PHARMA WISDOM

Tuesday, 15 December 2015

Natco, Hetero Generic Pharma makers Get DCGI Nod to Sell Hepatitis-C (HCV) Drug

15 DECEMBER 2015

Hepatitis C virus (HCV) causes both acute and chronic infection. Acute HCV infection is usually asymptomatic, and is only very rarely associated with life-threatening disease. About 15–45% of infected persons spontaneously clear the virus within 6 months of infection without any treatment.

The remaining 55–85% of persons will develop chronic HCV infection. Of those with chronic HCV infection, the risk of cirrhosis of the liver is 15–30% within 20 years.

Daclatasvir is the first-in-class NS5A inhibitor used in combination with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection.

Two city-based drug makers Natco Pharma and Hetero said they received approval from the Drugs Controller General of India (DCGI) to sell generic version of Daclatasvir, used for the treatment of chronic hepatitis C.

“It is the first company in India to get approval for generic Daclatasvir Dihydrochloride (Daclatasvir) tablets, 30 mg & 60 mg, from the Drugs Controller General (India),” Natco said in a disclosure with the bourses.

“The company has received the approval from Drug Controller General of India for the generic version of Daclatasvir tablets in the strengths of 30 mg and 60 mg,” Hetero said.

Natco said it will launch immediately in India at `6,000 and `4,000 for the 60 mg and 30 mg strengths, respectively, for a bottle of 28 tablets.

“Compared with other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult-to-treat HCV patients subsets,” Natco said adding that it will market generic Daclatasvir under its own brand ‘NATDAC,’ and through its strategic partners in India.

This product is a generic version of Bristol-Myers Squibb's brand 'Daklinza' - approved by US FDA in July 2015. Daclatasvir is one of the direct-acting antivirals for hepatitis C treatment. A research study indicates that the drug enables the rapid decline of Hepatitis C virus.

Daclatasvir is included the World Health Organization's List of Essential Medicines.

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Hetero’s ‘First Indian Company’ to Receive DCGI Nod to Treat Hepatitis C

PUBLIC HEALTH

Pharma Wisdom Jobs 08:17:00 0

Hetero, one of India’s leading generic pharmaceutical companies and one of the world’s largest producer of anti-retroviral drugs, announced that it is the first company in India to receive the approval for the fixed-dose combination ledipasvir-sofosbuvir (90mg/400mg) from Drug Controller General of India (DCGI). Following the non-exclusive licensing agreement signed with Gilead Sciences in September last year, to manufacture and market chronic hepatitis C medicines, Hetero is all set to launch the fixed-dose combination therapy ‘ledipasvir-sofosbuvir’ for the Indian patients. The product will be available under the brand name ‘Ledisof’ in India.

Hetero is the first company in India to receive the approval for the fixed-dose combination Ledipasvir-Sofosbuvir (90mg/400mg) from Drug Controller General of India (DCGI), the company said in a statement.

The drug, Ledisof, is a generic version of Gilead Sciences’ brand Harvoni which is approved by the US FDA.

The Hyderabad based Hetero had singed a non-exclusive licensing agreement with Gilead in September last year to manufacture and market the drug indicated for the treatment of chronic hepatitis C and is the first company to receive DCGI approval for this category of drug.

Sofosbuvir in combination with ledipasvir has shown to have high cure rates of around 90 per cent.

Hepatitis C is a growing public health concern, particularly in developing countries. In India alone, it is estimated that 12-18 million patients are infected with hepatitis C which is several fold greater than those with HIV/AIDS.

Untreated chronic hepatitis C increases the risk of cirrhosis of liver, liver failure and hepatocellular carcinoma.

Dr. BPS Reddy, CMD, Hetero group of companies commented, “We have been the front-runners in launching the generic sofosbuvir in several countries. We are now happy to extend the fixed-dose combination therapy ‘ledipasvir-sofosbuvir (Ledisof) to Indian patients, which is much more effective than sofosbuvir. With the launch of Ledisof, we look forward in bringing a paradigm shift in hepatitis C management in the country.”

GPAT-2016 Tips and Tricks

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Pharma Wisdom Jobs 19:28:00 2

GRADUATE PHARMACY APTITUDE TEST (GPAT) is a national level entrance exam conducted by All India Council for Technical Education (AICTE) every year as per the directions of Ministry of Human Resource Development (MHRD), Government of India. This test facilitates institutions to select suitable Pharmacy graduates for admission into the Master’s (M.Pharm) program. The GPAT is a three hour computer based online test which is conducted in a single session. The GPAT score is accepted by all AICTE-Approved Institutions/University Departments/Constituent Colleges/Affiliated Colleges. A few scholarships and other financial assistance in the field of Pharmacy are also given on the basis of the GPAT score. The GPAT 2016 will be conducted on 17th January 2016.

