EMA Backs Record Number of Drugs for Rare Diseases in 2014

The European Medicines Agency (EMA) gave positive opinions on a record number of orphan medicines for rare diseases in 2014.

Of a total of 82 medicines for human use recommended in 2014, 17 are intended for the treatment of a rare disease, "providing therapies for patients who often have only few or no treatment options," the EMA notes in a news release.

For comparison, the agency recommended 11 orphan medicines in 2013, eight in 2012, and four each in 2011 and 2010.

Antibiotic breakthrough may signal the end of drug-resistant superbugs

Scientists have come across a potential game-changer in the fight against drug-resistant superbugs - a new class of antibiotic that is resistant to resistance. Not only does the new compound - which comes from soil bacteria - kill deadly superbugs like MRSA, but also - because of the way it destroys their cell wall - the pathogens will find it very difficult to mutate into resistant strains.

FDA Issues Alert On Bed Wetting Drug

The US Food and Drug Administration (FDA) has asked the manufacturers to update drug labels and prescription information on desmopressin, available in tablet and nasal spray form and used to treat bed wetting, to include new information about severe hyponatremia, a condition caused by insufficient sodium in the blood which leads to seizures and sometimes death.

Desmopressin reduces water elimination via urine, thus preventing excessive thirst, urination and dehydration brought about by a range of conditions such as types of diabetes, physical injury, surgery and other medical conditions.

Children who were being treated with intranasal forms of desmopressin for bed wetting or primary nocturnal enuresis(PNE) were "particularly susceptible to severe hyponatremia and seizures" said the FDA.

Nasal spray formulations that contain desmopressin are no longer approved for the treatment of bed wetting (PNE), said the FDA, and they should not be used in patients with hyponatremia or who have a history of it.

Diagnosing deadly cancers earlier with 'lab-on-a-chip'

A lab-on-a-chip that tests for biomarkers in exosomes – small sacs of messages released by cells, including cancer cells – shows promise as a way to diagnose deadly cancers early.

Batch-25 students of ACRI, gave a very informative, well researched and very good technical group discussion on the topic of ''TRANSLATIONAL RESEARCH".

A Systematic Review of Medical Research

*  Decide which studies to include in the review. The first and most important decision is to decide what research question will be answered. This is expressed as an aim, for example: 'To assess the effects of a new drug for a particular health problem in   certain types of people.'

 *  Decide which studies to include in the review. This will be decided in part by the tightly defined research question, but there are further 'eligibility criteria' that must be decided in advance for the inclusion or exclusion of studies. Typically, all the studies need to be of a rigorous design, such as a randomized controlled trial.

 *  Search for the studies. The sources consulted, and the search terms used to trawl them are outlined for attack - in the case of Cochrane reviews, by specially trained search coordinators. Attempts should also be made in the search to reveal unpublished studies.

 *  Select the studies and collect data from them. Data are extracted from the studies that meet the eligibility criteria set out in advance. The data relevant to the research question being investigated may have to be extracted from varied formats.

 *  Assess the risk of bias in the included studies. This is a process to ensure that all the studies reviewed are relevant and reliable. For example, was the randomization in the trial double-blinded? Or was there a risk of bias over which participants were selected for either treatment or comparison? Some studies may be of a lower quality, but they can still be included, so long as this assessment of bias is taken into account.

 *  Analyze the data and undertake meta-analyses. This is the core process of a systematic review, the main step towards synthesizing conclusions. Researchers are warned not to jump straight into this process of data analysis without first defining the aims and taking the precautions in the above steps.

 *  Address any publication bias. One of the disadvantages of systematic reviews is publication bias, which effectively means study results being cherry-picked. The risk is that a systematic review misrepresents the true effects of treatment, so this step is designed to address that concern.

 *  Present the final results of the review.

- including 'summary of findings' tables. This is the published outcome of the work used by healthcare decision-makers.

Kidney stones may increase the risk of heart disease, stroke

A kidney stone is an accumulation of waste chemicals in the kidney - calcium, oxalate, cystine, phosphate, xanthine and irate - that become a hard mass. Normally, these chemicals are passed out of the body through urine, but they can build up if there is not enough liquid to get rid of them.

Once these stones are formed, they either stay in the kidney or move down the urinary tract into the ureter. Smaller stones can be passed out the body in urine without causing major discomfort, but larger stones may become stuck. Urine can build up behind the stones, causing a lot of pain.

Study results found that patients with kidney stones are at 19% higher risk of coronary heart disease and 40% higher risk of stroke.

Commonly prescribed antibiotic 'could increase risk of cardiac death'

Clarithromycin belongs to a class of drugs known as macrolide antibiotics. It is used to treat an array of bacterial infections, including pneumonia, bronchitis and ear, sinus, skin and throat infections.

According to the research, macrolide antibiotics increase the duration of the heart muscle's electrical activity - known as the QT interval - which can lead to abnormal heart rhythm (arrhythmia), a known risk factor for stroke and sudden cardiac arrest.

Heart failure: transplantation of animal organs into human patients 'more viable'

Heart transplantation is the main treatment for end stage heart failure. Heart patients awaiting a transplant must rely on mechanical devices, which can increase the risk of infection, blood clots and bleeding in the patient.

A proposed alternative has been to use animal hearts in human patients, which is known as "xenotransplantation."

Scientists have reported success in transplanting the hearts from genetically engineered piglets into the abdomens of baboons, where the hearts have survived for more than 1 year. 

Firstly, pigs were genetically engineered to be a source of donor organs. These pigs had human genes that make their organs more compatible with human physiology. Pigs were chosen because their anatomy is similar to human anatomy.

