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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Sandoz launches Phase III clinical trial for biosimilar etanercept
Etanercept
is made from the combination of two naturally occurring soluble human 75-kilodalton TNF receptors linked to an Fc portion of an IgG1. The effect is an artificially engineered dimeric fusion protein.
• Sandoz continues to advance biosimilar pipeline with seven Phase III trials across five molecules
• Global program underscores Sandoz’s leadership in biosimilarsHolzkirchen, Germany, June 24, 2013 – Sandoz, the global leader in biosimilars, announced it has initiated a major Phase III clinical trial with its biosimilar version of etanercept (Amgen’s Enbrel®).
Read more at
http://www.drugs.com/news/novartis-begins-enbrel-phase-iii-trial-45414.html
| Etanercept (trade name Enbrel) is a biopharmaceutical that treats autoimmune diseases by interfering with tumor necrosis factor (TNF; a soluble inflammatory cytokine) by acting as a TNF inhibitor. It has U.S. F.D.A. approval to treat rheumatoid, juvenile rheumatoid andpsoriatic arthritis, plaque psoriasis and ankylosing spondylitis. TNF-alpha is the “master regulator” of the inflammatory (immune) response in many organ systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF-alpha. Etanercept is a fusion protein produced by recombinant DNA. It fuses the TNF receptor to the constant end of the IgG1 antibody. First, the developers isolated the DNA sequence that codes the human gene for soluble TNF receptor 2, which is a receptor that binds to tumor necrosis factor-alpha. Second, they isolated the DNA sequence that codes the human gene for the Fc end of immunoglobulin G1 (IgG1). Third, they linked the DNA for TNF receptor 2 to the DNA for IgG1 Fc. Finally, they expressed the linked DNA to produce a protein that links the protein for TNF receptor 2 to the protein for IgG1 Fc. The prototypic fusion protein was first synthesized and shown to be highly active and unusually stable as a modality for blockade of TNF in vivo in the early 1990s by Bruce A. Beutler, an academic researcher then at the University of Texas Southwestern Medical Center at Dallas, and his colleagues.[2][3][4] These investigators also patented the protein, selling all rights to its use to Immunex, a biotechnology company that was acquired by Amgen in 2002. It is a large molecule, with a molecular weight of 150 kDa., that binds to TNFα and decreases its role in disorders involving excess inflammation in humans and other animals, including autoimmune diseases such as ankylosing spondylitis, juvenile rheumatoid arthritis, psoriasis, psoriatic arthritis, rheumatoid arthritis, and, potentially, in a variety of other disorders mediated by excess TNFα. In North America, etanercept is co-marketed by Amgen and Pfizer under the trade name Enbrel in two separate formulations, one in powder form, the other as a pre-mixed liquid. Wyeth is the sole marketer of Enbrel outside North America excluding Japan whereTakeda Pharmaceuticals markets the drug. Etanercept is an example of a protein-based drug created using the tools of biotechnologyand conceived through an understanding afforded by modern cell biology. |
Promising Antiviral Compounds Discovered
Scientists sifted through thousands of potentially efficacy compounds and managed to identify two promising candidates for the development of drugs against human adenovirus, a cause of ailments ranging from colds to gastrointestinal disorders to pink eye
Scientists at the U.S. Department of Energy’s Brookhaven National Laboratory have identified two promising candidates for the development of drugs against human adenovirus, a cause of ailments ranging from colds to gastrointestinal disorders to pink eye. A paper published in FEBS Letters, a journal of the Federation of European Biochemical Societies, describes how the researchers sifted through thousands of compounds to determine which might block the effects of a key viral enzyme they had previously studied in atomic-level detail.
Quad Pill for HIV Appears Safe in Renal Disease
Published: Jul 7, 2013
KUALA LUMPUR — HIV patients with mild to moderate renal impairment appear to tolerate treatment with a combination tablet that contains drugs known to impact kidney function, a phase III, open-label, two-cohort study found.
