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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Sanofi Updates Lantus Label in EU, ORIGIN Results on Lantus® Cardiovascular Safety Integrated Into European Union Product Label
Lantus® (insulin glargine)
June 5, 2013 –
Sanofi announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for inclusion in the Lantus® (insulin glargine) product label of safety and efficacy data from the insulin glargine cardiovascular (CV) outcomes trial ORIGIN (Outcome Reduction with Initial Glargine INtervention). The revised label is evidence of Sanofi’s ongoing commitment to further assert the well-known safety and efficacy profile of insulin glargine, the most-studied basal insulin. The indication for the use of Lantus® remains unchanged.
| Mechanism of Action |
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| Insulin glargine (lantus) mechanism of action. |
LANTUS (insulin glargine rdna origin injection) consists of insulin glargine dissolved in a clear aqueous fluid. Each milliliter of LANTUS (insulin glargine rdna origin injection) contains 100 IU (3.6378 mg) insulin glargine.
LANTUS® is a sterile solution of insulin glargine for use as an injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up to 24-hour duration of action), parenteral blood-glucose-lowering agent., LANTUS (insulin glargine rdna origin injection) is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acidasparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Chemically, it is 21A– Gly-30Ba-L-Arg-30Bb-L-Arg-human insulin and has the empirical formula C267H404N72O78S6 and a molecular weight of 6063.
FDA Approves Revlimid (lenalidomide) for the Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma
Lenalidomide (Revlimid)
EP 0925294; US 5635517; WO 9803502,Drugs Fut 2003, 28, 5, 425.Bioorg Med Chem Lett 1999, 9, 11, 1625
RS)-3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol- 2-yl)piperidine-2,6-dione
Jun. 5, 2013– Celgene Corporation today announced the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental new drug application (sNDA) for Revlimid (lenalidomide) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
Revlimid is used to treat a certain type of myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells) caused by an abnormal chromosome. Revlimid is also used to treat anemia (a lack of red blood cells in the body) and along with dexamethasone for the treatment of multiple myeloma (a type of cancer of the bone marrow) who have received at least one prior therapy.
Lenalidomide (Revlimid) is a derivative of thalidomide introduced in 2004.
It was initially intended as a treatment for multiple myeloma, for which thalidomide is an accepted therapeutic treatment. Lenalidomide has also shown efficacy in the class of hematological disorders known as myelodysplastic syndromes (MDS). Lenalidomide has significantly improved overall survival in myeloma (which generally carries a poor prognosis), although toxicity remains an issue for users. It costs $163,381 per year for the average patient.
Use in USA
On June 29, 2006, lenalidomide received U.S. Food and Drug Administration (FDA) clearance for use in combination with dexamethasone in patients with multiple myeloma who have received at least one prior therapy.
As of 2011, the FDA has initiated an ongoing review of Revlimid. The review focuses on clinical trials which found that Revlimid caused an increased risk of developing new malignancies such as acute myelogenous leukemia (AML) and B-cell lymphoma.The FDA is currently advising all patients on Revlimid to continue their treatment
Use in the UK
On 23 April 2009, The National Institute for Health and Clinical Excellence (NICE) issued a Final Appraisal Determination (FAD) approving lenalidomide, in combination with dexamethasone, as an option to treat patients who suffer from multiple myeloma who have received two or more prior therapies in England and Wales.
Use in Australia -While lenalidomide is not approved for first-line treatment of multiple myeloma in Australia, in clinical trials of newly diagnosed multiple myeloma, a four-fold increase in the incidence of second primary malignancies has been observed in patients receiving lenalidomide (7.0%) compared to controls (1.8%). These included cases of acute myeloid leukaemia, myelodysplastic syndrome and solid tumours in patients receiving lenalidomide.
DENGUE FEVER by Prof. D. S. Akram, Dr. Saba Ahmed
Dengue fever (DF) and Dengue hemorrhagic fever (DHF) rank high among infectious diseases and are considered to be most important of arthropod born viral diseases
MOSQUITO VECTOR DF is caused by mosquito of genus Aedes ,most important is A.aegypti which is a day biting mosquito, rests indoors and can breed in small collection of water. Rainy season increase risk of DF as it increases larval population ,also ambient temperature and humidity favor viral propagation
Chikungunya an update by Dr.T.V.Rao MD
The Aedes aegypti mosquito biting a person.
