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FDA accepts Roche’s supplemental biologics license application for Tecentriq plus chemotherapy for initial treatment of metastatic non-squamous non-small cell lung cancer

Roche announced that the U.S. Food and Drug Administration accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq in combination with Abraxane and carboplatin for the initial treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumor aberrations.

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House Oversight Committee Takes on Pharma Industry

The House Committee on Oversight and Reform launched an investigation into prescription drug pricing practices.

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Merck’s Keytruda Cuts Death Risk by 31 Percent in Esophageal Cancer

Merck & Co. released data from KEYNOTE-181, a Phase III trial of Keytruda as a monotherapy for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma.

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Novartis migraine drug not cost effective – UK price watchdog

Britain’s drug price watchdog rejected Novartis’ migraine drug Aimovig for now, concluding in a draft decision that the medicine was not a cost-effective use of National Health Service resources.

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Sen. Sanders, Rep. Cummings to introduce bill to lower U.S. drug prices

U.S. Senator Bernie Sanders and Representative Elijah Cummings plan to introduce legislation aimed at lowering the cost of prescription drugs for U.S. consumers.

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Drug companies greet 2019 with U.S. price hikes

Drugmakers kicked off 2019 with price increases in the United States on more than 250 prescription drugs, including the world’s top-selling medicine Humira, although the pace of price hikes was slower than during 2018.

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Aurobindo Pharma to recall 80 lots of blood pressure medicine valsartan in the US

A U.S. unit of Indian generic drugmaker Aurobindo Pharma Ltd. will recall 80 lots of medicines containing the blood pressure drug valsartan that were found to have a probable cancer-causing impurity, according to the U.S. Food and Drug Administration.

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7 Biotech Trends to Look Out for in 2019

Here are seven trends most likely to be hitting the news cycle in 2019 according to BioSpace.

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BioSpace Readers’ Picks: Top 10 Stories of 2018

Here is a look at BioSpace’s top 10 stories of 2018.

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U.S. body says gene therapy may be more cost effective for spinal muscular atrophy

Biogen Inc.’s Spinraza treatment for spinal muscular atrophy and Swiss drugmaker Novartis AG’s experimental gene therapy are both expensive, but the gene therapy could be more cost effective once more is known about its U.S. price and long-term success rates, a preliminary report from an independent U.S. nonprofit organization said.

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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!

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