BGB-3111 phase 1 study initiated for cancer treatment

BGB-3111,an investigational drug phase 1 clinical study for Cancer treatment is initiated by Beigene , a innovative Oncology company . BGB-3111 is an highly selective , potent inhibitor of Bruton Tyro Kinase (BTK) which is a critical component of B-cell(B-lymphocyte) receptor signalling.
       Phase 1a dose escalation part of stud will be performed at fours sites in Australia,which is followed by a phase 1b expansion phase.
BTK is also known as tyrosine-protein kinase BTK . it is an enzyme that is encoded in human beings as "BTK gene".BTK plays  crucial role in B-lymphocyte development.

Xalkori and Pemrolizumab comination to be explored in Lung cancer(NSCLC)

Xalkori(crizotinib) of Pfizer and Pemrolizumab of Merck combination dug potential to be explored in phase 1 clinical study in which the Safety and Tolerability  of this combination in patients with ALK+  advanced or metastatic non -small cell lung cancer (NSCLC) is to to evaluated.
                  Individually , Crizotininb(Xalkori) inhibits an abnormally activated enzyme in patients with ALK+ metastatic lung cancer , and pembrolizumab (investigational drug) harnesses body immune system to fight Cancer. Permbrolizumab exerts dual ligand blockade of Programmed cell death protein 1(PD-1) on T lymphocytes(T-cells) with its ligands PD-L1 and PD-L2.

ZMapp shows positive results in Animals

A recent study by researchers as reported in Nature ZMapp  use in Rhesus macques resulted in 100 percent recovery following treatment with the drug  after infection .ZMapp ,is developed by Mapp Biopharmaceuticals which gained exposure after it was used to treat Dr.knet brantly and Nancy writebol , 2 doctors from USA who showed sings of recovery after receiving the drug ,ZMapp after getting infected with Ebola virus in Liberia.

              ZMapp acts as a cocktail of monoclonal antibodies that bind and inactivate the Ebola virus by recognizing the infected cells and stimulate the immune system to attack and kill them

              According to the study ,a research team administered 3 doses of the drug at three day intervals  starting on 3/4/5th day after infection with virus. Surprisingly all the animals showed reversal of symptoms of Ebola virus(rashes,excessive bleeding etc).Those animals which were not given ZMapp died from infection by day 8.

Chemistry of Jardiance(Empagliflozin)

Chemical Name:D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3furanyl]oxy]phenyl]methyl]phenyl]- (1S)

Molecular Forumula : C23H27CLO7

Molecular weight: 450.91

Chemical Structure:

Appearance:White to Yellowish,non-hygroscopic powder

Solubility:Soluble in water,sparingly soluble in methanol,slightly soluble in Ethanol and Acetonitrile,soluble in 50% acetonitile/water,practically insoluble in Toluene.

Jardiance(Empagliflozin) , new Type-2 antidiabetic drug block by NICE in UK

Empagliflozin , marketed as Jardiance  is a drug used in treatment of type-2 diabetes which acts by inhibiting Sodium Glucose co-transporter  (DGLT-2) .This drug blocks the reabsorbption of glucose in kidneys and hence pass out of the body in urine.it is administered through oral route and once-daily medication.
NICE ,  National Institute for Health and Care Excellence rebuffed ,asked  Boehringer  for new analysis and comparisons with available treatments and revised look at cost -effectiveness.According to NICE there is a good evidence to show Empagliflozin is clinically effective in type-2 diabetes but there is a need for more inforamtion to demonstrate its cost -effectiveness when compared with other treatments that NHS already provides.
On the other hand in United States , Jardiance already hits stores .Eli Lilly and Boehringer Ingelheim are the manufacturers of Jardiance.

