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
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.
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
Symptoms of Asthma
Wheezing sound - Listen here
what is asthma ?
Asthma is a chronic lung disease in which inflammation and narrowing of airways occur.This causes recurring periods of wheezing,shortness of breath ,cough and chest tightness.
Genetic and environmental factors may be the cause of Asthma
Genetic and environmental factors may be the cause of Asthma
Elecsys anti Mullerian Hormone (AMH) , a new fertility test for assessment of ovarian reserve for pregnancy
Elecsys anti Mullerian Hormone (AMH) , a new fertility test for assessment of ovarian reserve for pregnancy is introduced by Roche with increased accuracy when compared to conventional methods.
Anti Mullerian Hormone is a vital fertility marker used in health care to assess ovarian reserve levels.This Elecsys Anti-Mullerian Hormone[AMH] blood test can be measured during any day of menstrual cycle which produces standardized results for ovarian reserve assessment in comparison to ultrasound which often depend on clinic or operator person.
This Elecys AMH blood test will be available in all markets accepting CE mark in Latin America,Europe,Asia,Middle east,Africa.
Anti Mullerian hormone is a protein hormone (dimeric glycoprotein) which is structurally related to inhibin and also activin belonging to family TGF-β (transforming growth factor]. AMH is expressed by granulosa cells of the ovary during reproductive years .By inhibiting excessive follicular selection by FSH , it limits the formation of primary follicles.
Guaifenesin AC for Viral infections
Guaifenesin AC is a combination of Guaifenesin(an expectorant*) and Codeine phosphate(an anti tussive*) .This drug is used in treatment of cough and chest congestion due to viral infections like Flu or common cold and other respiratory diseases.
This combination is used only for short term/temporary infections and not for long term breathing problems.
Guaifenesin AC can be administered with 4 to 6 hours intervals. Don not exceed the prescribed dose . When symptoms of over dosing like irregular heart beat, loss of consciousness ,slow or shallow breathing etc are seen contact your doctor immediately
*Expectorant -It increases the amount of hydration of secretions(respiratory) , resulting in more yet clearer secretion and as a consequence lubricating the irritated respiratory tract .
*Antitussive- a cough suppressant
This combination is used only for short term/temporary infections and not for long term breathing problems.
Guaifenesin AC can be administered with 4 to 6 hours intervals. Don not exceed the prescribed dose . When symptoms of over dosing like irregular heart beat, loss of consciousness ,slow or shallow breathing etc are seen contact your doctor immediately
*Expectorant -It increases the amount of hydration of secretions(respiratory) , resulting in more yet clearer secretion and as a consequence lubricating the irritated respiratory tract .
*Antitussive- a cough suppressant
Cough still continues after Viral infection
Post viral Cough is a condition that follows viral respiratory tract infections like Flu or Common cold . This usually happens because the receptors that were responsible for cough stimulation during previous infection are up reugulated and continue to stimulate after the virus is eliminated.
This condition usually goes away on its own . However increase in cardiac activity such as jogging ,running and other related cardiac activities help .
Cough suppressant drugs containing codeine may help .
This condition usually goes away on its own . However increase in cardiac activity such as jogging ,running and other related cardiac activities help .
Cough suppressant drugs containing codeine may help .
Radio Frequency Ablation(RFA) for Lung Cancer treatment
Radio frequency ablation (RFA) is a form of electrical energy and Ablation means killing completely.In Radio frequency ablation electrical energy heats up the the tumour cells and kill them.
In Radio frequency ablation a small probe like a needle goes through the skin of the chest directly in to the tumour.This process is done under computerized tomography(CT Scan) so that it is made sure probe is in exactly correct place . The electrode in the probe creates radiofrequency energy to produce heat and consequently kill/destroy cancer(tumor) cell.The patient will be under anesthesia the whole process.
Radio Frequency Ablaton(RFA) can be employed in patients with early stage non small cell lung cancer, who do not want to have conventional surgery and also for advanced lung cancer where tumour is blocking airway resulting in breathelessness .
Side effects of RA ablation include small discomfort and pain in the treatment area,feel tired , getting air in to chest cavity which usually goes away with no treatment in few days.