WHAT IS CHIKUNGUNYA• Manifest with Crippling Arthritic disease of sudden onset.• Name is derived from Swahili – Chikungunya meaning that which bends up• Virus isolated in 1953 from serum and Aedes mosquitoes and Culex spp
Chikungunya is a virus that is transmitted from human to human mainly by infected Aedes albopictus and Aedes aegypti mosquitoes (later referred to as Aedes mosquitoes) acting as the disease-carrying vector• Chikungunya causes sudden onset of high fever, severe joint pain, muscle pain and headache• As no vaccine or medication is currently available to prevent or cure the infection, control of Chikungunya involves vector control measures and encouraging people to avoid mosquito bites
http://www.slideshare.net/doctorrao/chikungunya-an-update
Ayurveda Cure of Malaria
Malaria is a worldwide problem. Ayurveda, the Indian system of medicine have answer to cure the Malaria and its complications.
http://www.slideshare.net/drdbbajpai/ayurveda-cure-of-malaria
Ayurveda Herbs : Medicinal uses of Turmeric
http://www.slideshare.net/drdbbajpai/ayurveda-herbs-medicinal-uses-of-turmeric?from_search=2
………………
Composition
Turmeric contains up to 5% essential oils and curcumin of about three percent by weight, a polyphenol. Curcumin is the active substance of turmeric and curcumin is known as C.I. 75300, or Natural Yellow 3. The systematic chemical name is (1E,6E)-1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione.
It can exist at least in two tautomeric forms, keto and enol. Curcumin is a pH indicator. In acidic solutions (pH <7.4) it turns yellow, whereas in basic (pH > 8.6) solutions it turns bright red.
New late-stage data on Boehringer Ingelheim’s lung cancer drug nintedanib and its benefit to overall survival in some patients has caused a stir at the American Society of Clinical Oncology meeting in Chicago.
nintedanib
The German drugmaker presented results from the LUME-Lung 1 Phase III trial looking at the addition of nintedanib, to docetaxel as a second-line treatment in patients with advanced non-small cell lung cancer (NSCLC) compared to chemotherapy alone.
New late-stage data on Boehringer Ingelheim’s lung cancer drug nintedanib and its benefit to overall survival in some patients has caused a stir at the American Society of Clinical Oncology meeting inChicago.
read all at
http://www.pharmatimes.com/Article/13-06-04/Boehringer_NSCLC_drug_impresses_at_ASCO.aspx
Nintedanib (also known as BIBF 1120 and Vargatef) is a small molecule inhibitor of vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet derived growth factor receptor (PDGFR) being developed by Boehringer Ingelheim for use as an anti-vascular anti-cancer agent.
Tesaro and the European Network of Gynecological Oncological Trial Groups Forge Partnership to Develop Niraparib for Ovarian Cancer
Niraparib; MK 4827
MOLECULAR FORMULA C19H20N4O
MOLECULAR WEIGHT 320.4
SPONSOR Merck Sharp & Dohme Corp.
CAS REGISTRY NUMBER 1038915-60-4
THERAPEUTIC CLAIM Antineoplastic
CHEMICAL NAMES
1. 2H-Indazole-7-carboxamide, 2-[4-(3S)-3-piperidinylphenyl]-
2. 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide
TESARO and the European Network of Gynecological Oncological Trial Groups (ENGOT) Forge Partnership to Develop Niraparib for Ovarian Cancer
June 3, 2013 — TESARO, Inc. an oncology-focused biopharmaceutical company, and the European Network of Gynecological Oncological Trial Groups (ENGOT), a network of national and regional clinical trial organizations, today announced a partnership for the Phase 3 clinical development of niraparib, an orally active, potent poly (ADP-ribose) polymerase (PARP) inhibitor. READ ALL AT http://www.pharmalive.com/tesaro-and-the-european-network-of-gynecological-oncological-trial-groups-forge-partnership-to
http://www.ama-assn.org/resources/doc/usan/niraparib.pdf
http://clinicaltrials.gov/show/NCT01847274
MK-4827:
MK-4827 is a potent, Selective, PARP 1/2 inhibitor with IC50 of 3.8 and 2.1 nM for PARP1 and 2, respectively. MK-4827 possesses potential Antineoplastic Activity. In a Whole Cell assay, MK -4827 prevented PARP activity with an EC50 of 4 nM, enhancing the accumulation of DNA strand breaks and promoting genomic instability and apoptosis. MK-4827 induces selective synthetic lethality in homologous recombination (HR) repair deficient tumors with BRCA1 / 2 loss and tumor cell lines with non-BRCA-related HR defects, supporting clinical utility in sporadic tumors. MK-4827 reveals good pharmacokinetic properties and is currently in phase I clin. trials. The phase I clinical trials for MK-4827 is ongoing in the treatment of solid tumors.