GPAT 2016 – Online examination tips and practice for success:

GPAT 2016 is an online examination. This is computer based online test which is conducted in a single session and hence you might feel anxious about the exam. Here are some tips to help you succeed in the online GPAT exam.

Practise, Practise and Practise for GPAT 2016

You cannot have a clear understanding of the level of your preparation, unless and until you test yourself. By giving as many tests as possible, more so in the last one month before the exam will definitely help you in improving your final score.

The actual GPAT exam (Dated: 17/01/2016)

You need to be smart when you are actually attempting the exam. All the hard work you have put in will go in vain, if you fail to finish the exam on a positive note. You cannot afford to lose at the last moment. The pain and agony associated with failure after thorough preparation is unbearable. Therefore, you must bear the following points in your mind while you are taking the exam.

1. You have 180 minutes to complete the test. Use each and every second of this time.

2. Do not waste your time on questions which confuse you. You have the option of marking the questions for REVIEW which you can visit later.

3. Keep navigating through the questions and answer those questions first, which are easy and have direct answers.

4. Follow the deletion method wherever possible. If you are fortunate enough, you may come across at least 10-15 questions where you can find the correct answer by omitting the wrong answers if you are sure of them.

5. Try to solve questions which have mathematical calculations in the first two hours. This will give you enough time to avoid calculation mistakes.

6. Remember that there is NEGATIVE MARKING. You must avoid answering questions which are too difficult or from the topics you have not covered. It does not matter how many questions you attempt. All that matters is how many questions you have answered CORRECTLY. So try to avoid the tendency to answer all questions and rely on luck!

7. Lastly, allot at least 10 min time to review all the unanswered questions and mathematical questions. This will ensure that you check these questions twice and reduce the scope of mistakes.

We would be glad to help you if you have any queries. Keep watching this space for more updates about GPAT 2016 preparation.

PLANNING FOR SUCCESS – GPAT 2016 SUCCESS MANTRA

With the date of GPAT 2016 (Jan 17 ^th) fast approaching, there is a feeling of anxiety among the final year students about clearing the exam. Since last year, GPAT has gone online and the level of difficulty has also been increased considerably. It is astonishing as well as disappointing to know that there are a number of students who do not even know the importance of GPAT. Those who understand the importance are plagued by the tension of clearing the exam in the first attempt. The burden of project work in final semester, lack of time to prepare and no proper guidance provided in colleges adds to the agony of many GPAT aspirants. This discussion throws some light on how one can plan their approach to clear GPAT in the first attempt with a good score. This in fact, applies to all other competitive exams like MANIPAL-ENAT, NIPER-JEE, and BITSAT.

So the important ingredients for success in GPAT 2016 and your subsequent admission to NIPER or University Colleges is planning and smart work.

STUDY PLAN FOR GPAT 2016:

Organizing your study time and planning what to study when is a very important aspect for GPAT preparation. Most of the students find it difficult to manage their time and end up feeling tensed and worried at the last moment. It is to be remembered that proper planning and allocation of time for studies is very crucial in deciding your performance in the main exam.

Let us look at some important points which should be addressed while preparing a plan of action for GPAT preparation.

SYLLABUS SORTING:

Finishing the entire syllabus of four years in 2-4 months is foolish and impossible to accomplish. Instead of wasting your time on topics and subjects which are least likely to be asked in the exam, you must try to complete as many topics as you can, from subjects which are given more importance and weightage in the main exam. Even in these subjects, you need not go through the entire syllabus that is prescribed as in case of Pharmacology, Pharmaceutical Chemistry, Pharmacognosy and Pharmaceutical Analysis. These subjects are very vast and it is practically impossible to cover all the topics that are mentioned in the GPAT syllabus in such a short time of 2 months. Therefore, you must try to sort the topics that are more important and cover them first. To do this, you can do the following:

Compare the syllabus of your university with the official GPAT syllabus and underline the common topics. These are the topics which will require more concentration while you study.

Refer books which have papers from previous exams and try to get the idea about the general tendency of questioning from a particular subject/topic. This will help you not only to identify important topics but also acquaint you with different types of questions that can be asked from the same topic.

Once you have prepared a list of topics for a given subject, start studying your favorite subject first to get into the groove. Start making your own notes, preferably point-wise so that you can easily refer it in the last week before the exam.

