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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Flamel Technologies Announces FDA Approval of Bloxiverz
LYON, FRANCE — (Marketwire) — 06/03/2013 — Flamel Technologies today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for Bloxiverz (neostigmine methylsulfate), a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Flamel expects to launch Bloxiverz in July 2013 in 0.5 and 1.0 mg/mL strengths
read all at
.http://www.drugs.com/newdrugs/flamel-technologies-announces-fda-approval-bloxiverz-3802.html
GSK Duchenne drug gets ‘breakthrough’ status
The US Food and Drug Administration has granted breakthrough therapy designation to GlaxoSmithKline’s drisapersen for the potential treatment of patients with Duchenne muscular dystrophy. read all at
http://www.pharmatimes.com/Article/13-06-28/GSK_Duchenne_drug_gets_breakthrough_status.aspx
Drisapersen (also known as PRO051 and GSK2402968 ) is an experimental drug under development by Prosensa for the treatment of Duchenne muscular dystrophy.
The compound is in a Phase III trial which is anticipated to complete by the end of 2013.
- ^ “PRO051/GSK2402968”. Prosensa. Retrieved 29 October 2012
- ^ “A Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy (DMD114044)”. ClinicalTrials.gov. Retrieved 29 October 2012.
Lyxumia approved in Japan for the treatment of type 2 diabetes
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FDA Approves Rixubis – First Recombinant Coagulation Factor IX For Use in Preventing Bleeding Episodes
Rixubis [Coagulation Factor IX (Recombinant)]
June 27, 2013 — The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes, perioperative (period extending from the time of hospitalization for surgery to the time of discharge) management, and routine use to prevent or reduce the frequency of bleeding episodes (prophylaxis).
read all at
Date rape drug sensor
The first fluorescent sensor for known date rape drug gamma-butyrolactone (GBL) has been developed in Singapore. It emits orange fluorescence in alcoholic drinks containing GBL when irradiated with a green laser.
Gamma-butyrolactone (GBL) is a readily available industrial solvent that is often used as a date rape drug. There are several detection kits that can show if a drink has been spiked with drugs like gamma-hydroxybutyric acid (GHB) and ketamine but there are no commercially available sensors to detect GBL.
http://www.rsc.org/chemistryworld/2013/06/date-rape-drug-sensor-gamma-butyrolactone
read also
Fernando Patolsky and Michael Ioffe of Tel Aviv University developed a sensor that, when dipped into a drink, will instantly detect the presence of a drug such as GHB, ketamine, or Rohypnol.
more info on other drug
Predatory drugs or date rape drugs are responsible for the creation of the most dangerous and pathologic environment that exists around drug use and drug abuse. Predatory drugs are a general class of drug that are primarily used to “render the victim incapable of resisting sexual advances”. (U.S. DEA)
This statement does not imply that the drug makes a person desire sexual activity, but quite the opposite. Predatory drugs leave the victim helpless, possibly unconscious, but certainly without any memory of a crime being committed against him/her. It can not be emphasized enough that giving someone a predatory drug is not only morally reprehensible it is also a serious criminal act. Illicit use of date rape drugs involve some of the most pathologic criminals who are involved with our justice system.
Misspellings: Ketamene, Ketimane, Rohipnol, Rophinol
What is Date Rape Drug Addiction?
So called date rape drugs are also found at rave parties, clubs, college parties, and even in high school social environments. They are potent drugs that can cause serious health problems, developmental problems, overdose and death. To further complicate the effects of these drugs, many are produced in illegal labs. Illicit production of drugs means there is no quality control standards. The lack of quality control standards can greatly diminish the purity of the drugs and leaves the user vulnerable to harsh chemicals and possibly overdose. Most of the chemicals found in date rape drugs are not intended for human consumption.
The number of drugs that are considered predatory drugs is increasing. To date, the most commonly used are:
- GHB – GBH’s chemical name is gama hydroxybutyrate and is currently a
DEA
schedule 1 drug that has central nervous system depressant effects.
- GBL/1 – GBL is a pro-drug of GHB and produces the same effects.
