Biotechnology news

• Novo Nordisk Wins FDA Panel Recommendation for Once-Weekly Diabetes Candidate Semaglutide

  19-10-2017 16:33
  Novo Nordisk is on track to win FDA approval later this year to market the first once-weekly type 2 diabetes treatment following an advisory committee’s unanimous recommendation yesterday in favor of the company’s semaglutide.The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 16 to 0, with one abstention, to recommend approval of Novo Nordisk’s semaglutide, concluding that the glycemic control injection treatment was safe and effective.The FDA u
  
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• Skin Cancer Starts When Tanning Goes Wrong in Mutated Stem Cells

  19-10-2017 16:30
  The origin of melanoma, one of the deadliest cancers, precedes the usual warning signs—the appearance of new or changing skin lesions. Melanoma actually begins in individual cells, most often in cells located in clear skin. But exactly which cells, under what circumstances, has been unclear. But now, reports a group of scientists based at Cornell University, melanoma may arise from melanocyte stem cells (MCSCs), specifically, MCSCs that have become “melanoma competent” because
  
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• FDA Approves Gilead CAR-T Therapy Yescarta, Plans Regenerative Medicine Policy 'Soon'

  19-10-2017 15:34
  Gilead Sciences’ Kite subsidiary has won FDA approval for Yescarta™ (axicabtagene ciloleucel), the second time in less than two months that the agency has authorized a chimeric antigen receptor T-cell (CAR-T) treatment for a form of cancer.As with the first-approved CAR-T therapy , Novartis’ Kymriah (tisagenlecleucel), the FDA acted more than a month ahead of schedule. The agency had set a Prescription Drug User Fee Act (PDUFA) target decision date for Yescarta of November 29,
  
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• Breast Cancer Recycles Toxic Waste to Restock Nitrogen for Growth

  19-10-2017 14:46
  Scientists may have hit upon a new therapeutic strategy against breast cancer with the finding that breast tumor cells recycle the ammonia that is generated as a byproduct of normal cell metabolism  and use the toxic waste as a source of nitrogen to fuel their growth. The studies, by researchers at Harvard Medical School (HMS) and the Broad Institute of MIT and Harvard, showed that while cultured breast cancer cells proliferated and thrived in the presence of ammonia, inhibiting ammonia met
  
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• Blaming Pharma Won’t Lower Health Care Costs

  19-10-2017 14:00
  This week, the USA Today Editorial Board took aim at the pharmaceutical industry in a new piece: Stop Big Pharma from ‘getting away with murder’. After digging into the data, we found several factual inaccuracies that must addressed. Let’s take a look:
  First, the editorial falsely claims that prescription drug costs for individuals under the age of 65 are expected to rise by 11.6%. But the authors of the study cited by the Editorial Board note that this number do
  
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• Novel Parkinson’s Therapy Suggested by New Research Findings

  19-10-2017 13:52
  An international scientific team reports that they have shed light on the molecular mechanism underlying Parkinson's protein LRRK2. The group, which found a direct link between the protein's dimerization and mutations that lead to Parkinson's disease, believes their work could eventually lead to new therapies for this devastating disease. They report the results of their research (“A homologue of the Parkinson’s disease-associated protein LRRK2 undergoes a monomer-dimer transition du
  
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• “Diverse Candidates Can Win If They Can Get the Interview.”

  19-10-2017 00:56
  Diversity is gaining more attention among biotech investors and companies alike. At entry level, 50% of workers are female, but by the functional leader stage, that number tapers off to 30% and continues to fall to 16% at the CEO level. Ethnic representation in executive roles is just as bleak. As an industry, leadership that is more reflective of the people it serves will drive innovation and produce better business results. The #BIF17 Business Panel, “Practical Approaches for I
  
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• #BIF17: Looking Ahead to 2018 Policy Landscape

  19-10-2017 00:13
  The past year has seen a number of important changes in the legislative and policy landscape for biopharmaceutical companies of all sizes: Passage of the 21st Century Cures Act in December and PDUFA VI as part of the FDA Reauthorization Act (FDARA) in August, as well as the confirmation of Dr. Scott Gottlieb as FDA Commissioner, who has set an ambitious agenda for the agency. Continued talks on Capitol Hill on how best to fix the health insurance markets, and wider discussions about how to move
  
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