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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Pfizer’s Vacine Prevenar 13 receives approval from the European Comission for wider use
July 10 2013 | By Márcio Barra
Pfizer’s Prevenar 13, a pneumococcal conjugate vaccine already in use in infants, young children and adolescents between ages of 6 weeks and 17 years and adults of 50 years and over, received approval today by European Comission to be used in a wider age group – adults aged 18 to 49 years for active immunization for the prevention of invasive disease caused by vaccine-type Streptococcus pneumoniae.
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GSK files Supplemental New Drug Applications for melanoma combo, signs Immunocore pact
July 09, 2013
GlaxoSmithKline has filed its two newly-approved drugs Tafinlar and Mekinist to be used in combination for melanoma with regulators in the USA.
Supplemental New Drug Applications have been made to the US Food and Drug Administration for use of Tafinlar (dabrafenib), a BRAF inhibitor, in combination with Mekinist (trametinib), a MEK inhibitor for the treatment of adults with unresectable or metastatic melanoma with a BRAF V600 E or K mutation. The files are based on data from a Phase I/II study comparing dabrafenib monotherapy to the combo.
read all at
http://www.pharmatimes.com/Article/13-07-09/GSK_files_melanoma_combo_signs_Immunocore_pact.aspx
Tafinlar (dabrafenib)
Mekinist (trametinib)
Novartis psoriasis drug demonstrated superiority to Enbrel in Phase III trial
July 8 2013 | By Márcio Barra
Novartis announced today that their experimental psoriasis drug secukinumab was more effective in a Phase III trial than Pfizer’s and Amgen’s Enbrel (Etarnacept) in clearing the skin of patients with moderate to severe plaque-type psoriasis.
The trial, called FIXTURE, is a pivotal trial intended for registration, where secukinumab was compared to both placebo and Enbrel. While final results will only be released later this year, secukinumab met all primary and secondary endpoints on the drug’s safety, tolerability and short term and long term efficacy parameters. Whether the findings will give secukinumab sufficient differentiation over the anti-TNF drugs – its ability to reduce the risk of severe infections compared with the anti-TNFs will be crucial – will become clearer when the data is released, possibly at the American College of Rheumatology in October
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Oramed Enrolls First Patient in its Phase 2a U.S. Oral Insulin Clinical Trial
Nadav Kidron
Marks initiation of Oramed’s first FDA trial for its flagship ORMD-0801 oral insulin product
JERUSALEM, July 8, 2013
Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the first patient has been enrolled in a Phase 2a trial of ORMD-0801, an orally ingestible insulin capsule, on patients with type 2 diabetes. The current trial is to be a randomized, double-blind study designed to assess the safety of ORMD-0801.
Read more at
In addition to ORMD-0801, Oramed is also developing an oral GLP-1 analog, known as exenatide, and a combination therapy of ORMD-0801 and exenatide.
GLP-1, or glucagon-like peptide-1, possesses a number of physiological properties that make it and its analogs the subject of intensive investigation as a potential treatment for diabetes. Among other things, it aids in the balance of blood sugar levels by decreasing glucose levels, especially after a meal; promotes weight loss; and does not cause hypoglycemia.
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
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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).
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New Drug Approvals 