- 4-BD – The chemical name of 4-BD is 1,4-Butanediol and is used industrially as a solvent. When taken recreationally, it produces the same effects as GHB.
- Ketamine – Ketamine, or special K, as it is known on the streets, is a type of anesthetic known as a dissociative anesthetic and is approved for human and veterinarian use. When taken recreationally, it produces euphoria and hallucinations.
- Rohypnol – The generic name of Rohypnol is flunitrazepam and it is marketed as a potent hypnotic, sedative, and it produces amnesia. It is in the class of drugs known as benzodiazepines.
Some of these drugs are made from industrial strength floor cleansers, lye, and Dranno and can cause brain damage.
Signs and Symptoms Date Rape Drugs Addiction
The regular use of drugs such as GHB/GBL used to lower inhibitions can create significant side effects. The most common side effects produced by the recreational use of date rape drugs are:
- Psychosis and severe agitation requiring self-protection procedures and sedation
- Mild tachycardia (increased heart rate) and hypertension
- Neurologic effects, including prolonged delirium
- Hallucinations
- Diaphoresis (profuse sweating), nausea, and vomiting
- Overdose, coma, and death
Because of the memory loss associated with these drugs, the user can be prone to use again and again without memory of severe side effects. Once used regularly, date rate drugs could also lead to serious withdrawal symptoms. These withdrawal symptoms will require medical attention and medication.
Beyond the physical dependence an emotional dependence can quickly develop. Once regular use begins an addict can experience personality changes which may result in aggressive behavior, a disregard for authority, a disregard for personal safety, risky sexual behavior, a loss of boundaries, financial difficulties, problems at school or work, a change in friends, and the loss of interest in normal activities.
No one plans on becoming an addict but the power of drugs on the brain’s functioning, accompanied by the alterations in the neuroreceptors, drives the addiction process. It is not about choice or desire once the body’s systems have been affected. Date rape drugs or predatory drugs are extraordinarily powerful both in their addictive qualities and the serious, negative, health consequences that accompany regular use.
TOSEDOSTAT CLINICAL TRIALS
Tosedostat
Benzeneacetic acid, α-[[(2R)-2-[(1S)-1-hydroxy-2-(hydroxyamino)-2-oxoethyl]-4-methyl-1-oxopentyl]amino]-, cyclopentyl ester, (αS)-
Cyclopentyl (2S)-({(2R)-2-[(1S)-1-hydroxy-2-(hydroxyamino)-2-oxoethyl]-4-methylpentanoyl}amino)(phenyl)acetate
[238750-77-1]
Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today issued the following statement regarding the notification of the U.S. Food and Drug Administration (the “FDA”) partial clinical hold on tosedostat (IND 075503), the Company’s aminopeptidase inhibitor under development for the treatment of blood-related cancers, that is being studied in an investigator-sponsored trial and not by CTI. CTI’s primary development programs are the ongoing Phase 3 trial of pacritinib, the Company’s JAK2/FLT3 inhibitor being evaluated for patients with myelofibrosis, and the post-approval commitment study of PIXUVRI®(pixantrone).
http://www.heraldonline.com/2013/06/25/4972677/cti-issues-statement-regarding.html
EU OKs Nuedexta for PBA
Avanir Pharmaceuticals, Inc. today announced that the European Commission has approved NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) in the European Union for the treatment of pseudobulbar affect (PBA), irrespective of underlying neurologic disease or injury.
http://www.pharmalive.com/avanir-pharmaceuticals-announces-european-approval-of-nuedexta
NUEDEXTA is an oral formulation of dextromethorphan hydrobromide USP and quinidine sulfate USP in a fixed dose combination.