TIME ALLOCATION FOR GPAT PREPARATION

It is really a tough task to squeeze out time to prepare for a competitive exam, especially when you have to attend college regularly. However, it is not that difficult, provided you are ready to forego some luxuries and are determined to follow a schedule.

Assuming that you attend college every day for 8 hours (9 to 5) and it takes 2 hours for your journey to college and back home. You are still left with 14 hours every day! Make the most of this time. Make it a habit to wake up early in the morning instead of staying up late night. The ideal time to study for such important exams is from 5-8 a.m in the morning. After you are back from college, take a break for an hour and get back to studies. You can wrap up your day by 11 p.m which means that you study at least 7 hrs (3 hrs morning + 4 hours evening) a day initially. As the exam date nears, you can increase your study time by a couple of which is more than sufficient in the last 15 days.

For those interested in admission to post-graduate Pharmacy courses such as M Pharm, it’s time to study for the Graduate Pharmacy Aptitude Test (GPAT) 2014, conducted by All India Council for Technical Education (AICTE).

When competing for admissions at national-level, studying may become more stressful, here are some tips and tricks to help you prepare!
PAPER PATTERN:
The computer based GPAT 2016 exam consists of 125 multiple choice questions to be completed in 3 hours. Correct answers are worth 4 marks each and negative marking of -1 mark for each incorrect answer is applicable.
The exam is broadly based on 4 topics:
1. PHARMACEUTICS
Important topics include: Introduction to Physical pharmacy, Importance of microbiology in pharmacy, Introduction to pharmaceutical jurisprudence & ethics, Introduction to dispensing and community pharmacy, Importance of unit operations in manufacturing, Dosages Forms, designing & evaluation, Biopharmaceutics & Pharmacokinetics.
2. PHARMACEUTICAL CHEMISTRY
Important topics include: Inorganic pharmaceutical & medicinal chemistry, Physical Chemistry and its importance in pharmacy, Organic Chemistry and its importance in pharmacy, Biochemistry, Medicinal Chemistry, Pharmaceutical Analysis.
3. PHARMACOLOGY
Important topics include: Immunopathophysiology, Pathophysiology of Common Diseases, Fundamentals of general pharmacology, Pharmacology of Peripheral Nervous System, Drugs Acting on the Hemopoietic System, Autacoids, Drugs Acting on the Respiratory System, Gastrointestinal Tract, Pharmacology of Endocrine System, Chemotherapy, Principles of Toxicology, Basic Concepts of Pharmacotherapy.
4. PHARMACOGNOSY
Important topics include: Sources of Drugs, Crude Drugs, Systematic Pharmacognostical study, Steroidal, Purines, Studies of Traditional Drugs, morphology, chemical nature of chief constituents, pharmacology, categories and common uses and marketed formulations of indigenous drugs, General Techniques of Biosynthetic Studies and Basic Metabolic Pathways/Biogenesis, Glycosides, Role of plant-based drugs on National economy.

Tips:

1. Clear your basic concepts from your B Pharm text books before you use additional study material.

2. Study ALL topics given in detailed syllabus apart from important topics.

3. Use topic-area charts for quick revision.

4. Pay attention to details as most often questions are based on specific points.

5. Remember names of drugs, ingredients etc by using mnemonics.

6. Practice sketching molecular structures, it will help you remember them easily.

7. Group study is helpful for GPAT preparation; you can quiz each other with Multiple Choice Questions.

8. Although the GPAT examination is based on Multiple Choice Questions practice writing answers in your own words. This will help you check your understanding of the topic.

9. Practice numerical, although there are not many numerical problems in exam paper, regular practice will score you easy marks on the 3-4 numerical questions that do come in the question paper.

10. The most effective way to prepare is by practicing sample papers/previous year papers.

11. Attempt all the questions when you practice sample papers/previous year papers and correct them after you complete the entire paper. This will help you identify your weak areas and you can study those areas thoroughly.

12. During the exam skip any question you are not sure of to avoid negative marking.

We hope that this discussion will help you in making a proper plan to prepare for GPAT.

Detailed syllabus is available at: http://www.aicte-gpat.in

Download syllabus book click hear

Super veggies: Potatoes, onions keep stomach cancer at bay

PUBLIC HEALTH

Pharma Wisdom Jobs 21:56:00 0

Vitamin C in white vegetables like potato acts as an antioxidant to cut down cellular stress in the stomach and it also fights a bacterium responsible for causing gastric cancer.

Scientists have discovered that eating potatoes and cabbage can help reduce the risk of developing stomach cancer.

It found that people who eat a large amount of white vegetables, such as onions and cauliflower, were a third less likely to develop it than those who did not eat them.