Dear All,

Please find below the workshop brochure. If interested kindly mail us at smitha.p@acriindia.com. Post your confirmation, mode of payment would be communicated to you.

For any queries kindly contact - 08049203 714, 715, 09538872289.

                                                          

ACRI-Clinical Research Institute

#33, 3rd Flr, 15th Cross, 100ft Outer Ring Road,
2nd Phase J.P. Nagar, Bangalore – 560078

www.acriindia.com

WORKSHOP ON BASIC SAS

We are pleased to invite you to a one day workshop on one of the most significant topics – Basic SAS [Statistical Analytical Software] which would be conducted by ACRI in the first week of September, 2014.

SAS training would indeed provide a career with better growth potential and more options in terms of variety of jobs. There is a steady demand for SAS professionals throughout the pharmaceutical industry. It is crucial for Pharmaceutical companies, Biotechs and CRO’s to have SAS expertise from both statistical and data management point of view.

So come one, come all and get the best out of this valuable workshop. 

Kindly confirm your interest by calling 08049203714/715.

FDA OKs Injectable Dantrolene for Malignant Hyperthermia

The US Food and Drug Administration (FDA) has approved an injectable form of dantrolene sodium (Ryanodex, Eagle Pharmaceuticals) for rapid treatment of malignant hyperthermia (MH), along with the appropriate supportive measures.

MH is a potentially fatal inherited disorder triggered by exposure to certain drugs used for general anesthesia, including the neuromuscular blocking agent succinylcholine.

Ryanodex — which can be administered much more quickly than current formulations of dantrolene will be available in single-use vials containing 250 mg of dantrolene sodium in lyophilized powder form. It is formulated for rapid reconstitution and administration in less than 1 minute to patients in MH crisis. "Ryanodex should be administered by continuous rapid intravenous push beginning with a loading dose of 2.5 mg/kg, and continuing until symptoms subside."

EU approves Novartis glaucoma combo

The European Commission has approved the eye drops to decrease elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, for which monotherapy provides insufficient IOP reduction.  

Simbrinza combines two well-established treatments for elevated IOP into one multi-dose bottle, "offering a simplified schedule compared to brinzolamide and brimonidine administered separately," according to Novartis, which, it is hoped, will help tackle current poor adherence rates to therapy.

Drug made from Indian spices to fight hypertension

A recently done study has found out that commonly used Indian spices in soups, curries and rasam, when used in a specific proportion with white lotus petals, can bring down blood pressure.

The study mentioned that Siddha drug 'venthamarai chooranam,' a mixture of cardamom, ginger, cumin seeds, long pepper (thippili), dill (sada kuppi), licorice (adimadhuram) and white lotus petal could bring down blood pressure in rats during laboratory experiments.

The initial results of the drug were found effective on rats and it made healthy changes in the genes, tissues and blood vessels. The herbal medicine will now be put to further animal and human test, before being given to humans. 

ONLINE ACRI

Benefit of taking online courses, and doubtless the most popular one,      

would be that it offers flexibility to students.

The students can attend classes and courses whenever and wherever there is a computer and access to the internet, they can easily plan out a schedule that would work for them. Because of the flexibility offered by online learning, individuals who already have full-time jobs or other commitments are also able to take up courses and get their post graduate diploma certificate online. 

Qualification 

BSc/ MSc/ BAMS/ BHMS/ B.Tech (Biotechnology)/Pharmaceutical Science) /MBBS/ BDS/ B.Pharmacy/ M.Pharmacy

                                                     
                                                       Course Content

Design and Development of Drug                                                      
Preclinical Studies                  

Clinical Research Introduction                  

Clinical Trials                            

Quality, Regulations and Ethics….  

Teaching Mode

• Electronic copies will be shared to students.
• Lecture slides in PowerPoint format, as used for on-campus classes, made available for Online sessions.
• Additional notes arising from on-campus lectures and tutorials will be shared via mail.

Weekly and Monthly Evaluation

• Test paper will be shared with the candidates on weekly basis and Monthly basis.
• A feedback barometer, through which students are enabled to provide anonymous feedback as to how the subject is progressing on a weekly basis.

Additional Features of the course

• E books and SOP’S will be shared via mail to the candidates.
• Recent updates of clinical research will be provided to the students via mail.

System Requirement for Students

• The broad band connection (512kbps and above)
• Head Set
• Link will be sent to the students email id, they have to click on the link and get connected.

Duration - 3 months

Maitry and Aqib of batch-23, gave a good presentation on technical topic of Clinical trial registeries.

Batch-23 students of ACRI, portrayed a very good role-play on the technical topic of clinical research.

Batch-23 students of ACRI portrayed an excellent,creative and a very informative role-play on the technical topic of clinical research.

Batch-23 students of ACRI, gave one of the best technical group discussion on the topic of ''OUTCOME RESEARCH''.

New Diabetes Drug Approved by FDA

A new pill to treat adults with type 2 diabetes has been approved by the U.S. Food and Drug Administration.

Farxiga (dapaglifozin) tablets were approved to improve patients' blood sugar control, in combination with diet and exercise. The approval is based on findings from 16 clinical trials that included more than 9,400 people with type 2 diabetes.

An increased number of bladder cancers were diagnosed among patients who took the drug, so it is not recommended for patients with bladder cance, the FDA said. The most common side effects among patients who took Farxiga were genital fungal infections and urinary tract infections.

The FDA ordered six post-approval studies for the drug. The studies will examine things such as cardiovascular and bladder cancer risk, liver problems, and pregnancy outcomes among patients taking the drug. Two studies will assess the use of the drug in children.

Farxiga is marketed by Bristol-Meyers Squibb Company and AstraZeneca Pharmaceuticals.