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4/26/2017

Sandoz has received backing from the European Medicines Agency's Committee for Medicinal Products for Human Use for approval to market its biosimilars rituximab and etanercept in Europe as a treatment for the same indications as MabThera and Enbrel, respectively.

4/26/2017

The first patient in a postmarket clinical study of the OviTex reinforced bioscaffold for soft-tissue repair has been enrolled by Malvern, Pa.-based Tela Bio. The trial seeks to assess use of the scaffold in 100 patients with ventral hernia and monitor rates of wound-related events, early postoperative surgical site occurrences and other complications in the first three months after surgery.

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TELA Bio
4/26/2017

Data from two subanalyses of a global study presented at the annual Charing Cross Symposium showed positive results for Medtronic's In.Pact Admiral drug-coated balloon for treating peripheral artery disease. The device demonstrated comparable clinically driven target lesion revascularization rates between patients with single lesions of up to 18 cm and those with bilateral/multiple lesions and moderate to severe calcification, and an 88.8% primary patency rate in patients with complex, calcified lesions.

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Medtronic
4/25/2017

For the past 6 years, our publisher Brian Johnson has interviewed the most successful men and women in the medical device industry at our DeviceTalks events. Over time, he's discovered a commonality of traits. For example, former Stryker CEO John Brown hates to lose -- a sentiment many others express. Top executives including former Medtronic CEO Bill Hawkins are adept at finding their way around obstacles. And leaders such as Boston Scientific CEO Michael Mahoney know how to take culture seriously. Discover more at DeviceTalks Minnesota, June 26-27. Read the story.

4/25/2017

The Senate Committee on Health, Education, Labor and Pensions is scheduled to vote Wednesday on the nomination of Scott Gottlieb to serve as FDA commissioner, and the committee is expected to approve the nomination.

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The Hill
4/25/2017

Ghana, Kenya and Malawi will offer GlaxoSmithKline's injectable malaria vaccine, Mosquirix, for babies and children in high-risk areas starting in 2018, according to the World Health Organization, which will use the results of the pilot program as a basis for recommending the vaccine. The PATH Malaria Vaccine Initiative and the Bill & Melinda Gates Foundation worked with GSK to develop the vaccine, and the pilot study is being funded by Gavi, the Vaccine Alliance, UNITAID and the Global Fund to Fight AIDS, Tuberculosis and Malaria.

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Reuters
4/25/2017

European regulators have given Synaptive Medical CE mark approval for its BrightMatter Plan neurosurgical planning system, which enables automatic generation of 3D images of the brain using diffusion tensor imaging. The technology also has been approved by regulators in Australia.

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Synaptive Medical
4/25/2017

Sanofi's Thymoglobulin has been approved by the FDA as a treatment to be used in conjunction with concomitant immunosuppression for the prevention of acute kidney transplant rejection in patients.

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Reuters
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immunosuppression, Thymoglobulin
4/25/2017

The FDA has approved the investigational new drug application filed by AnGes for its clinical trial of F-kappaB decoy oligo DNA as a treatment for discogenic lower back pain.

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Reuters
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FDA
4/25/2017

Pooled results from two late-stage trials of Adamas Pharmaceuticals' ADS-5102, or amantadine, showed that the drug produced a statistically significant reduction in "off time" and a significant reduction in dyskinesia associated with levodopa in patients with Parkinson's disease.