In Radio frequency ablation a small probe like a needle goes through the skin of the chest directly in to the tumour.This process is done under computerized tomography(CT Scan) so that it is made sure probe is in exactly correct place . The electrode in the probe creates radiofrequency energy to produce heat and consequently kill/destroy cancer(tumor) cell.The patient will be under anesthesia the whole process.
Radio Frequency Ablaton(RFA) can be employed in patients with early stage non small cell lung cancer, who do not want to have conventional surgery and also for advanced lung cancer where tumour is blocking airway resulting in breathelessness .
Side effects of RA ablation include small discomfort and pain in the treatment area,feel tired , getting air in to chest cavity which usually goes away with no treatment in few days.
Tramadol use in treatment of Pain
Tramadol is used to treat moderate to moderately severe pain . The extended release from of Tramadol is for around the clock treatment of pain.
Tramadol is an opioid analgesic which has two different mechanisms of action(MOA). 1.By binding to μ-opioid receptors. 2.By inhibiting re-uptake of serotonin and norepinephrine ( Neurotransmitters which play important role in mood ).When administered Tramadol is metabolized to O-desmethyltramol which is significantly more potent opioid .
It's analgesic effect initiates 1 hour after oral administration and reaches to peak effect in 2 to 4 hours . Common adverse effects include diziness, nause,vertigo,constipation , headache,vomitting, somnolance.
Tramadol is first developed and marketed as "Tramal"by Grunenthal GmbH ,a German company in 1977 .It is now available with brand names Conzip,Rybix,Ryzolt,Ultram,Ultram ER,ODT.
Dosage:
Tablets 50 mg - Immediate release
Tablets 100,200,300 mg -Extended release
Capsules 100,200,300 mg-Extended release
Chemistry of Tramadol:
Structure:
IUPAC Name:2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexano
Tramadol is an opioid analgesic which has two different mechanisms of action(MOA). 1.By binding to μ-opioid receptors. 2.By inhibiting re-uptake of serotonin and norepinephrine ( Neurotransmitters which play important role in mood ).When administered Tramadol is metabolized to O-desmethyltramol which is significantly more potent opioid .
It's analgesic effect initiates 1 hour after oral administration and reaches to peak effect in 2 to 4 hours . Common adverse effects include diziness, nause,vertigo,constipation , headache,vomitting, somnolance.
Tramadol is first developed and marketed as "Tramal"by Grunenthal GmbH ,a German company in 1977 .It is now available with brand names Conzip,Rybix,Ryzolt,Ultram,Ultram ER,ODT.
Dosage:
Tablets 50 mg - Immediate release
Tablets 100,200,300 mg -Extended release
Capsules 100,200,300 mg-Extended release
Chemistry of Tramadol:
Structure:
 |
| Tramadol stereoisomers |
Moleuclar Forumula:C16H25NO2
Molecular weight:263.4
Mechanisam of action: Tramadol acts by binding to μ-opioid receptors and also by inhibiting reuptake of serotonin and norepinephrine .
RoACTEMRA(Tocilizumab) use in early Rheumatoid Arthritis(RA) approved by EU
RoACTEMRA(Tocilizumab) use in patients with early Rheumatoid Arthritis has been approved by European Commission .This drug is an anti-interlukin6 (IL-6) receptor antagonist monoclonal antibody. Roche and Chugai Pharmaceuticals co developed the RoACTERMA(Tocilizumab).
European Commission approved Tocilizumab based on data from the phase 3 function studies which evaluated safety ,efficacy and prevention of joint damage in Early Rheumatoid Arthritis patients.
After 24 weeks of treatment as a monotherapy or in combination with Methotrexate(Popular anti cancer drug ) ,this drug(RoACTEMRA) met its primary end point where there is more significant improvement in RA patients as compared to Methotrexate alone.
Chemical formula of Tocilizumab: C6428H9976N1726O2018S42
Mechanism of Action : Tocilizumab binds specifically to membrane bound and soluble Interlukin 6 receptors, mIL6 & sIL6 and inhibits IL-6 mediated signalling through receptors.
Adverse effects of Tocilizumab : Respiratory tract infections,hypertension, headache,and nasopharyngitis
European Commission approved Tocilizumab based on data from the phase 3 function studies which evaluated safety ,efficacy and prevention of joint damage in Early Rheumatoid Arthritis patients.
