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7/20/2018

Eli Lilly updated the label for Trulicity, or dulaglutide, to demonstrate the efficacy and safety of the drug in adult patients with type 2 diabetes who have moderate to severe chronic kidney disease. In the AWARD-7 trial, patients achieved comparable glycemic control with weight loss when treated with Trulicity 1.5 mg or 0.75 mg in combination with mealtime insulin lispro, compared with the basal-bolus insulin group.

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Eli Lilly, kidney disease, Trulicity, CKD
7/20/2018

Ocular Therapeutix's resubmitted application for Dextenza, or dexamethasone insert, 0.4 mg was accepted for review by the FDA. The drug is being developed to treat ocular pain caused by ophthalmic surgery.

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Seeking Alpha
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FDA, eye pain, dexamethasone, Dextenza
7/20/2018

Eisai's obesity drug lorcaserin was not associated with an increased risk for major adverse cardiac events, including nonfatal stroke, myocardial infarction and cardiovascular death, according to a postmarketing safety study mandated by the FDA. Researchers evaluated 12,000 overweight and obese patients from the CAMELLIA-TIMI 61 study and also found that taking lorcaserin 10 mg twice daily resulted in a reduced progression to type 2 diabetes among those without the condition at baseline, as well as an improvement in several cardiovascular risk factors, compared with those on placebo.

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lorcaserin, Eisai, FDA
7/20/2018

A number of deregulatory measures to promote the medical device industry have been announced by the South Korean government. The measures include significantly shortening approval periods for new products, adopting a negative regulatory approach for relatively safe products, and simplifying the new medtech assessment procedure for treating patients.

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S. Korea
7/20/2018

The CDC announced that a salmonella reading outbreak linked to raw turkey products has sickened 90 individuals and caused 40 to be admitted to hospitals in 26 states. The CDC has yet to identify the supplier or type of raw turkey product linked to the outbreak.

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Food Safety News
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salmonella, CDC
7/20/2018

An investigation was launched by India's drug controller involving all companies importing valsartan from Chinese manufacturer Zhejiang Huahai Pharmaceutical. Valsartan-containing drugs, often used to treat hypertension, were recently recalled after reports that an ingredient with potential cancer risk was used in valsartan production.

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The Times of India
7/20/2018

Ferring Pharmaceuticals' Zomacton, or somatropin, was approved by the FDA to treat pediatric patients with idiopathic short stature and Turner syndrome-associated short stature. The agency also approved the drug to treat children with short stature or growth failure due to short stature homeobox-containing gene deficiency and short stature in children who were small for gestational age without catch-up growth by age 2 to 4.

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eMPR
7/20/2018

Corbus Pharmaceuticals' dermatomyositis candidate lenabasum was given FDA orphan drug designation.

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Seeking Alpha
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FDA, Corbus Pharmaceuticals, Corbus
7/20/2018

Agilis Biotherapeutics will be acquired by PTC Therapeutics in a deal that will give Agilis an upfront payment of $200 million. Under the terms of the agreement, PTC will acquire Agilis' Phase IIb GT-AADC for severe aromatic L-amino acid decarboxylase deficiency, GT-FA for Friedrich ataxia, GT-AS for Angelman syndrome and a preclinical candidate for the treatment of central nervous system disorders.

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BioCentury
7/20/2018

Novartis was granted exclusive, worldwide rights to midstage MOR106, being developed to treat atopic dermatitis, by MorphoSys and Galapagos. Under the deal, the two firms will get $111.1 million upfront and are eligible for milestone and royalty payments.

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BioCentury
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atopic dermatitis, MorphoSys