More :Chemistry of Jardiance(empagliflozin) 

Aripiprazole Lauroxil,a Novel Drug of Alkemers has been submitted for NDA with US FDA

Aripiprazole Lauroxil,an Alkermes novel Drug  has been submitted for NDA (New Drug Application) approval from US FDA for use in treatment of Schizophrenia.Aripiprazole Lauroxil is an injectablee drug with one-month & two -month  formulations as an anti-psychotic for treatment of Schizophrenia.Aripiprazole lauroxil gets converted to Aripiprazole once administered in to the body,which is a long acting drug based on a unique , Akemers Propietary LinkeRX technology .

                        The positive results from pivotal phase 3 clinical study assessing the efficacy and safety studies in which this novel drug showed significant improvement of schizophrenia compared to placebo.

Chemistry of Aripiprazole Lauroxil

    Molecular Formula : C36H51Cl2N3O4
    Molecular Weight :660.71
    IUPAC name:[7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-2-oxo-3,4-dihydroquinolin-1-yl]methyl dodecanoate

   Chemical Structure:

                                   

Promacta (eltrombopag) sNDA of GlaxoSmithKline gets US FDA approval for treatment in Severe aplastic anaemia

Promacta(eltrombopag)  once daily use drug for use in patients with Sever Aplastic Anaemia(SAA)  who do not respond sufficiently to Imuunosuprresvie therpay(IST) is developed by GSK and gets sNDA approval from United States Food and Drug Administration(US FDA) .Earlier Promacta  gained breakthrough therapy desigantion status in January '14.
Sever aplastic Anaemia is a serious blood disorder  where the bone marrow fails to generate enough new Red and White Blood cells and Platelets. 300 to600 new SAA cases are reported every year in United States of America (USA)
Eltrombopag is a small molecule agonist of the c-mpl (TpoR) receptor, which is the physiological target of the hormone thrombopoietin

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.

New PD-L1(SP142) monoclonal IHC Antibody launched by Spring

PD-L1(SP142) monoclonal Immunohistochemistry Antibody of rabbit is launched by Spring Biosciences for use in  research  of various types of tumours. Measuring  the amount of PD-L1  protein  expressed on tumour cells of cancer might help in assesing the efficacy as well as durability of upcoming investigational  drugs that inhibit the binding PD-L1 protein.
According to Spring ,Internal comparative studies performed shows PD-L1(SP142) antibody outperformed present commercially available PD-L1 antibodies, which would help researchers in assessing PD-L1 status in tissue samples with a high quality and accuracy .

Cerdelga((Eliglusta),a novel drug of Genzyme approved by US FDA for Gaucher Type 1 disease

Cerdelga(eliglustat), a new drug has been approved by US FDA (Food and Drug Administration) for long treatment of adult patients with Type 1 Gaucher , a rare genetic disorder in which fatty substances (sphingolipids) accumulate in cells and certain organs due to lack of an enzyme called glucocerebrosidase.
Ceredelga , a hard gelatin capsule contains the drug Eliglustat .When administered orally it inhibits metabolic process that causes production of fatty materials .The most observed side effects of this drug observed during clinical trials process were fatigue,nausea,headache,diarrhea,abdominal pain.
Ceredelga has also recived "orphan drug "designation fro the FDA .It is manufactured by Genzyme after a Clinical development program which is the largest ever conducted in Gaucher disease,with aroud 400 patients treated in 29 countries.

Depo-Medol(methylprednisolone acetate) ,of Pfizer recalled after it fails pH testing

Depo-Medrol(methylprednisolone acetate ) ,manufactured by Pfizer has to recall 94,000 vials of 40mg/ml single dose vials as they failed pH  specification testing at months where  the result obtained was 2.9  contrary to registered specification  pH 3.0 -7.0.They are recalled voluntarily nation wide.

Palbociclib Expanded Access Program (EAP) in US

Palbociclib Expanded access program(EAP) is initiated by Pfizer in USA for investigational CDK 4/6 inhibitor.With this programme Palbociclib in combination with letorozole is made available for women withHR+( Hormone receptor positive), and HER2-(Human epidermal growth facotr receptor 2 negative) advanced breast CANCER for whom this letrozole is considered as appropiate therapy/treatment.
Pabociclib when administered orally,it selective inhibits CDK's 4 and 6 (cyclin dependent kinase)to regain cell cycle control and will block further cell proliferation.

