Life Sciences
Top stories summarized by our editors
5/23/2019

Experts from the Congressional Budget Office who testified Wednesday during a House committee hearing on single-payer health care said the framework would likely increase the number of people with health insurance, but it would also increase government control over the health care system. With health care representing about one-sixth of the US economy, changes resulting from the shift to a single-payer system could be "potentially disruptive" and could have a significant impact on the economy, as well as health care access and quality, said CBO Deputy Director Mark Hadley.

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The Hill
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Congressional Budget Office
5/23/2019

Iovance Biotherapeutics' LN-145, being developed to treat patients with recurrent, metastatic or persistent cervical cancer that has progressed after or during chemotherapy, has been granted breakthrough therapy status by the FDA.

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Seeking Alpha
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Iovance Biotherapeutics, FDA
5/23/2019

A recall of Integra LifeSciences' MoniTorr and LimiTorr drainage devices has been labeled Class I by the FDA. The devices, which facilitate cerebrospinal fluid drainage from the lumbar subarachnoid space or the ventricles of the brain, were recalled after reports of external valve breakage during tightening of connections.

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FDAnews
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Integra LifeSciences, FDA, Integra
5/23/2019

The FDA has granted AngioDynamics an investigational device exemption approval for a nonrandomized pilot study of its NanoKnife device. The study will enroll six participants at up to three centers and aims to support approval of the device, which uses irreversible electroporation to treat focal prostate lesions.

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MassDevice (Boston)
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FDA, AngioDynamics
5/23/2019

The FDA has granted Philips Healthcare 510(k) clearance for the Magnetic Resonance for Calculating Attenuation pelvis software, which facilitates radiation therapy planning using a single MRI exam for cancers in the pelvis.

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Philips Healthcare, FDA, Philips
5/23/2019

Aurora Packing issued a recall for more than 62,000 pounds of raw beef products because they could be contaminated with E. coli.

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USA Today
5/23/2019

The European Commission has given conditional approval to Pfizer's Lorviqua, or lorlatinib, as a monotherapy for patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer.

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FDAnews
5/23/2019

China's National Medical Products Administration has conditionally approved GlaxoSmithKline's shingles vaccine Shingrix based on data obtained in other countries. The drug is approved for patients age 50 and older.

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FiercePharma
5/23/2019

Chugai Pharmaceutical will invest $1.15 billion in a new research and development facility in Yokohama, Japan, which will house two of its existing research labs from nearby cities. Construction is slated to begin in August and is expected to be completed by August 2022, and the site is anticipated to be operational in January 2023.

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FierceBiotech
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Chugai Pharmaceuticals, Japan
5/23/2019

Amgen has proposed to acquire partner Nuevolution for about $167 million in cash. Amgen expects to integrate Nuevolution's Chemetics platform into the pharma's cancer and neurology research.

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BioCentury
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Amgen, Nuevolution