BY WORLD DRUG TRACKER
Drug to ‘cure’ cravings-compound found in the bark of an African bush may hold clues to the development of drugs for reversing a host of addictive behaviours from drug
(–)-18-Methoxycoronaridine (18-MC)
A compound found in the bark of an African bush may hold clues to the development of drugs for reversing a host of addictive behaviours from drug and alcohol abuse and even smoking and compulsive over-eating, scientists reported at the BIO convention in Chicago, US, in April 2013.
read all at
http://www.soci.org/Chemistry-and-Industry/CnI-Data/2013/5/Drug-to-cure-cravings
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(–)-18-Methoxycoronaridine (18-MC) is a derivative of ibogaine invented in 1996 by the research team around the pharmacologist Stanley D. Glick from the Albany Medical College and the chemist Martin E. Kuehne from the University of Vermont. In animal studies it has proved to be effective at reducing self-administration of morphine, cocaine, methamphetamine, nicotine and sucrose. 18-MC is a selective α3β4 nicotinic antagonist and, in contrast to ibogaine, has no affinity at the α4β2 subtype nor at NMDA-channels nor at the serotonin transporter, and has significantly reduced affinity for sodium channels and for the σ receptor, but retains modest affinity for the μ and κ opioid receptors. The sites of action in the brain include the medial habenula, interpeduncular nucleus, dorsolateral tegmentum and basolateral amygdala. It has also been shown to produce anorectic effects in obese rats, most likely due to the same actions on the reward system which underlie its anti-addictive effects against drug addiction.
18-MC has not yet been tested in humans. In 2002 the research team started trying to raise funds for human trials, but were unable to secure the estimated $5 million needed. Efforts to raise funds for future trials are still ongoing. In January 2010, Obiter Research, a chemical manufacturer in Champaign, Illinois, signed a patent license with Albany Medical College and the University of Vermont allowing them the right to synthesize and market 18-MC and other congeners.
A number of derivatives of 18-MC have also been developed, with several of them being superior to 18-MC itself, the methoxyethyl congener ME-18-MC being more potent than 18-MC but with similar efficacy, and the methylamino analogue 18-MAC being more effective than 18-MC but with around the same potency. These compounds were also found to act as selective α3β4 nicotinic acetylcholine antagonists, with little or no effect on NMDA receptors.
BY WORLD DRUG TRACKER
Impotence: When You Can’t Get It Up is Getting You Down
Probably nothing devastates a man more than having a failure in the bedroom. Impotence or erectile dysfunction affects nearly 33 million men in the United States. You are not alone. Help is available for nearly every man who has erectile dysfunction.
Diet
According to the Urology Channel’s “Erectile Dysfunction: Natural/Alternative Treatments,” erectile dysfunction can be treated by eating right, drinking plenty of water and avoiding sugar, dairy and caffeine. They recommend to eat whole, fresh, unrefined and unprocessed foods, including vegetables, whole grains, soy, beans, seeds, nuts, olive oil and cold-water fish such as salmon and tuna.
Taking your vitamins can also help; the Urology Channel suggests supplements such as flaxseed, and in particular vitamins C, E and the mineral zinc. These vitamins and supplements help bolster the vascular system, which is an important part of good sexual health.
Exercise
Since sexual health relies on the vascular system, a strong heart…
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New Drug Approvals 