After 24 weeks of treatment as a monotherapy or in combination with Methotrexate(Popular anti cancer drug ) ,this drug(RoACTEMRA) met its primary end point where there is more significant improvement in RA patients as compared to Methotrexate alone.
Chemical formula of Tocilizumab: C6428H9976N1726O2018S42
Mechanism of Action : Tocilizumab binds specifically to membrane bound and soluble Interlukin 6 receptors, mIL6 & sIL6 and inhibits IL-6 mediated signalling through receptors.
Adverse effects of Tocilizumab : Respiratory tract infections,hypertension, headache,and nasopharyngitis
Gilenya( Fingolimod) out standing data to be shown by Novartis at ACTIMS- ECTRIMS
Gilenya (Fingolimod) used in treatment of multiple sclerosis data to be shown by Novartis at ACTRIMS-ECTRIMS meeting in Boston , USA from September 10 to 13 , on how Novartis is redefining Multiple sclerosis treatment goals for patients
According to Novartis, new data to be presented will reinforce the clinical relevance of brain shrinkage (loss in Brain volume ) and highlight the benefit of including it as 4th key measure of Multiple sclerosis in definition of NEDA. and also other analyses will show that patients who have been treated with Gilenya (Fingolimod) were most likely to achieve NEDA based on assessment of these 4 key measures including shrinkage in brain volume than those on placebo.
Gilenya (finglolimod) local and diffuse CNS damage . It prevents cells that cause local inflammation from reaching the brain and also enters CNS(central nervous system) and reduces diffuse damage.
According to Novartis, new data to be presented will reinforce the clinical relevance of brain shrinkage (loss in Brain volume ) and highlight the benefit of including it as 4th key measure of Multiple sclerosis in definition of NEDA. and also other analyses will show that patients who have been treated with Gilenya (Fingolimod) were most likely to achieve NEDA based on assessment of these 4 key measures including shrinkage in brain volume than those on placebo.
Gilenya (finglolimod) local and diffuse CNS damage . It prevents cells that cause local inflammation from reaching the brain and also enters CNS(central nervous system) and reduces diffuse damage.
Novo Nordisk discontinues R&D activities in inflammatory disorders
Research and Development (R&D) activities within inflammatory disorders have been discontinued by Novo Nordisk ,however increasing its efforts in diabetes prevention and treatment.
Surprisingly this announcement follows company's decision to discontinue anti-IL-20 , which used in rheumatoid Arthritis which was company's most advanced compound.
As a result of this discontinuation company expects to incur a non recurring cost of around 700 million Danish Krona in 2014.Company Executive Vice President said that significant unmet opportunities remain within diabetes, including prevention ,obesity and diabetes complications , so in this area they want to further increase R&D efforts.
Surprisingly this announcement follows company's decision to discontinue anti-IL-20 , which used in rheumatoid Arthritis which was company's most advanced compound.
As a result of this discontinuation company expects to incur a non recurring cost of around 700 million Danish Krona in 2014.Company Executive Vice President said that significant unmet opportunities remain within diabetes, including prevention ,obesity and diabetes complications , so in this area they want to further increase R&D efforts.
Talimogene Laherparepvec submitted for MAA to European Medical Agency
Talimogene Laherparepvec , an investigational agent has been submitted for MAA( Marketing Authorisation Application) to the European Medical Agency for the treatment of adults with metastatic Melanoma . The drug is an intra-tumoral injection that is designed to initiate anti tumor immune response.
The randomized, global and open label phase 3 clinical trial evaluating safety and efficacy of Talimogene Laherparepvec data of patients with 3b or 3c melanoma in more than 400 patients.
Mechanism of action of Talimogene Laherparepvrec :
When it is directly injected in to tumor's it replicates inside the tumor cell causing the cell to rupture and die (Lysis)
This ruptured cancer cell can release tumor derived antigen's , along with GM-CSF which can stimulate system wide immune response.
The randomized, global and open label phase 3 clinical trial evaluating safety and efficacy of Talimogene Laherparepvec data of patients with 3b or 3c melanoma in more than 400 patients.
