Celgene reports primary endpoint achieved by multiple myeloma drug combo | PDUFA date for Salix's Plenvu extended by FDA | Study tests hantavirus vaccine on military patients
February 12, 2018
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Celgene reports primary endpoint achieved by multiple myeloma drug combo
Data show the pivotal late-stage trial to test the efficacy of the triple drug combo regimen consisting of Pomalyst, or pomalidomide, Velcade, or bortezomib, and low-dose dexamethasone was able to achieve its primary endpoint against treatment-resistant multiple myeloma, according to Celgene.
Endpoints News (2/6) 
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Health Care & Policy
PDUFA date for Salix's Plenvu extended by FDA
The action date for Salix Pharmaceuticals' marketing application for Plenvu was moved by the FDA to May 13 because the agency needs more time to evaluate additional data the company submitted. The drug is being assessed for bowel cleansing.
Seeking Alpha (free registration) (2/9) 
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Study tests hantavirus vaccine on military patients
South Korean military personnel benefited slightly from an inactivated hantavirus vaccine, which was moderately effective in providing protection against hemorrhagic fever with renal syndrome, or HFRS, according to findings published in the Journal of Infectious Diseases. The vaccine was given to military personnel in divisions or battalions in which HFRS was reported within the past three years.
Healio (free registration) (2/11) 
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Catalyst Bio reports on preliminary results for hemophilia B candidate
Catalyst Biosciences unveiled details from its early-stage trial to assess the efficacy of its hemophilia B candidate CB 2679d/ISU304 through subcutaneous administration, which showed a linear increase in factor IX levels after six days of dosing, according to topline data presented at the European Association for Hemophilia and Allied Disorders Annual Congress. Continued dosing could achieve more clinically significant results, Catalyst said.
Seeking Alpha (free registration) (2/9) 
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Roche's follicular lymphoma drug gains NICE backing
The UK's National Institute for Health and Care Excellence now recommends the use of Roche Holding's Gazyvaro, or obinutuzumab, for previously untreated patients with advanced follicular lymphoma. NICE rejected the drug, which is also called Gazyva, last year as a first-line treatment because of its high cost, but Roche revised its cost-benefit analysis by targeting higher-risk lymphoma patients.
Seeking Alpha (free registration) (2/9),  Reuters (2/9) 
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EU approves Novo's type 2 diabetes drug
Novo Nordisk was granted approval by European regulators for its Ozempic, or semaglutide, type 2 diabetes treatment for use in a multidose pen. The company plans to file a variation application with the European Medicines Agency for an updated Ozempic pen offering.
Reuters (2/9) 
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Company & Financial News
Financing round brings in $55M for InnoCare
A financing round raised $55 million for InnoCare Pharma. The company is conducting research and development and in-licensing a pipeline of immune-modulating therapies for cancer and autoimmune diseases, including its candidate IPC-022, which is undergoing clinical testing.
BioCentury (2/9) 
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BioPorto enters distribution deal with Roche for NGAL test
Denmark-based in vitro diagnostics company BioPorto signed an agreement with Roche Holding to globally distribute its CE-marked neutrophil gelatinase-associated lipocalin test for use on Cobas c 502 and Cobas c 501 analyzers to diagnose acute kidney injury; terms were undisclosed. Clinical studies are being conducted by BioPorto as it expects to receive FDA approval for the test later this year.
360Dx (tiered subscription model)/GenomeWeb Daily News (2/9) 
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Food & Agriculture
Nigeria to commercialize biotech seeds
Nigeria's National Biosafety Management Agency, established by its Biosafety Bill, said the country is ready to commercialize certain biotech staple crops after the satisfactory completion of confined field trials. Those crops include cowpea, rice, sorghum, corn and cotton.
Leadership Nigeria (2/6) 
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Industrial & Environmental
Companies search for plant-based alternatives to plastic
Researchers at Biome Bioplastics and other companies are working on a plant-based material and other alternatives that could serve as a compostable, recyclable alternative to petroleum-based plastics. More than 5 trillion pieces of plastic waste are estimated to be floating in the world's oceans, the BBC reports.
BBC (2/9) 
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The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com.
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