Life Sciences
Top stories summarized by our editors
4/24/2019

The US attorney's office alleges Rochester Drug Co-Operative, a major drug distributor, conspired to violate narcotics laws, among other charges related to the opioid crisis. Additionally, the company's former CEO and former chief compliance officer have been charged with conspiracy to distribute controlled substances and conspiracy to defraud the US.

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NBC News, TIME online
4/24/2019

A House panel will hold a hearing on Tuesday to discuss the "Medicare-for-all" bill introduced by Reps. Pramila Jayapal, D-Wash., and Debbie Dingell, D-Mich. The hearing, the first to focus on "Medicare-for-all," will be hosted by the House Rules Committee, after the House Energy and Commerce Committee and the Ways and Means Committee declined to take up the bill amid a divide among Democrats over the legislation.

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The Hill
4/24/2019

A mutation in the SFTPC gene causes such severe lung dysfunction that most children with the mutation die shortly after birth, but a proof-of-concept study published in Science Translational Medicine suggests in utero genetic editing could correct the mutation. Scientists injected a CRISPR-edited gene into the amniotic fluid of mice and successfully inactivated the gene in 20% of them.

4/24/2019

The FDA has issued draft guidance to help manufacturers avoid delays in preparing, planning and executing voluntary recalls. The guidance discusses proper training of personnel, record keeping and recall initiation procedures.

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Regulatory Focus
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FDA
4/24/2019

Johnson & Johnson says that raising the discount on Xarelto to 70% for seniors in the Medicare coverage gap drove sales of the drug lower despite a price hike, but J&J pharmaceuticals chief Jennifer Taubert expects sales to rebound with a new indication for patients with coronary or peripheral artery disease.

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BioPharma Dive
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Johnson & Johnson, Xarelto
4/24/2019

Autolus Therapeutics' AUTO3, which contains enhanced retroviral vector-modified T cells that express two chimeric antigen receptors aimed at CD22 and CD19, was given orphan drug designation by the FDA. The drug is being developed to treat patients with acute lymphoblastic leukemia.

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Seeking Alpha
4/24/2019

Johnson & Johnson will pay $9.9 million to settle a lawsuit alleging failure to disclose serious risks associated with its surgical mesh devices. The suit was brought by Washington Attorney General Bob Ferguson in 2016.

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Johnson & Johnson, Bob Ferguson
4/24/2019

The FDA will hold a meeting May 30 to weigh a higher-risk category for surgical staplers, which have been associated with over 32,000 malfunctions, 9,000 serious injuries and 366 patient deaths since 2011. The agency is looking to reclassify staplers and staples from low-risk to medium-risk.

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FDA
4/24/2019

The FDA has approved Boston Scientific's LOTUS Edge Aortic Valve System for the treatment of patients with severe aortic stenosis who are at high risk for surgery. The system gives physicians the option to reposition and completely recapture the valve once it has been deployed.

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FDA, Boston Scientific, stenosis
4/24/2019

Walgreens Boots Alliance and Rite Aid said they will raise the minimum age for tobacco sales in their stores from 18 to 21, a week after Senate Majority Leader Mitch McConnell, R-Ky., announced plans to introduce a bill that would raise the legal age for purchasing tobacco products. The new policy is expected to take effect in September for Walgreens and within 90 days for Rite Aid.

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Reuters