Mechanism of action of Talimogene Laherparepvrec :
When it is directly injected in to tumor's it replicates inside the tumor cell causing the cell to rupture and die (Lysis)
This ruptured cancer cell can release tumor derived antigen's , along with GM-CSF which can stimulate system wide immune response.
Pioglitazone 10 year epidemiology data has been submitted to US FDA and other Regulatory Authorities by Takeda Pharmaceuticals
Pioglitazone containing drugs 10 year epidemiology data has been submitted to US FDA and other Regulatory authorities Takeda pharmaceuticals.This action was a commitment for post-marketing data submission of Piolgitaozne .This study mainly designed to investigate whether patients who received pioglitazone were at an increased risk of bladder cancer.
According to the statistical data findings, there is no significant risk of bladder cancer among patients who were exposed to Pioglitazone.In addition,it was also found that there is no relation between duration of Piogiltazone use and risk of bladder cancer.
Pioglitazone is used in treatment of patients with diabetes mellitus type 2.This drug was first launched in 1999.
According to the statistical data findings, there is no significant risk of bladder cancer among patients who were exposed to Pioglitazone.In addition,it was also found that there is no relation between duration of Piogiltazone use and risk of bladder cancer.
Pioglitazone is used in treatment of patients with diabetes mellitus type 2.This drug was first launched in 1999.
NECTAR-HF trial primary end point results reported by scientific
NECTAR-HF trial primary end point results reported by Boston Scientific .The trial evaluated 96 NHA (Newyork Heart Association) class 2-3 patients with heart failure.They are randomized in 2:1 ratio to treatment or sham.
However, the trial failed to meet pre specified 6 month primary efficacy endpoint of reduction in left ventricular end systolic diameter.
Although patients who received them felt better as assessed by quality of life questionnaire ,application of VNS failed to reveal clear benefits when compared to sham.
However, the trial failed to meet pre specified 6 month primary efficacy endpoint of reduction in left ventricular end systolic diameter.
Although patients who received them felt better as assessed by quality of life questionnaire ,application of VNS failed to reveal clear benefits when compared to sham.
AMPLIFY-EXT trial of Eliquis(Apixaban) shows positive results
AMPLIFY -EXT trial of Eliquis(Apixaban)shows positive results in phase3 trial. This trial evaluated clinical and demographic predictors of all cause hospitalization in patients suffering from VTE,which include DVT and PE.DVT stands for Deep vein thrombosis and PE stands for Pulmonary embolism .
This Phase 3 trial included randomized ,double blinded,placebo controlled , extended treatment (AMPLIFY-EXT) for 12 months .
Out of 2486 total patients,138 patients were hospitalized during this AMPLIFY-EXT trial at least once.
With this 12 month extended treatment of VTE ,and its positive results provides additional support for extended anti coagulation support with Eliquis(Apixaban) in VTE patients .
BMS and Pfizer are the developers of this Eliquis drug.
RYZODEG,(Insulin degludec+Insulin apart) launched in Mexico , first time in World
RYZODEG , combination of Insulin degludec and Insulin apart (70:30) is launched and available in Mexico for the first time in world for treatment of type 2 diabetes mellitus .
As Ryzodeg is a combination product it requires fewer daily injections than administering it in separate basal and meal time insulin. Ryzodog in a multinational trial given two times daily at main meals. showed successful reduction in HbA1c with less risk of hypoglycemia(lower blood sugar).
Type 2 diabetes mellitus is a life long ,chronic disease(metabolic disorder) in which sugar(glucose) level's in blood are high (hyperglycemia) .Due to insulin resistance and lack of insulin , it is characterized by excess thirst,frequent urination and constant hunger)
Novo Nordisk,developer of Ryzodog is a global health care company with headquarters in Denmark.
As Ryzodeg is a combination product it requires fewer daily injections than administering it in separate basal and meal time insulin. Ryzodog in a multinational trial given two times daily at main meals. showed successful reduction in HbA1c with less risk of hypoglycemia(lower blood sugar).
Type 2 diabetes mellitus is a life long ,chronic disease(metabolic disorder) in which sugar(glucose) level's in blood are high (hyperglycemia) .Due to insulin resistance and lack of insulin , it is characterized by excess thirst,frequent urination and constant hunger)
Novo Nordisk,developer of Ryzodog is a global health care company with headquarters in Denmark.
