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9/21/2018

Oral flea and tick preventives containing isoxazoline can cause seizures, ataxia, muscle tremors or other neurological problems, and product labels should be updated, the FDA said. The agency said the products have been carefully reviewed and "continue to be safe and effective for the majority of animals."

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NBC News
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FDA
9/21/2018

Cargill Meat Solutions issued a recall for 66.3 tons of ground beef produced at the company's Fort Morgan, Colo., facility after a four-state E. coli O26 outbreak sickened 18 people, including one person who died and six who were hospitalized. The recalled products were fine grind beef products, which bear the establishment number EST. 86R and were distributed to retail locations across the US.

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Food Safety News
9/21/2018

HHS said the Trump administration is working with California-based drugmaker Opiant Pharmaceuticals to develop a nasal spray opioid overdose antidote called nalmefene that can be used to prevent opioid-related deaths and protect against the threat of fentanyl being used in a terrorist attack. An injector version of the drug was approved by the FDA, but it was pulled from the market in 2008 due to low sales.

9/21/2018

The Australian Therapeutic Goods Administration approved Sun Pharmaceutical Industries' Ilumya, or tildrakizumab, as a treatment for adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy. The decision was backed by data from a late-stage trial, in which patients who were treated with Ilumya showed significant clinical improvement versus placebo or etanercept use.

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PharmaBiz (India)
9/21/2018

Inui Health has secured clearance from the FDA to market its smartphone system for urine testing for detection of diabetes, urinary tract infection, kidney problems, pregestational diabetes and preeclampsia.

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FDAnews
9/21/2018

An initial public offering pulled in $96 million for cancer biotech company Y-mAbs Therapeutics. The company intends to file biologics license applications for two pediatric neuroblastoma candidates that both already have orphan drug, rare pediatric disease and breakthrough therapy designations.

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BioCentury
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Y-mAbs Therapeutics
9/21/2018

Daiichi Sankyo and a subsidiary of Merck, known as MSD outside North America, agreed to work together to develop the former's DS-8201 in combination with the latter's Keytruda as a treatment for patients with breast or lung cancers. Daiichi will conduct a two-part Phase Ib safety and efficacy study of the combination drug in patients with HER2-expressing or HER2 mutant advanced/metastatic non-small cell lung cancer and patients with HER2-expressing advanced/metastatic breast cancer.

9/21/2018

Astellas Pharma announced that the key endpoints were met for its Phase III study to evaluate its candidate roxadustat as a treatment for patients with chronic kidney disease and anemia who were not undergoing dialysis. Data showed that the drug was superior in efficacy compared to placebo based on hemoglobin response rate during the first 24 weeks and changes in baseline hemoglobin from weeks 28 to 52.

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Astellas Pharma
9/21/2018

The FDA granted breakthrough therapy designation to Pfizer's 20-valent pneumococcal conjugate vaccine candidate PF-06482077, which is being developed to prevent invasive disease and pneumonia brought on by Streptococcus pneumoniae serotypes in adults. The company plans to launch late-stage studies in the next few months.

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Seeking Alpha
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Pfizer, pneumonia, FDA
9/21/2018

The FDA issued a complete response letter to Pharming Group regarding its supplemental biologics license application for Ruconest, or C1 esterase inhibitor (recombinant), to be used as a prophylaxis in patients with hereditary angioedema. Pharming said it hopes to work with the FDA to generate more data required by the agency to use the drug for the indication.

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PharmaBiz (India)