Maestro rechargeable system for obese adults

US FDA approved maestro rechargeable system for obese adults , first weight loss treatment device that targets the nerve pathway between brain and stomach that controls feelings of hunger and fullness . This device is approved to treat patients aged 18 and older who have not been able to loose weight with loss program and with Body Mass Index (BMI) 35 to 45.
     Maestro rechargeable system consists of a rechargeable electrical  pulse generator , wire leads and electrodes surgically implanted in to body abdomen . It works by sending intermittent electrical pulses to the trunks in the abdominal vague nerve , which plays role in sending to the brain that stomach feels empty .
           External controllers allow the patient to charge device and allow health care professionals to adjust the devices settings  in order to provide optional therapy with minimal side effects.
maestro rechargeable system in manufactured by Entero medics of st. paul, Minnesota.

simillarity factor in UV spectrophotometer caliculation

Simillarity factor in assay by UV  is caliculatedy by using the formula standard weight 1/standard weight 2*standard absorbancw 2/standard absorbance 1

Acceptance criteria for simillarity factor is 9.8 to 1.2

Xultophy(IDegLira) ,a combination of insulin degludec(Tresibar) and liraglutide(Victoza) is approved by European Commission for marketing in EU

Xultophy(IDegLira) ,a combination of insulin degludec(Tresibar) and liraglutide(Victoza) is approved by European Commission for marketing in EU states .Xultophy  once daily injection is indicated for treatment of adults with type 2 dieabetes mellitus  . This drug improves glycaemic control in combination with  oral glucose -lowering  products.
when compared with insulin degludec ,Xultophy showed reduction in HbA1C of 1.9% with mean weight loss of 2.7 kg  and also a low rate of hypoglycaemia.
Novo Nordisk, the developer of Xultophy(IDegLira) has submitted marketing authorisation with EU on may 31st of '13 and got approval in Switzerland on 12 september  '14
Chemistry:
Insulin degludec:
Structure:Modified insulin with 1 single amino acid delted in comparison to human insulin and  cojugated to hexadecanedioic acid via gamma-L-glutamyl spacer at amino acid Lysine at B29 position.
IUPAC name:B29N(epsilon)-omega-carboxypentadecanoyl-gamma-L-glutamyl desB30 human insulin
Mechanisam of Action(MOA): It forms multi hexamers in subcutaneous tissues by addition of hexadecanedioic acid to lysine at the B29 position .This results in in formation of a subcutaneous depot that results in slow insulin release in to systemic circulation.
Duration of action: It is  ultra-long acting with duration which lasts up to 40 hours .
Liraglutide:
Molecular Formula:C17H265N43051
Molecular Weight:3751.202
MOA of Liraglutide:
1-Liraglutide increases intracellular cyclic AMP[cAMP]  which leads to insulin release in presence of elevated glucose concentrations.This secretion subsides a s glucose concentrations decrease and approach euglycemia.
2-decreasing glucagon secretion in glucose dependent manner
3-delaying gastric emptying.

Saxenda (Liraglutide) of Novo Nordisk received 14-1 positive vote for approval from EMDAC of US FDA.

Saxenda (Liraglutide) of Novo Nordisk received 14-1 positive vote for approval from EMDAC ( Endocrinologic an Metabolic Drugs Advisory  Committee) of US FDA.
The panel members were asked to discuss whether Novo Nordisk has provided enough data to establish the safety and efficacy profile of Saxenda(Liraglutide)  for chronic weight management based on the NDA data submitted.
Overall benefit-risk assessment of Saxenda(Liraglutide) got 14-1 votes from the panel members for weight management in patients with BMI 30kg/m2 or greater.
       NDA for Saxenda(Liraglutide) was submitted on october 2013 with US FDA. The data submitted for NDA included phase 3 SCALET  clinical trial in which 5000 people with obesity were involved.

