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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Study links vitamin D deficiency to accelerated bone aging
Robert Ritchie (left) and Hrishikesh Bale used a combination of FTIR spectroscopy and X-ray CT at the Advanced Light Source to find that vitamin D deficiency speeds the aging process of bone and reduces its quality. Photo by Roy Kaltschmidt
A team of scientists led by researchers at Lawrence Berkeley National Laboratory and the Univ. of California, Berkeley, have recently used a combination of Fourier transform infrared spectroscopy and X-ray computed tomography at the Advanced Light Source to find that vitamin D deficiency speeds the aging process of bone and reduces its quality.FULL STORY
Novartis teams with India’s Biological E for typhoid vaccine development
Novartis teams with India’s Biological E for typhoid vaccine…
| Novartis and Indian biopharma Biological E have entered into a development and licensing agreement to deliver accessible and affordable typhoid and paratyphoid A vaccines to the developing world. Yearly, over 21 million cases and 5 million cases of typhoid and paratyphoid A… read more › |
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H7N9 vaccines in development–where are we?
Since early 2013, the newly emergent H7N9 avian influenza virus has been infecting humans in China, leading to the temporary closure of numerous poultry markets in a bid to control the outbreak. In recent weeks, the rate at which new cases are reported has been declining – but some experts are asking whether this is just the calm before the storm. The development of a vaccine against the virus is therefore still of great interest – but where are we with vaccine development?
Inovio Pharmaceuticals announced on July 8th that in a preclinical study of its influenza DNA vaccine, 100% of the vaccinated animals were protected against sickness and death when challenged with a lethal dose of A/Anhui/1/13 strain of H7N9 virus. On the same day, Novavax made an announcement that enrolment had begun for a Phase I clinical trial of its monovalent virus-like particle (VLP) vaccine candidate – again based on the A/Anhui/1/13 strain
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Omthera files heart drug anti-triglyceride, Epanova with FDA
july, 10, 2013
Omthera Pharmaceuticals, which is in the process of being acquired by AstraZeneca, has filed its anti-triglyceride drug Epanova with regulators in the USA.The Princeton, New Jersey-based company is seeking approval from the US Food and Drug Administration to sell Epanova, a coated soft gelatin capsule containing a mixture of polyunsaturated free fatty acids derived from fish oils, for the treatment of patients with severe hypertriglyceridemia. The submission is based on two Phase III trials (EVOLVE and ESPRIT) examining the effectiveness of Epanova in lowering very high triglycerides, and in reducing non-HDL cholesterol in combination with a statin. Both trials were conducted under a special protocol assessment with the FDA.
The filing will please AstraZeneca which announced at the end of May that it will buy Omthera for $12.70 per share, or around $323 million. In addition to the cash payment, each Omthera shareholder will receive contingent value rights of up to $4.70 per share – or around $120 million in total – if specified milestones related to Epanova are achieved.
When the deal was announced, Omthera chief executive Gerald Wisler said he expects AstraZeneca to “maximise the value of Epanova not only as a monotherapy treatment for dyslipidemia but also as a treatment for cardiovascular disease in combination with Crestor (atorvastatin)”, the firm’s cholesterol blockbuster.
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.
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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.
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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.
New Drug Approvals 