Eliquis sNDA has been approved by FDA for treatment in DVT and PE

Eliquis  Supplemental New drug application,sNDA has been approved by the US FDA for treatment of DVT and PE(Blood clots ) and for reduction of risk of Recurrent DVT and PE after initial treatment(therapy)
DVT is blood clot in vein,generally in lower leg or thigh or pelvis which causes partial or complete halt of blood flow in these regions.PE is blood clot in one or more LUNG vessels ,blocking them.DVT progresses to PE if left untreated. DVT and PE together are called VTE.
Eliquis ,(Apixaban) is an oral selective Factor Xa inhibitor,an important blood clotting protein.By inhibiting this it decreases blood clot formation.

TAVI treatment planning application clears US FDA 510(k)

TAVI(Trans catheter Aortic Valve Implantation) precision treatment planning application has received US FDA 510(k) clearance.This application is developed by Roayal Philips.

            This TAVI planning applications using 3D imaging will provide interventionalists with high precision positioning to treat Aortic stenosis ailments .With advanced computed tomography imaging ,it provides  planes and panel measuremnts for precisely placing TAVI device to manage risk of under or over sizing of the device.

This TAVI planning Application is available as a part of Royal Philips IntelliSpace portal6  which is the company's advanced visualisation and analysis solution that allow  access and analyze patient imaging and data virtually anywhere at any time.

         510(k)  is a section of  Federal Food ,drug and cosmetics act which requires those device manufacturers who must register  to notify FDA, at least Ninty days(90 days) in advance of their intent to market a Medical Device.This is also known as PREMARKET NOTIFICATION.

NOTE:Any device that reaches market via  510(K) process is not considered to be approved by the FDA . However, it can be marketed and sold in US.

Aspirin double use offer - New study

According to a new study Aspirin,a NSAID populary used as pain killer has another hidden use  of resolving Inflammation.The study published in PNAS suggests Aspirin along with prevention of pain causing compounds also triggers cyclooxygens to make trace amount of related compound 15-HETE,which can be converted by a second enzyme into lipoxin , which is known to reverse the inflammation.
Note:As you know,Aspirin inhibits the enzyme Cyclooxygenase which plays major role in production of prostaglandins , which cause arthritis, headache and many other ailments

cefotoxime injection Adverse drug reaction led to death in India

Cefotaxime injection has reportedly caused death of a 47 year old lady in Maharasthra(India) after suffering Adverse Drug Reaction(ADR).Maharasthra FDA officials instructed Stokists and Hospitals to stop use of Cefotaxime injection manufactured under Brand named "Sancocef"  manufactured by Sanjivini parenterals Ltd  . In an official statement the firm stated that use of ceftriaxone injection with that Batch number will be stopped as a precautionary measure untill investigation is complete.
A 3 member committee consisting of a physician,clinical pharmacologist,and a microbiologist  has been constituted to investigate the cause of that Adverse Drug Reaction .

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.

GAL-021 , a novel agent reverses respiratory depression while maintaining pain relief in opioid use

GAL-021, an investigational agent of Galleon pharmaceuticals has been shown to reverse opioid induced respiratory depression while maintaining pain relief in clinical trials .
Opiod Drugs like Methadone,Fentanyl  which are commonly used to manage Pre-operative and Post -operative (surgery) Pain are associated with increased risk of adverse effects like respiratory depression.To treat this Drugs like Naloxone are prescribed ,but they counteract Analgesic effect of opiods which is the worst case of pain .Where as , GAL-021  witout effecting Analgesic activity  prevents respiratory depression while uisng opiods. 
This study is published in a  recent Anesthiology issue .