:
MedTech Dive
More Summaries:
HeartMate
12/11/2019

A report from WebMD and Georgia Health News shows people living about a mile away from a Medline sterilization plant have blood levels of ethylene oxide that are 50% higher than those who live farther. However, participants were not randomly selected and the results may be biased and have not been published in a peer-reviewed publication.

12/11/2019

Seventh Sense Biosystems has obtained 510(k) clearance from the FDA for its Tap, a push-button blood collection device for use by laypersons.

More Summaries:
Seventh Sense Biosystems
12/11/2019

The FDA has issued warning letters to Teligent Pharma and OHM Pharma over violations of good manufacturing practices.
Teligent was cited for not thoroughly investigating of out-of-specification test results for a lot of clobetasol propionate before distributing it two years ago, while OHM was cited for issues with cleaning, laboratory controls and manufacturing practices.

Full Story:
Regulatory Focus
More Summaries:
Teligent, OHM
12/11/2019

The Australian Therapeutic Goods Administration has warned that Mylan's epinephrine injection EpiPen Jr will not be available until a shipment from the US arrives around Dec. 17. The agency disclosed that it allowed Mylan to supply a batch of EpiPen Jr that did not pass quality specifications following notice from Mylan of the shortage.

Full Story:
Regulatory Focus