VIMPAT(lacosamide) mono therapy approved by US FDA for treatment in Epilepsis
sNDA (supplemental new drug application) of VIMPAT (lacosamide)an Anti-epileptic drug approved by US FDA as mono therapy in partial onset seizures .
Epilepsy is a chronic neurological disorder,which can occur across all ages,races and genders where in two or more unproved seizures occur at least one day ( 24 hours) apart .
VIMPAT(lacosamide) is available in various forms like tablets,oral solutions or injections .
Mono therapy is the treatment of a disease with a single drug which is opposite to combination therapy(multiple drugs) ,VIMPAT(lacosamide) is already approved in US as adjunctive treatment (with other drugs) for partial onset seizures in 17 years and older.
The adverse reactions seen in mono therapy study were similar to those in combination with others except insomnia which is greater than 2% .
VIMAT(lacosamide) Safety Information
-Suicidal behavior : Including VIMPAT, all Anti -Epileptic drugs (AED's) increase the risk of suicidal thoughts and change in formation of ideas or concepts.Patients under VIMPAT therapy shall be monitored for worsening of depression ,suicidal thoughts.
-Dizziness and Ataxia: VIMPAT may cause dizziness and ataxia and hence patients taking VIMPAT should be discouraged to perform /operate complex machinenary.
Bulk production success for SYN-004 ,a novel Beta lactamase enzyme for Clostridium difficile infections
SYN-004 , an oral beta lactamase enzyme ,which is a synthetic Biologic's proprietary drug helps in prevention of Clostridium difficile (C.difficile) infections.
The initial 750 liters cGMP(current Good Manufacturing practices) production run on FuJifilm's "pAVEway" platform yielded an unprecedented(Novel) 5.5 Kilograms with 95+% purity of SYN-004 API (Active pharmaceutical ingredient) drug,which will be used to support Synthetic Biolgic's phase1 and phase2 trial's and continued R&D studies .
SYN-004 is the first therapy designed to neutralise Intravenous antibiotics in Gut.SYN-004 is intended to maintain the balance of bacterial flora in Gastro Intestinal tract ,also know as "gut microbiome",which in turn will prevent devastating effect's of Clostridium difficile infection .
Clostridium difficile is a multi-drug resistant bacterium that is believed to infect 1.1 million US patients every year.
The initial 750 liters cGMP(current Good Manufacturing practices) production run on FuJifilm's "pAVEway" platform yielded an unprecedented(Novel) 5.5 Kilograms with 95+% purity of SYN-004 API (Active pharmaceutical ingredient) drug,which will be used to support Synthetic Biolgic's phase1 and phase2 trial's and continued R&D studies .
SYN-004 is the first therapy designed to neutralise Intravenous antibiotics in Gut.SYN-004 is intended to maintain the balance of bacterial flora in Gastro Intestinal tract ,also know as "gut microbiome",which in turn will prevent devastating effect's of Clostridium difficile infection .
Clostridium difficile is a multi-drug resistant bacterium that is believed to infect 1.1 million US patients every year.
Evolocumab,a PCSK9 inhibitor filed with US FDA for treatment of high cholesterol
PCSK9 inhibitor,Evolocumab is highly efficient in patients with elevated cholesterol or stations, hetero zygous familial hypercholesterolemia(HeFH), homo zygous familial hyper-cholesterolemia (HoFH),a genetic disorder.
Amgen,the developer of the Evolocumab has filed for US FDA approval .The data filed contains information from ten phase 3 clinical trials performed on 6,800 patients , including more than 4500 patients with high cholesterol.
PCSK9 , is a protein that reduces the Liver ability to remove harmful cholesterol from the blood.
Amgen (AMGN) is an American bio pharmaceutical company headquarters in Thousand Oaks , California.
Amgen,the developer of the Evolocumab has filed for US FDA approval .The data filed contains information from ten phase 3 clinical trials performed on 6,800 patients , including more than 4500 patients with high cholesterol.
PCSK9 , is a protein that reduces the Liver ability to remove harmful cholesterol from the blood.
Amgen (AMGN) is an American bio pharmaceutical company headquarters in Thousand Oaks , California.
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