But the risk was increased through beers, spirits, salt and preserved food.

The study was conducted by scientists at Zhejiang University in China.

It used 76 existing studies into diet and stomach cancer which have involved 6.3m people being surveyed and 33,000 deaths from the disease.

It found that for every 100g of fruit someone eats daily the risk of developing stomach cancer is reduced by fiver per cent, the risk was reduced to eight per cent for every 50mg of vitamin C - the equivalent of two potatoes.

Whereas salt increased the risk by 12 per cent.

Former nurse weaves princess wigs for children undergoing chemotherapy Stomach cancer kills around 13 people every day in Britain and has just a 15 per cent 10 year survival rate.

Cabbage, kale and celery were also found to be preventives against the disease.

All of the vegetables are thought to contain vitamin C, commonly found in potatoes, which acts as an antioxidant against cellular stress in the stomach. Eating around 50g of the vitamin every day brought the risk of developing the disease down by eight per cent.

Scientists estimated for every 100g of fruit eaten daily the risk of cancer decreased by an average of five per cent.

Vitamin C is thought to be the key nutrient, which acts as an antioxidant to cut down cellular stress in the stomach as well as fighting a bacterium responsible for causing gastric cancer. The scientists analysed 76 best studies on diet and stomach cancer, which involved more than 6.3 million people and almost 33,000 deaths from the disease, The Times reported.

"Both fruit and white vegetables are rich sources of vitamin C, which showed significant protective effect against gastric cancer by our analysis."

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Researchers develop new sensor that can detect estrogen levels in body fluids

PUBLIC HEALTH

Pharma Wisdom Jobs 21:28:00 0

Researchers develop new sensor that can detect estrogen levels in body fluids

A schematic shows the new sensor that can detect low levels of E2, one of the primary estrogen hormones, in liquids.Image Credit: Victoria University of Wellington

Researchers have developed a new sensor that could detect levels of estrogen in body fluids like saliva or test for hormone contamination in waterways.

Estrogen is one of the main hormones that regulates the female reproductive system - it can be monitored to track human fertility and is sometimes administered to livestock to control the reproductive cycle. Researchers from the Victoria University of Wellington in New Zealand developed the sensor that can detect low levels of E2, one of the primary estrogen hormones, in liquids.

The sensor sends an electronic signal in the presence of estrogen and, with further development, could test estrogen levels in body fluids or test waterways for estrogen contamination that might pose a risk to humans and the environment.

The sensor has a simple design, gives real-time readings, could be integrated into an electronic monitoring system and uses very little power - advantages it has over other types of detection methods. The device uses small snippets of DNA called aptamers to latch onto estrogen molecules.

"Aptamers are a potentially powerful tool for sensors because they are so versatile and selective," said Natalie Plank, a researcher at the Victoria University. Aptamers are developed through a process similar to natural selection. From a diverse starting population of different DNA or RNA nucleotide sequences, the ones that bind best to the target molecule are selectively enriched, and the process is repeated over multiple "generations."

Once the appropriate sequence of nucleotides is known, the aptamers can be easily generated. The researchers attached their estrogen-binding aptamers to the carbon nanotube thin film field effect transistor (CNT FET). CNT FETs work like traditional transistors, but use carbon nanotubes instead of silicon. They then tested two different estrogen-binding aptamers - one that was 35 units long and another that was 75 units long.

The researchers found that in the presence of estrogen the short aptamer device produced an electrical signal, while the long aptamer device did not. When the buffer is placed on top of the CNT FET, the voltage across the device causes the molecules in the buffer to arrange into an electrically stable bilayer above the transistor.

Estrogen molecules that are caught by the short aptamer disrupt this layer, which in turn changes the current through the device. Estrogen molecules caught by the longer aptamer are likely held above the bilayer, and so do not create the electrical signal.

The study was published in Journal of Vacuum Science and Technology B.

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Government launches injectable vaccine to prevent polio re-emergence

PUBLIC HEALTH

Pharma Wisdom Jobs 21:22:00 0

Union health minister JP Nadda with MoS for Ayush Shripad Yesso Naik launched the Inactivated Polio Vaccine (IPV) in New Delhi on Monday. (PTI)

In the wake of re-emerging polio, the government launched an injectable vaccine on Monday to be administered in addition to polio drops to double the protection from the deadly virus which has chances of coming back.

The inactivated polio vaccine (IPV) will be introduced in the routine immunisation programme of the government to do away with the risk of re-introduction of the disease. Health minister JP Nadda said that though India was certified polio-free on March 27, 2014, the battle against polio is not over yet.