Dextromethorphan hydrobromide is the pharmacologically active ingredient of NUEDEXTA that acts on the central nervous system (CNS). The chemical name is dextromethorphan hydrobromide: morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α)- hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C18H25NO•HBr•H2O with a molecular weight of 370.33. The structural formula is:
Quinidine sulfate is a specific inhibitor of CYP2D6-dependent oxidative metabolism used in NUEDEXTA to increase the systemic bioavailability of dextromethorphan. The chemical name is quinidine sulfate: cinchonan-9-ol, 6’-methoxy- (9S) sulfate (2:1), (salt), dihydrate. Quinidine sulfate dihydrate has the empirical formula of (C20H24N2O2)2•H2SO4•2H2O with a molecular weight of 782.96. The structural formula is:
The combination product, NUEDEXTA, is a white to off-white powder. NUEDEXTA is available for oral use as NUEDEXTA which contains 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate. The active ingredients are dextromethorphan hydrobromide monohydrate USP and quinidine sulfate dihydrate USP.Inactive ingredients in the capsule are croscarmellose sodium NF, microcrystalline cellulose NF, colloidal silicon dioxide NF, lactose monohydrate NF, and magnesium stearate NF.
Sanofi’s new insulin U300 superior to Lantus: study
Sanofi’s investigational diabetes drug U300, cas no 160337-95-1, insuline glargine, new formulation is better at controlling dangerous low blood sugar events at night than its blockbuster Lantus, according to data from a phase III clinical programme.
insulin glargine
Lantus, developed in the 1990s, is currently Sanofi’s top-selling product, generating $6.6bn last year. But the drug is expected to lose its patent in 2015.
http://www.medscape.com/viewarticle/805067 says no cancer risk
http://clinicaltrials.gov/ct2/show/NCT01689142 reports clinical trials
To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in patients with type 2 diabetes mellitus.
Secondary Objectives:
- To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose, pre-injection plasma glucose, 8-point self-measured plasma glucose profile.
- To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia
Insulin glargine is produced by recombinant DNA technology using a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. It is an analogue of human insulin made by replacing the asparagine residue at position A21 of the A-chain with glycine and adding two arginines to the C-terminus (positions B31 and 32) of the B-chain. The resulting protein is soluble at pH 4 and forms microprecipitates at physiological pH 7.4. Small amounts of insulin glargine are slowly released from microprecipitates giving the drug a long duration of action (up to 24 hours) and no pronounced peak concentration.
GRAVIOLA TREE “10000 TIMES STRONGER KILLER OF CANCER THAN CHEMO” – FACTS ANALYSIS
“10000 times stronger killer of Cancer than Chemo”.. do share it.. can save many lives, fill up hopes and build confidence in the patients…
The Sour Sop or the fruit from the graviola tree is a miraculous natural cancer cell killer 10,000 times stronger than Chemo. Why are we not aware of this?
read all at
http://www.hoaxorfact.com/Health/graviola-tree-10000-times-stronger-killer-of-cancer-than-chemo.html
Dulaglutide Shows Superiority in Phase 3 Trials
DULAGLUTIDE
STRUCTURAL FORMULA
Monomer
HGEGTFTSDV SSYLEEQAAK EFIAWLVKGG GGGGGSGGGG SGGGGSAESK 50
YGPPCPPCPA PEAAGGPSVF LFPPKPKDTL MISRTPEVTC VVVDVSQEDP 100
EVQFNWYVDG VEVHNAKTKP REEQFNSTYR VVSVLTVLHQ DWLNGKEYKC 150
KVSNKGLPSS IEKTISKAKG QPREPQVYTL PPSQEEMTKN QVSLTCLVKG 200
FYPSDIAVEW ESNGQPENNY KTTPPVLDSD GSFFLYSRLT VDKSRWQEGN 250
VFSCSVMHEA LHNHYTQKSL SLSLG 275
Disulfide bridges location
55-55′ 58-58′ 90-150 90′-150′ 196-254 196′-254′
http://www.ama-assn.org/resources/doc/usan/dulaglutide.pdf
7-37-Glucagon-like peptide I [8-glycine,22-glutamic acid,36-glycine] (synthetic
human) fusion protein with peptide (synthetic 16-amino acid linker) fusion protein with
immunoglobulin G4 (synthetic human Fc fragment), dimer
Eli Lilly and Co. announced detailed safety and efficacy results from three Phase 3 AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being studied as a once-weekly treatment for type 2 diabetes
New Drug Approvals 