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Oklahoma sues opioid drugmakers; New Hampshire presses epidemic probe

Oklahoma joined growing litigation over claims drugmakers misrepresented the risks of opioid painkillers, as New Hampshire cleared a hurdle in its own probe of the role played by companies in the national addiction epidemic.

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FDA Grants Priority Review to HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab

The U.S. FDA accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1).

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BioMarin Submits Pegvaliase Biologics License Application to the U.S. FDA for Treatment of Phenylketonuria

BioMarin Pharmaceutical Inc. announced that the company submitted a Biologics License Application on June 30, 2017 to the U.S. Food and Drug Administration for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, to reduce blood phenylalanine (Phe) levels in adult patients with PKU who have uncontrolled blood Phe levels on existing management.

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Roche buys diabetes app firm

Roche bought Vienna-based diabetes management platform mySugr, joining a crowd of companies expanding app-based digital health services.

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Pfizer’s Besponsa Approved in EU

The European Commission approved Besponsa as monotherapy for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

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Shire to Consolidate 3,000+ Jobs Over 4 Years to 2 Massachusetts Sites

Dublin, Ireland-based Shire plans to consolidate more than 3,000 staffers spread out at over half-a-dozen locations across Massachusetts to two campuses in Cambridge and Lexington.

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7 determining approaches for picking the perfect service

Presently, if to think about the broad choice of the ventures, it is not complicated to confuse. All the online services possess various odds and it is not easy to decide on one Alternative data-warehousing system. As it happens, we passed a resolution to give you approaches about the details which you are bound to […]

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FDA Approves Vectibix For Use In Wild-Type RAS Metastatic Colorectal Cancer

Amgen announced that the U.S. FDA approved the supplemental Biologics License Application for Vectibix (panitumumab) for patients with wild-type RAS metastatic colorectal cancer.

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Acorda Submits New Drug Application to U.S. Food and Drug Administration for Inbrija (CVT-301, Levodopa Inhalation Powder)

Acorda Therapeutics Inc. submitted a New Drug Application to the U.S. Food and Drug Administration for Inbrija (CVT-301, levodopa inhalation powder). Acorda is developing Inbrija as a treatment for symptoms of OFF periods in people with Parkinson’s taking a carbidopa/levodopa regimen. OFF periods refer to the re-emergence of Parkinson’s symptoms. The trade name for CVT-301, Inbrija, has been conditionally accepted by the FDA.

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First Scientifically Validated Symptom Checker with Artificial Intelligence Launches in the United States

Mediktor, a European health technology company, announced the U.S. launch of the first scientifically validated health checker based on artificial intelligence.

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Senate Majority leader cites ‘good progress’ on healthcare talks

U.S. Senate Majority Leader Mitch McConnell said Republican senators are making “good progress” on their efforts to come to agreement on retooled draft legislation aimed at repealing and replacing the 2010 Affordable Care Act.

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FDA Unveils Orphan Drug Modernization Plan

FDA plans to reorganize its drug review staff and create a SWAT team to eliminate a backlog of drugs for rare diseases and speed reviews of future applications.

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FDA Approves VNS Therapy Treatment

FDA approved LivaNova’s VNS Therapy system in patients as young as 4 years of age with partial-onset seizures that are refractory to antiepileptic medications.

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Celltrion and Teva Announce U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar to Rituxan

Celltrion Inc. and Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration accepted for review the Biologics License Application for CT-P10, a proposed Monoclonal Antibody (mAb) biosimilar to Rituxan (rituximab), which is used to treat patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

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Roche to Slash 75 Jobs in Massachusetts, More Consolidation to Come

Switzerland-based Roche AG is tweaking its operations. The latest is an announcement that the company plans to eliminate 75 jobs in central Massachusetts.

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Five Biotechs Awaiting Big News From the FDA in July 2017

A decision by the U.S. Food and Drug Administration can be a big boost – or a big negative – for biotech stocks. Keith Speights, writing for The Motley Fool, analyzes five biotech companies facing FDA decisions in July 2017.

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AstraZeneca, Chi-Med take kidney cancer drug into final testing

AstraZeneca and Hutchison China MediTech said they had initiated a global late-stage clinical trial of the experimental drug savolitinib in a relatively rare type of kidney cancer.

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Intouch Solutions expands NYC team with agency veterans

Intouch Solutions announced the recent hires of Kim Middleton, senior vice president of client services, and Marc Sirockman, vice president of strategic development.

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Pfizer Expects to Hire 80 New Staffers After Completion of $200 Million R&D Facility

Pfizer plans to hire about 80 new staffers when the company completes construction of its new research-and-development campus in Chesterfield, Missouri.

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