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9/25/2018

The FDA granted accelerated approval for Verastem Oncology's Copiktra, or duvelisib, as a treatment for adult patients with small lymphocytic lymphoma or relapsed/refractory follicular lymphoma or chronic lymphocytic leukemia following two or more lines of therapy.

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Seeking Alpha
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Lymphoma, FDA, Verastem
9/25/2018

Medtronic and Johnson & Johnson remain the world's largest medical device companies. But after that, the roster is radically shifting amid a slew of mergers and acquisitions. In some cases such as GE, Philips and Siemens, major multinationals are breaking apart. We've sifted through data from public companies' annual reports and other publicly disclosed information -- all to create our annual Big 100 list of the world's major medtech companies. Go to Medical Design & Outsourcing to find out more.

9/25/2018

An analysis from The Associated Press found that drugmakers implemented more drug price hikes than cuts from January through July despite the Trump administration's campaign to lower drug prices. There were 4,412 price hikes and 46 cuts during the period, but there were fewer increases than in previous years and the median increase was smaller than in 2017, though the median price cut was also smaller than in prior years.

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The Associated Press
9/25/2018

A startup that has the world's biggest human microbiome database, uBiome, raised $83 million in its most recent funding round. CEO Jessica Richman says the capital will fund several initiatives, including patent asset development and drug discovery.

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Compelo
9/25/2018

House and Senate lawmakers finalized a major opioid legislative package late Monday, and it won't include a technical change to Medicare Part D's "doughnut hole" language pushed by pharmaceutical firms. The final package includes a measure by Sen. Rob Portman, R-Ohio, that would temporarily lift restrictions on use of Medicaid funds for inpatient addiction treatment.

9/25/2018

Gilead Sciences said it will launch generic versions of its blockbuster hepatitis C drugs Epclusa and Harvoni in January through a new subsidiary called Asegua Therapeutics. The authorized generics will cost $24,000 per treatment course, well below the launch prices of Harvoni and Epclusa, which were $94,500 and $74,760, respectively.

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Gilead Sciences, Harvoni
9/25/2018

Patients with atrial fibrillation who take clot-preventing pills daily experienced fewer strokes, based on data published in the journal Stroke from a study that compared a group taking Coumadin, or warfarin, and those taking newer oral anticoagulants. The annual stroke rate for the group taking warfarin was 2.1 for every 100,000 patients compared with the annual stroke rate of 1.17 for every 100,000 patients among those taking NOACs.

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Reuters
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warfarin
9/25/2018

Pierre Fabre's Braftovi, or encorafenib, in combination with Mektovi, or binimetinib, was approved by the European Commission for adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The decision was backed by data from the late-stage COLUMBUS trial, in which treatment with the combination led to 14.9 months of median progression-free survival, compared with 7.3 months with vemurafenib as monotherapy.

9/25/2018

Leica Microsystems has secured clearance from the FDA to market its augmented reality GLOW800 surgical fluorescence for vascular neurosurgery. The technology, which is used with indocyanine green, enables cerebral anatomy to be viewed in natural color, along with vascular flow in real time.

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FDA, AR
9/25/2018

The USDA's Food Safety and Inspection Service released a list retailers that received Cargill Meat Solutions' 66 tons of ground beef that were contaminated with Escherichia coli O26. The list includes all Safeway, Meijer and Sam's Club stores in the US, as well as multiple Target stores.

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Food Safety News