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4/19/2018

Six health organizations sent a letter to the FDA urging the agency to act to address the rising use of Juul e-cigarettes among teens, while Sen. Dick Durbin, D-Ill., and 10 other senators issued separate letters to Juul Labs and the FDA seeking steps to restrict pediatric use of the e-cigarettes. A survey in the journal Tobacco Control showed that 63% of youths ages 15 to 24 who used Juul were unaware of its nicotine content.

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Juul, Juul, FDA, Sen. Dick Durbin, nicotine
4/19/2018

Medtronic continues to invest in product development amid the rapid pace of innovation in the medtech industry, with its engineers creating leadless versions of more complex devices in hopes of converting all its heart devices to leadless over the coming decades, CEO Omar Ishrak said at a meeting of the Economic Club of Minnesota. The company's long-term plan is to meet the definition of a real "artificial pancreas" for its automated insulin pumps and is also looking to make HeartWare and its other heart pumps fully implantable in the body, Ishrak said.

4/19/2018

AstraZeneca and Daiichi Sankyo introduced in Japan its proton pump inhibitor Nexium, or esomeprazole magnesium hydrate, in 10- and 20-mg granules for suspension, sachet, which is a new formulation of Nexium 10- and 20-mg capsules. The new therapy is indicated for the treatment of gastric, duodenal and anastomotic ulcers; reflux esophagitis; nonerosive reflux disease; Zollinger-Ellison syndrome; inhibition of recurrence of gastric or duodenal ulcer during low-dose aspirin administration; inhibition of recurrence of gastric or duodenal ulcer during nonsteroidal anti-inflammatory drug administration; and support of Helicobacter pylori eradication.

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PharmaBiz (India)
4/19/2018

Chugai Pharmaceutical's Tecentriq, or atezolizumab, intravenous infusion 1,200 mg was launched in Japan as treatment for patients with unresectable advanced or recurrent non-small cell lung cancer.

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PharmaBiz (India)
4/19/2018

Utah-based NGB voluntarily recalled over 1,100 units of NxtGen Botanicals Maeng Da Kratom supplements because they could be contaminated with salmonella, which is linked to at least one illness. The recalled products, which were in sealed bottles sold in 500-mg capsules that have the lot number 171409, were distributed to retailers in Arizona, California, Georgia, Massachusetts, Minnesota and Utah.

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Food Safety News
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salmonella, NGB
4/19/2018

Cantel Medical secured 510(k) clearance from the FDA for its Advantage Plus Pass-Thru automated endoscope reprocessor, a device that provides disinfection for endoscopes. The device, which has the ability to reprocess up to five scopes in over an hour, helps prevent infection by reducing human error through one-way workflow enabled by its pass-through design.

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Cantel Medical, Cantel, FDA
4/19/2018

A follow-on funding pulled in $208 million for MorphoSys, which has plans of filing a rolling biologics license application to the FDA for relapsed or refractory diffuse large B cell lymphoma therapy MOR208 in the second half of 2019.

4/19/2018

The Max Planck Institute of Molecular Physiology agreed to work with AiCuris to discover and develop antibacterial drugs for the treatment of viral and bacterial infections. Under the collaboration, the institute's proprietary collection of natural product-based compounds will be used by AiCuris, and the two will jointly study compounds that have the potential to become anti-infective drugs.

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Max Planck, AiCuris
4/19/2018

The amended Farm Bill, which was recently approved by the House Agriculture Committee, would create a Biotechnology and Agricultural Trade Program to challenge foreign trade barriers that restrict the use of biotech commodities. The bill would also set up a national science-based education campaign to inform the public about the technologies used in food and agricultural production, and would require the Department of Agriculture to report to Congress its plans for improving the regulations on biotech products.

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Agweek
4/19/2018

Japan's government approved a policy that will allow imports of ethyl tert-butyl ether made from US corn ethanol. Under the policy, corn-based ethanol can comprise up to 44% of the country's 217 million-gallon ethanol demand for the production of ETBE, which is used in gasoline as an oxygenate.

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Japan, ETBE