Biologics are large-molecule drugs produced in living organisms and are used to treat some of the most serious life-threatening diseases.
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Increased blood pressure was observed in rats treated with rHuEpo ().
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Glivec genericization in the US.
Managing chemotherapy-induced anemia with biosimilar epoetin α is consistently cost efficient over treatment with originator epoetin α, epoetin β, and darbepoetin α under both fixed and weight-based dosing scenarios.
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Phase 3 studies were assessed by the FDA and EMA for approval.
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Il est aussi contre-indiqué chez les personnes affectées par une érythroblastopénie ( qui concerne la ) et celles qui ne peuvent pas recevoir un traitement anti-thrombotique.
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A huge part of a brand drug price consists of research and development costs, and advertising.
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Additionally, its oncology drugs are facing competition in the form of immuno-oncology therapies.
For example, the Canadian patent for epoetin alpha expired in May 2014 and epoietin SEBs are expected to enter the Canadian market within the next year.
All this has already been accomplished by the original manufacturer, and was subsequently reflected in the brand-name drug price.
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Medice could not use it as a comparator and conduct the recommended trial (which EMA accepted given the circumstances).
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At least theoretically, in some markets, eg, the US, clinical trials may not be required at all for approval of a biosimilar.
Growth products are an indicator of the rejuvenation of the portfolio, and comprise products launched in a key market (EU, US, Japan) in 2011 or later, or products with exclusivity until at least 2020 in key markets.
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A generic drug manufacturer spends less money on product development and advertising.
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This situation is analogous to the markedly different results obtained using ADA assays of differing sensitivities for detecting anti-adalimumab antibodies in clinical samples.
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But he also will be aiming to dispel notions that the company's growth story will be all about branded drugs.
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Nordic region is founded through its acquisition of Durascan, the generic subsidiary of Astra-Zeneca in Denmark.
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EU shows that the product is subject to additional safety monitoring.
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Our broad portfolio of differentiated generics ranges from advanced application forms such as oral solids, through progressively more complex technologies such as inhalers or injectables to transdermal patches and implants.
The pharmacy you are currently dealing with comes first in the market of delivering and distribution of high-quality medications throughout the world.
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B12 supplements to treat or prevent any medical condition before first consulting your physician.
Excluded from discontinued operations are certain intellectual property rights and related other revenues of the Vaccines Division, which are retained by Novartis and are now reported under Corporate activities.
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NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.
From this point your product is only 8-21 days (depending on the shipping method chosen) from arriving at your home or office.
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The performance benefits of rHuEpo were noted and inappropriate use by some athletes began ().
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SPR (surface plasmon resonance) biosensors are used in drug discovery as tools to provide rich content surrounding the interaction of biomolecules.
The increased serum half-life results in increased in vivo potency because of the extended time the agent can stimulate erythropoiesis.
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In many cases even small changes in the structure of the final molecule can create a different safety and efficacy profile.
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Business: Autoimmune, Biosimilars Biosimilar company Epirus will reverse-merge with Zalicus in a stock deal.
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What Are the Strengths and Weaknesses of the Biosimilars Market in 2013?
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Group (USD 89 million, -4% cc) declined in the first quarter, impacted by temporary supply issues and a higher prior-year base.
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