This week’s headlines include, drugs approved in 2013, biosimilar news, crowded cancer drug field, stem cell ALS therapy awaiting Phase II, and patients endorse use of iPSCs.
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“Johnson & Johnson on Wednesday said it submitted a citizen petition asking that U.S. health regulators require copies of biological products to bear names that are similar and not identical to those of their reference products. J&J’s view on naming of biosimilars contrasts that of Mylan Inc and Novartis AG over the past few months, as the U.S. Food and Drug Administration continues to work on drafting regulations for the approval of biosimilars — cheaper versions of expensive biologics, or the original reference drugs.”
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“Santa Claus had no last-minute approvals in his sack, and we ended the year with 27 new drugs (Exhibit 1.). This is a significant drop from the 37 we had last year, and a disappointment to many who had hoped that last year’s surge would be sustained. [Note: this tally excludes 3 imaging agents, but adds back 3 biologicals approved by CBER: Rixubis (nonacog gamma), recombinant factor IX for hemophilia B; NovoEight (turoctocog alfa), recombinant factor VIII for hemophilia A; and FluBlok, recombinant flu vaccine.]”
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“Pharmaceutical companies including Switzerland’s Novartis and Roche are among those developing a treatment for a specific type of lung cancer, a field that is now so crowded it may impact profits. A better understanding of the cause of tumours has drawn resources into cancer research at the expense of antibiotics and cardiovascular disease but over-concentration in certain fields could cut commercial rewards, some analysts say. Both Swiss firms are working on treatments for a specific genetic mutation of metastatic non-small cell lung cancer (NSCLC) called anaplastic lymphoma kinase positive (ALK+), which tends to afflict younger patients and non-smokers.
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“Although induced pluripotent stem cells (iPSCs) are derived without destroying a human embryo, and thereby avoid the most contentious issue besetting Stem Cell Research, they still raise ethical concerns. When asked to voice these concerns, patients raise points about privacy, transparency, consent, the “immortalization” of cell lines, and the commercialization of stem cells. Nonetheless, patients also give iPSC research “broad endorsement,” according to a team of bioethicists at Johns Hopkins University. These bioethics specialists convened several focus groups among patients who had received treatment at Johns Hopkins. These patients indicated that they were largely in favor of participating in iPSC research, even if personal benefit was unlikely. At the same time, however, many participants revealed that they had strong feelings about the ways Stem Cell Research might be conducted, and the uses Stem Cell Research might serve. Patients even suggested that they would weigh these issues when considering whether to participate in Stem Cell Research.”
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“ALS Patient Improves on NurOwn, New Stem Cell Therapy; Company Awaits FDA Decision for Phase II Trial,” Medical Daily
“BrainStorm Cell Therapeutics Inc. announced the results Monday of its most recent research on NurOwn, a new stem cell treatment developed by the company. The Israel-based company reported that an individual diagnosed with both amyotrophic lateral sclerosis (ALS) and myasthenia gravis (MG) showed improvements in cognitive and motor function following initial and repeat treatments with NurOwn. Pending FDA approval, the company plans to begin a phase II clinical trial in the United States in early 2014.”
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“It now takes 10-15 years for a pharmaceutical company to get a new drug approved, and on average the cost exceeds $1 billion. There is a lengthy process of laboratory, animal and clinical studies, and then regulatory review, to establish safety and effectiveness according to government standards. Arguably, that is more than enough. Yet skeptics continue to question the need for many new drugs that make it through the exceedingly rigorous gauntlet. Dr. Marcia Angell, the former editor of the New England Journal of Medicine, has complained for years that most new drugs are only minor variations of old ones, “me-too” drugs, which she has said are “unlikely to be better than existing ones for the same condition.” Drs. Donald Light and Joel Lexchin wrote in 2012 for BMJ (formerly the British Medical Journal) about an “innovation crisis” brought on because “pharmaceutical research and development turns out mostly minor variations on existing drugs.” Rosanne Spector, the editor of Stanford Medicine, similarly charged in 2005 that pharmaceutical companies “chemically rejigger an oldie but goodie, craft a new name, mount a massive advertising campaign and sell the retread as the latest innovative breakthrough.”
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