Isocratic vs Gradient Mode

Isocratic vs Gradient

In isocratic mode a constant single solvent or constant mixture of solvents are used  in analysis where as in gradient mode the composition of solvents is changed constantly while performing analysis for enhancing the separation efficiency i.e to get faster elution of sample from mixture.

Sink Condition

Sink Condition is the  medium volume that is three times or more greater than the volume required to form a saturated solution. It is used in Dissolution studies

Dialysis treatment- More men receive Dialysis treatment than woman do

Based on international patient data, Meduni vienna and Arbor research collaborative for health USA has highlighted in their publication that fewer women than men receive dialysis treatment for chronic kidney disease even though women suffer more commonly than men from kidney disease.
                               Patient data has been collected in Dialysis outcomes and practice patterns study(DOPPS) since 1996  and subjected to scientific analysis. Total 12 countries involved in analysis ( United States,UK,Canada,France,Germany,Japan,Sweden, Italy,Australia,Belgium,Spain)
                               Overall average of 59:41(Men : Women) was the distribution ratio  This study results are vital as in general assumption more women are effected with kidney disease than men do.

Recognize Stroke - 'FAST'

If you notice any of these warnings of stroke immediately call emergency medical service.

Face- has there mouth dropped ?
Arms-can they lift arms ?
speech-do they have slurred speech ?
Time-critical. Respond quickly as time duration plays life-death role.

Atrial Fibrillation (AF) importance in stroke

Atrial fibrillation,AF is an under treated heart condition which causes the Atria of heart (two chambers of heart,upper) to quiver ( tremble,shake with slight rapid motion) instead of beating effectively.
          This leads to incomplete out pumping of blood , pooling of blood , in turn clotting.These clots can travel to brain and trigger a major fatal stroke Those with Atrial Fibrillation  are at 5 times more risk of stroke than others.

Role of salt in Stroke

Salt raises blood pressure which leads to higher risk of stroke. salt intake should be less than 5 gm a day to lower the risk of stroke in adults and even below 5 gm in childhood as Blood pressure start it raise in childhood..

Reduce risk of stroke - 5 important measures

1.Know your risk factors viz . High B.P,High cholesterol in blood,Diabetes
2. Exercise regularly to stay physically active
3.Limit alcohol consumption,smoking.
4.Be aware of stroke warning signs
5.Diet high in vegetables and fruit and low salt to keep Blood pressure low

Novartis dis-invests influenza vaccine business to CSL for 275 Million USD.

Novartis to dis-invest its influenza vaccines business to CSL ltd for USD 275 million.As this transaction requires regulatory approval,it is expected to close in second half of 2015 .Novartis remains committed to influenza business during the transaction period to closing which also includes honoring agreements with customers ,R&D for influenza vaccines and product launches.
          Earlier , in April 22, 2014 ,Novartis reached a definitive agreement with GSK(Glaxosmithkline) to exchange certain assets , building global leadership in key segments and focusing Novartis portfolio.
 And Novartis announced a definitive agreement with ELI Lilly and Company to divest its Animal health division further focusing its portfolio on leading business of innovative pharmaceuticals , eye care and generics. 

Tosedostat, a novel Anti-Tumour drug

TOSEDOSTAT is an oral aminopeptidase inhibitor that has demonstrated anti -tumour response in blood cancers and solid tumours  in phase 1-2 clinical trials .At present, phase 2/3 is being conducted referred to as AML less intensive(LI-D trial).
         Aminopeptidases are required by tumour cells to provide amino acids necessary for growth and survival .
                Tosedostat is curently being evaluated in multiple phase 2 trials for treatment of patients with Acute Myeloid Leukemia(AML) or high risk Myelodysplastic Syndrome(MDS)

CTI BIOPHARMA, acquires world wide rights to Tosedostat

CTI Biopharma has acquired world wide rights to TOSEDOSTAT through concurrent transactions with Vernalis R&D Ltd and Chroma Therapeutics.Under terms of assets purchase agreement with Chroma Therapeutics , CTI Biopharma acquired Chroma rights,titlle , and interest in TOSEDOSTAT  in exchng for USD 21.3 million in shares to  Chroma Therapeutics.Also CTI Biopharma entered in to license agreement with Vernalis R&D for world wide rights to use IPR(intellectual property rights) and certain patents to develop , market and commercialize TOSEDOSTAT.

