Life Sciences
Top stories summarized by our editors
5/23/2018

House lawmakers approved legislation Tuesday that would allow terminally ill patients to request access to experimental drugs that have undergone early-stage clinical trials but have yet to receive approval from the FDA. The bill, which would not require pharmaceutical companies to provide the drugs, was passed by the Senate last year and now goes to President Donald Trump for his expected signature.

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House
5/23/2018

Revibe of Missouri, Colorado-based Front Range Kratom and Kratom Spot of California received warning letters from the FDA about selling kratom-containing, illegal, unapproved products, which the firms claim could treat opioid addiction and withdrawal, pain and cancer, as well as lower blood pressure and lessen neuron damage caused by stroke. The agency determined that kratom, which is listed as a "drug and chemical of concern" by the Drug Enforcement Administration, has similar effects to narcotics and has led to dozens of deaths.

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Reuters
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FDA
5/23/2018

The FDA issued warning letters to companies selling dietary supplement pills and capsules, such as Solaricare, Sunsafe Rx, Sunergetic and Advanced Skin Brightening Formula, which claim to protect against the sun. FDA Commissioner Scott Gottlieb said any ingestible sun protection product would be considered a drug, and the FDA has not approved a drug with that claim.

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USA Today
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Commissioner Scott Gottlieb
5/23/2018

Sanofi's marketing application for Zynquista, or sotagliflozin, was accepted by the FDA for review. The drug is used as an add-on to insulin to help adult patients with type 1 diabetes achieve better blood sugar control.

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Seeking Alpha
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Sanofi, Zynquista
5/23/2018

Eli Lilly's and Co.'s Taltz, or ixekizumab, is the first medication for moderate to severe plaque psoriasis to receive FDA approval to include on its label data on psoriasis involving the genital area. The drug was previously approved as a treatment for patients with psoriatic arthritis and plaque psoriasis.

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Seeking Alpha
5/23/2018

FDA Commissioner Scott Gottlieb is paving the way for drug developers to advance more gene therapies for various diseases by creating a framework that will guide gene therapy manufacturers. "The first therapeutic area we'll focus on is hemophilia, where factor production may be sufficient in some cases as a surrogate measure of benefit where a gene therapy product can potentially normalize factor production," Gottlieb said.

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BioCentury, Endpoints News
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Commissioner Scott Gottlieb, FDA
5/23/2018

Mumbai, India-based Sun Pharmaceutical was granted approval by the FDA for its Yonsa, or abiraterone acetate, in combination with methylprednisolone to treat patients with metastatic castration-resistant prostate cancer. The drug will be marketed as a branded therapy.

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PharmaBiz (India)
5/23/2018

The Department of Justice filed a civil complaint in the US District Court for the Eastern District of New York on behalf of the FDA, seeking to permanently enjoin Royal Seafood Baza and Euroline Foods for violating the Federal Food, Drug and Cosmetic Act for processing and distributing food in unsanitary conditions. The complaint says the companies, which process and distribute ready-to-eat fish, fishery products, cheese products and vegetable salads in a Staten Island, N.Y., facility that was contaminated with Listeria monocytogenes, failed to adequately implement effective sanitation controls to reduce the risk of such health hazards and comply with Current Good Manufacturing Practices requirements.

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Food Safety News
5/23/2018

The Global Unite reverse fracture shoulder implant was released by Johnson & Johnson subsidiary DePuy Synthes for use in post-complex fracture shoulder reconstruction procedures in patients with grossly deficient rotator cuffs. The system, which comes with a Porocoat porous coating and numerous suture holes and pockets for better bone fixation around the implant, is designed to improve flexibility for secure reattachment of the bone to the implant.

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MassDevice (Boston)
5/23/2018

The FDA granted Providence Medical Technology 510(k) clearance for its DTRAX spinal system, a device intended to facilitate posterior cervical fusion in patients who have cervical degenerative disease.