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Home » Topics » Regulatory

Regulatory
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Latest telehealth bill would dismantle some geographic restrictions

Nov. 11, 2019
By Mark McCarty
Advocates of telehealth are backing the bipartisan, bicameral Connect for Health Act of 2019, which would eliminate geographic and origination site restrictions on Medicare coverage and save billions of taxpayer dollars.
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Acceleron's Celgene-partnered luspatercept wins FDA nod in beta-thalassemia

Nov. 10, 2019
By Jennifer Boggs
Nearly a month ahead of the PDUFA date, red blood cell maturation drug luspatercept cleared the FDA for treating anemia in adults with beta-thalassemia who require regular red blood cell (RBC) transfusions. Branded Reblozyl, the drug, developed in a collaboration between Celgene Corp. and Acceleron Pharma Inc., is expected to be available in one week following approval.
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FDA sign

People problems cited as the root of most duodenoscope issues

Nov. 8, 2019
By Mark McCarty
The U.S. FDA's two-day advisory hearing on industrial ethylene oxide (EtO) sterilization of medical devices wrapped up with a discussion of how duodenoscopes can be made safer. The conclusion was largely that employee churn, training and work conditions were the biggest challenges – issues over which the FDA has nearly zero leverage.
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Regulatory front for Nov. 8, 2019

Nov. 8, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Green traffic light

Bio-Thera wins first Humira biosimilar approval in China

Nov. 8, 2019
By Elise Mak
BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, said its BAT-1406 became the first biosimilar referencing Abbvie Inc.'s blockbuster TNF-blocker, Humira (adalimumab), to win a marketing nod in China. It is Bio-Thera's first biosimilar and China's second homegrown biosimilar approved by the National Medical Products Administration (NMPA).
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FDA panel says tweaks are the best short-term answer to EtO controversy

Nov. 7, 2019
By Mark McCarty
The first day of the FDA's two-day hearing on ethylene oxide (EtO) sterilization of medical devices addressed several alternatives to EtO, but the advisory panel had little advice to offer the agency other than to encourage tweaks to sterilization procedures in order to get past the immediate problem.
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Nevro-Corp-Omnia-11-7.png

Nevro aims to dominate SCS with first system to deliver all frequencies

Nov. 7, 2019
By Stacy Lawrence
The U.S. FDA has approved the Senza Omnia Spinal Cord Stimulation (SCS) system from Redwood City, Calif.-based Nevro Corp. The system is the first such system that delivers Nevro's high frequency 10,000 Hz stimulation, known as HF10, but also all other therapeutic spinal cord stimulation frequencies.
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DNA illustration

FDA authorizes first NGS test to detect critical HIV-1 drug resistance mutations

Nov. 7, 2019
By Meg Bryant
Singapore-based Vela Diagnostics Holding Pte. Ltd. has received U.S. FDA authorization via the de novo approval pathway for an in vitro diagnostic test to detect HIV-1 genomic drug resistance mutations (DRMs). The Sentosa SQ HIV-1 Genotyping Assay – the first HIV-1 genotyping next-generation sequencing (NGS) assay to win an FDA nod – uses plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase and integrase regions of the pol gene in a single test.
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Regulatory front for Nov. 7, 2019

Nov. 7, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Globe showing China

China grants conditional approval to Green Valley's GV-971 for Alzheimer's disease

Nov. 6, 2019
By Elise Mak
BEIJING – Chinese drug regulators granted conditional approval to Shanghai Green Valley (Group) Co. Ltd.'s marine-derived oligosaccharide, GV-971, to treat Alzheimer's disease (AD), but required further trials to prove the drug's efficacy after marketing.
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