Amgen alleges Sanofi and Regeneron Pharmaceuticals infringed its patents , files lawsuit

Amgen filed a lawsuit in US district court of Dalaware against sanofi and Regeneron pharmaceuticals . They allegedly infringed US patent rights with patent numbers 8563698,8829165,8859741. These patents are owned by Amgen which describe and claim monoclonal antibodies to pro-protein convertase subtilisin/kexin type 9 {PCSK9}. With this lawsuit Agmen wants injunction to prevent infringing sale of Alirocumab,a monoclonal antibody targeting pcsk9 from Regeneron pharmaceuticals as they recently announced seeking regulatory approval for marketing alirocumab in US

Drugs for treatment of Asthma

Asthma is long term disease that has no cure . The goal of treatment is to control disease . This control shall result  in prevention of chronic symptoms like coughing , shortness of breath, maintain good lung function .
Long term control medicines :
Inhaled corticosteroids: these corticosteroids are preferred medicine for long term control of asthma. They are most effective option for long term relief .
One common side effect of inhaled corticosteroids is thrush , a mouth infection.
Cromolyn:cromolyn prevents inflammation of airways .It is administered by aid of nebulizer which sends mist of drug to the lungs.
Omalizumab:Omalizumab prevents trigger reactions when exposed to asthma triggers like pollen and dust mites. It is administered as an injection(shot).
Long acting beta2 agonists: They are taken in combination with corticosteroids to improve asthma control as inhalation .These drugs open the blocked airways

Leukotriene modifiers: These drugs block the chain reaction that increases airway inflammation.

Spirometry for Asthma Diagnosis


There is no single precise test to diagnose asthma,hence has to be based on patterns of symptoms and response to therapy over the time.However Spirometry test aids in asthma diagnosis and its management .In this test Forced Expiration Volume in 1 second [FEV1] is measured followed by administration of bronchodilator like salbutamol . If the improvement in FEV1 is greater than 12% it is supportive of diagnosis 

What causes asthma

Asthma is caused by various factors like environmental,genetic,medical conditions .The effect of these factors on Asthma is partially  understood/known
Environmental: The low quality of air due to traffic pollution or high ozone level,smoking during pregnancy ,exposure to indoor allergens like dust mites,cockroaches,mold etc or exposure to indoor volatile organic compounds may trigger Asthma attack.
 Genetic:The genes related to immune system and inflammation modulators which are hereditary is a risk factor for asthma.Some times genetic variations take place when combined with environmental exposures which have role in asthma
Medical Condition:previous history of Atopic disease is a strong risk factor for asthma.and also the asthma attack is high in patients with eczema or hay fever.Obesity has co relationship with asthma.Beta blockers,NSAIDS,Ace -inhibitors ,Aspirin may trigger asthma.

Who are at more risk of asthma? Adults or Children, females or Males ?


Asthma generally affects all  age groups but often starts in childhood.Children who often have respiratory infections and wheeze often are at higher risk of developing asthma.In United States , there are  around 25 million with asthma among which more than 7 million are children.
    When it comes to sex , girls have less asthma than boys which is quite opposite in adults where more women have asthma than men.But as of now, role of sex hormones in asthma is not known.

what actually happens in asthma?(Process)


The airways which carry air into and out of lungs gets inflamed which makes airways  very sensitive and swollen .These sensitive airways react strongly to few inhaled substances(triggers).This reaction leads to muscle tighten around them in turn narrows airways causing reduced air flow to lungs.
                 Also,airways may make more mucus(sticky thick liquid) than normal which further blocks(narrows) air way .All these in a chain might result in asthma symptoms