The treatment group receiving the four-drug combination of elvitegravir, cobicistat, tenofovir DF, and emtricitabine, branded as Stribild
GSK tests ofatumumab in rare skin disorder
GlaxoSmithKline is to start a new Phase III study of ofatumumab as a treatment for pemphigus vulgaris, a rare autoimmune disorder of the skin, according to partner Genmab. The Danish biotech and the drug major are long-term partners on ofatumumab which is already marketed, as Arzerra, for chronic lymphocytic leukaemia.
http://www.pharmatimes.com/Article/13-07-04/GSK_tests_ofatumumab_in_rare_skin_disorder.aspx
Ofatumumab(trade name Arzerra, also known as HuMax-CD20) is a human monoclonal antibody (for the CD20 protein) which appears to inhibit early-stage B lymphocyte activation. It is FDA approved for treating chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab (Campath) and has also shown potential in treating Follicular non-Hodgkin’s lymphoma, Diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Ofatumumab has also received conditional approval in Europe for the treatment of refractory chronic lymphocytic leukemia. This makes ofatumumab the first marketing application for an antibody produced by Genmab, as well as the first human monoclonal antibody which targets the CD20 molecule that will be available for patients with refractory CLL.
Orexo gets FDA OK for opioid dependence drug
Regulators in the USA have given the green light to Orexo of Sweden’s Zubsolv as a treatment for opioid addiction.
The US Food and Drug Administration has approved Zubsolv, a once-daily sublingual formulation of Reckitt Benckiser’s Suboxone (buprenorphine/naloxone) which currently dominates the market. It is indicated for use as maintenance treatment for people suffering from opioid dependence and should be used as part of a complete treatment plan to include counselling and psychosocial support
read all at
http://www.pharmatimes.com/Article/13-07-05/Orexo_gets_FDA_OK_for_opioid_dependence_drug.aspx
Lycopene: reducing the risk of cancer and cardiovascular disease, effect on the eye and bone health or hepatoprotective properties
Lycopene is a natural carotenoid occurring in tomatoes and many other non-animal sources including fruits, vegetables and microorganisms. Lycopene has been shown to provide many health benefits such as reducing the risk of cancer and cardiovascular disease, effect on the eye and bone health or hepatoprotective properties. These health benefits together with its red color make it an attractive ingredient for functional foods.
In foods, lycopene can be successfully delivered in the form of oil-in-water emulsions, but in order to preserve its unique antioxidant properties, it has to be protected from premature oxidation.
read at
http://www.chemistryviews.org/details/news/1070983/Lycopene_Preventing_Degradation.html
- Effect of different antioxidants on lycopene degradation in oil-in-water emulsions,
Ricard Bou, Caitlin Boon, Asiamah Kweku, Diana Hidalgo, Eric A. Decker,
Eur. J. Lipid Sci. Technol. 2011, 113.
DOI: 10.1002/ejlt.201000524
Stem Cell Research – encouraging results – caustiously optimistic
Two HIV-positive patients in the United States who underwent bone marrow transplants for cancer have stopped anti-retroviral therapy and still show no detectable sign of the HIV virus, researchers said Wednesday.
The first person reported to be cured of HIV, American Timothy Ray Brown, underwent a stem cell transplant in 2007 to treat his leukemia. He was reported by his German doctors to have been cured of HIV two years later.
The researchers, Timothy Henrich and Daniel Kuritzkes of the Harvard-affiliated Brigham and Women’s Hospital in Boston, announced last year that blood samples taken from the men — who both had blood cancers — showed no traces of the HIV virus eight months after they received bone marrow transplants to replace cancerous blood cells with healthy donor cells.
“These findings clearly provide important new information that might well alter the current thinking about HIV and gene therapy,” Kevin
View original post 57 more words
Novartis’ eye drug Lucentis gains fourth indication approval in Europe
July 5 2013 | By Márcio Barra
In a press release launched today, Novartis announced that the EU has approved Lucentis (Ranibizumab) as the first effective treatment of sight problems caused by choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV).
View original post 333 more words
FDA approves Orexo’s Zubsolv for people suffering from opioid dependence
U.S. Food and Drug Administration (FDA) has approved Zubsolv™ (buprenorphine/naloxone) sublingual tablet CIII. Zubsolv is indicated for use as maintenance treatment for people suffering from opioid dependence and should be used as part of a complete treatment plan to include counselling and psychosocial support. Zubsolv is a once-daily, sublingual tablet with an advanced formulation of buprenorphine and naloxone that fully dissolves within minutes. Compared with other buprenorphine/naloxone treatments, Zubsolv has higher bioavailability, faster dissolve time, and smaller tablet size with a new menthol taste. Zubsolv will be launched in September by our subsidiary in the United States, Orexo US, Inc and our partner Publicis Touchpoint Solutions…
FDA approves Orexo’s Zubsolv for people suffering from opioid dependence.
New Drug Approvals 