“The virus is still active in our neighboring countries --Pakistan and Afghanistan. Cases of polio still happen there. So the risk of re-introduction of the disease remains, particularly through importation from these endemic countries,” he said.

“We are there to give them all kinds of support including technical, experience or vaccine-related assistance. But we will have to be vigilant till the virus is eradicated globally,” Nadda said at a function here to launch the vaccine.

“To ensure that our children are doubly protected from polio, the IPV is being introduced into the routine immunisation programme,” he said

In the first phase, the IPV injection is being introduced in six states - Assam, Bihar, Uttar Pradesh, Gujarat, Madhya Pradesh and Punjab.

However, the children will continue to receive OPV (polio drops) dose under routine immunisation and in pulse polio campaigns till they are 5 years of age.

“Even after receiving the IPV vaccine with the third dose of OPV (polio drops), the children must continue to receive OPV doses under routine immunisation and in pulse polio campaigns till they are five years of age,” health secretary BP Sharma said.

He said with the elimination of Type 2 polio from the country, the government is shifting from tOPV vaccine to bOPV vaccine in April 2016 and the introduction of new vaccine IPV in the immunization programme will reduce the risk associated with the shift.

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New test may improve diagnosis of pancreatic cancers

PUBLIC HEALTH

Pharma Wisdom Jobs 23:07:00 0

New test may improve diagnosis of pancreatic cancers...

A 19-gauge EUS-FNA needle was advanced transhepatically into the portal vein and 2-4 aliquots of 8.5 mL of blood were aspirated. Image Credit: University of Chicago Medicine.

Scientists have developed a noninvasive, feasible and safe method to detect tumour cells in the pancreas and bile ducts, which could lead to early diagnosis for pancreatic cancer.

By collecting samples from the portal vein - which carries blood from the gastrointestinal tract, including from the pancreas, to the liver - physicians can learn far more about a patient's pancreatic cancer than by relying on peripheral blood from a more easily accessed vein in the arm, researchers from the University of Chicago in US have found. Primary tumours shed cancerous cells, known as circulating tumour cells (CTCs), into the blood. These have been widely studied as prognostic biomarkers for various cancers.

Since these cells are often larger, irregularly shaped and tend to cluster together, they get trapped in smaller vessels. The researchers hypothesised that most cells released from a gastrointestinal tumour would flow into the portal vein and then get sequestered by the narrow vessels in the liver. These cells would not reach the peripheral venous system.

CTCs from gastrointestinal tumours are rarely identified in the peripheral blood until the cancer is widely metastatic. To test this theory, researchers used an ultrasound-guided endoscope and a small needle to take blood from the portal vein during routine diagnostic endoscopies. They found CTCs in 100% of 18 patients with suspected tumours in the pancreas and bile ducts. Tests using peripheral blood samples, the standard method, detected tumours cells in only four of the 18 patients.

"We demonstrated that this method is potentially quite valuable as well as noninvasive, feasible and safe," said study director Irving Waxman, professor of medicine and surgery and director of the Centre for Endoscopic Research and Therapeutics at the university. "We had no complications related to portal vein blood acquisition," said Waxman.

Only 7% of patients diagnosed with stage II disease are still alive five years after diagnosis, making it one of the most lethal forms of cancer, the researchers said. The portal vein samples contained far more tumour cells in all stages evaluated, including locally advanced as well as metastatic tumours, the researchers said.

Blood collected from the portal vein had a mean of more than 100 CTCs per 7.5 millilitres. Patients with less advanced disease, who could potentially benefit from surgery to remove the tumour, had fewer CTCs. Those patients averaged about 80 CTCs per 7.5 millilitres. In contrast, when the researchers used peripheral blood to test the same patients, they found few, if any, circulating tumour cells.

Those samples contained less than one CTC in 7.5 millilitres of blood, the equivalent of one cell in a billion. The study was published in the journal Gastroenterology.

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Tuesday, 15 December 2015

Natco, Hetero Generic Pharma makers Get DCGI Nod to Sell Hepatitis-C (HCV) Drug

Thursday, 10 December 2015

Hetero’s ‘First Indian Company’ to Receive DCGI Nod to Treat Hepatitis C

Thursday, 3 December 2015

GPAT-2016 Tips and Tricks

Monday, 30 November 2015

Super veggies: Potatoes, onions keep stomach cancer at bay

Researchers develop new sensor that can detect estrogen levels in body fluids

Government launches injectable vaccine to prevent polio re-emergence

Sunday, 29 November 2015

New test may improve diagnosis of pancreatic cancers

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