Life Sciences
Top stories summarized by our editors
1/17/2019

European regulators have given CE mark approval for Aseptika's Activ8rlives4 health and wellness app. The app gathers health data, including weight, exercise and medication adherence, and reveals patterns through charts and tables.

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FDAnews
1/17/2019

An analysis of data from over 4,200 US hospitals found that 1 in 4 hospitals cut staff between 2015 and 2017 to ease budget pressures as a result of rising drug spending. Hospital drug spending climbed by 18.5% during the period, with costs driven mainly by high list prices and shortages of critical drugs such as saline and generic injectables.

1/17/2019

Theradiag has received CE mark approval for its Lisa Tracker drug response kit for Novartis' Cosentyx, which treats psoriasis, psoriatic arthritis and ankylosing spondylitis. Lisa Tracker kits help physicians monitor serum levels of circulating TNF-alpha, prescribed TNA-alpha inhibitors and drug neutralizing antibodies.

1/17/2019

Qiagen has received approval from the Japanese Pharmaceuticals and Medical Devices Agency for the use of its Therascreen EGFR RGQ PCR kit as a companion diagnostic with Pfizer's Vizimpro for EGFR mutation-positive, inoperable or recurrent non-small cell lung cancer. The kit is Qiagen's first companion diagnostic to be approved in the country.

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Qiagen, Pfizer
1/17/2019

The FDA has given fast-track designation to Acurx Pharmaceuticals' investigational new drug ACX-362E to treat Clostridium difficile infections. An early-stage trial is evaluating the oral antibiotic's safety and efficacy in patients with CDI.

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MD Magazine online
1/17/2019

Roche Holding's supplemental biologics license application for Tecentriq plus chemotherapy (abraxane and carboplatin) as a first-line therapy for patients with metastatic non-squamous non-small cell lung cancer has been accepted by the FDA for review. The agency has set a PDUFA date of Sept. 2.

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Reuters
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Roche, Tecentriq
1/17/2019

An FDA advisory committee voted 18-1 in favor of Amgen's Evenity, or romosozumab, as a treatment for postmenopausal women with osteoporosis who are deemed to be at high risk for bone fractures.

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FiercePharma
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Evinity
1/17/2019

A first tranche round of Series B funding pulled in $46 million for Juvenescence, which invests in new companies that develop therapies for aging or age-related disease.

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BioCentury
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Juvenescence
1/17/2019

Roche Holding has announced the launch of uPath, touted as an upgrade to its Ventana Virtuoso image-management software. The uPath software's features include automated image analysis, easier sharing of cases between pathologists and single-view inspection of all slides in a case.

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FierceBiotech
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Roche
1/17/2019

Roche Holding agreed to collaborate with Phoenix Molecular Designs to develop an assay that will detect activation of RPS6KA3 in patients with triple-negative breast cancer. Phoenix intends to use the diagnostic in a Phase I/Ib trial of its drug candidate PMD026 this year.

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BioCentury
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Phoenix Molecular Designs, Roche