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.

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.

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.

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. 

Insys Pharmaceutical Cannabidiol(CBD) gets Orphan Drug status for treatment in Glioblastoma muliforme

Insys Therapeutic's Pharmaceutical Cannaabidiol(CBD) gets US FDA Orphan Drug status for treatment of GLIOBLASTOMA MULTIFORME(GBM) .In addition Insys entered in to an exclusive license agreement with CPMCRI,California Pacific medical center research institute to license patent rights related to usage of CANNABINOIDS  for treatment of GLIOBLASTOMA MULTIFORME(GBM).
GBM,glioblastoma multiforme is a most common form of  primary brain tumours and also most aggressive forms of Cancer. Treating glioblastoma is very difficult due to a variety of complicated factors like tumours cells are very resistant to conventional therapies,bran is susceptible to damage with conventional therapy,most of the drugs do not cross BLOOD -BRAIN barrier. etc
Insys is in process of evaluating potenial use of pharmaceutical Cannabinoids in other treatments like in chemotherapy induced peripheral neuropathy,epilepsy,addiction in cocaine,opioids and amphetmaines.

Latest update :Insys therapeutics will present at the Morgan Stanley Global Healthcare Conference 2014 to be held fro September 8 to 10 at Grand Hyatt ,New York. Michael L. Babich ,president and CEO ,Darryl Baker (CFO) will host the presentation.

Zorvolex(dicofenac) for management of Osteoarthritis(joint disorder) from Iroko Pharma gets US FDA approval

Zorvolex(dicofenac) for management of Osteoarthritis(joint disorder) from Iroko Pharma gets US FDA approval.Zorvolex(diclofenac) is developed with proprietary SoluMatrix FINE PARTICLE TECHNOLOGY  in which diclofenac is in submicron particles form that are approximately 20 times smaller than original size.This reduction in particle size results in increased surface area which leads to faster dissolution , prompt effect.
According to Iroko Pharma, Zorvolex was developed keeping in line with recommendations from US FDA and others that NSAIDs be used in lowest effective dose for short possible duration with individual patient treatment goal.

Arnuity Ellipta approved for used in Asthma treatment

Arnuity Ellipta of GlaxoSmithkline has been approved by US FDA for maintenance treatment  of Asthma as prophylactic therapy in 12 years or older patients.
Arunity Ellipta (fluticasone furoate ) is an inhalation powder which is a once -daily inhaled corticosteroid medicine with doses of 100 mcg and 200 mcg. 
However,it is not indicated for relief of acute bronchospasm.