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11/20/2017

The European Centre for Disease Prevention and Control reports that antimicrobial resistance is increasing in 30 countries in the European Union and European Economic Area, particularly for Escherichia coli and the Acinetobacter species. A significant decrease, however, was seen in rates of methicillin resistance among Staphylococcus aureus from 2013 to 2016.

11/20/2017

Glenmark Pharmaceuticals' Hailey 24 Fe, or norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets, in 1 mg/20 mcg was granted approval by the US FDA. The drug is a generic version of Allergan Pharmaceuticals' Loestrin 24 Fe tablets.

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PharmaBiz (India)
11/17/2017

Pfizer's Sutent, or sunitinib malate, was approved by the FDA as an adjuvant treatment for renal cell carcinoma in adult patients who are at high risk for disease recurrence after a kidney has been removed. The labeling for Sutent contains a boxed warning regarding the risk for severe liver damage.

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Sutent, Pfizer, kidney cancer, FDA
11/17/2017

Dueling trademark infringement lawsuits were filed by dietary supplement distributors Peak Wellness Nutrition and Peak Wellness Biopharma against each other in the US District Court for the Southern District of Florida and the US District Court in New Haven, Conn. PWN argues that PWB abandoned its mark in 2011 and PWN began using the mark in 2013, while PWB is accusing PWN of trademark infringement, unfair competition and violating the Connecticut Unfair Trade Practices Act, arguing it is selling supplements to customers who believe the products are coming from PWB.

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US District Court
11/17/2017

A guidance on direct marking of medical devices with a unique device identifier was finalized by the FDA. The document explains when direct marking with a UDI is required, provides clarification on the criteria for exceptions to direct marking requirements, presents the agency's interpretation of certain terms and offers recommendations on how to comply with the requirements.

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Regulatory Focus
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FDA
11/17/2017

HHS should ensure the cybersecurity of medical devices by requiring manufacturers to provide a list of third-party software components in each device, House Energy and Commerce Committee Chairman Greg Walden, R-Ore., wrote in a letter to HHS on behalf of the committee. The letter also called for a plan for coordinating stakeholders to create a framework for this proposed requirement and said it should be developed by Dec. 15.

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The Hill
11/17/2017

Varian Medical's Halcyon image-guided volumetric intensity modulated radiotherapy cancer treatment system was granted Shonin approval by the Japanese Ministry of Health, Labor and Welfare. The system comes with enhancements that improve comfort for patients and streamline workflow of the operator, reducing the number of steps from start to treatment from 30 in legacy machines to nine.

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MassDevice (Boston)
11/17/2017

Roche Holding was granted approval by the FDA for its Hemlibra, or emicizumab-kxwh, as a treatment for adult and pediatric patients with hemophilia A who have factor VIII inhibitors. The once-weekly administered drug, given via subcutaneous injection, is a preventive treatment for bleeding episodes in patients.

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Roche
11/17/2017

Bluebird bio's Phase III trial to assess its lead candidate, LentiGlobin, in transfusion-dependent beta-thalassemia patients with the β0/β0 genotype was initiated with the dosing of its first participant. The study's main goal is to attain a certain percentage of patients who achieve at least a 60% reduction in the volume of red blood cell transfusion requirements from year one to year two with treatment compared with transfusion requirements two years before dosing.

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beta-thalassemia
11/17/2017

Takeda received an endorsement from the Committee for Medicinal Products for Human Use to expand the use of Adcetris, or brentuximab vedotin, as a second-line treatment for adult patients with CD30-positive cutaneous T-cell lymphoma. The drug is currently approved as a treatment for relapsed or refractory systemic anaplastic large cell lymphoma or relapsed or refractory CD30-positive Hodgkin lymphoma after autologous stem cell transplant or after at least two therapies when ASCT or multiagent chemotherapy cannot be used.

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PharmaTimes (U.K.)
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Takeda, EU