analytica Anacon India and India Lab Expo returns to Hyderabad from Oct 20 to 22

analytica Anacon India and India Lab Expo 2016, the annual trade fairs for analysis, laboratory and biotechnology will be returning to Hyderabad from October 20 to 22, 2016. The event will be held at the Hitex Exhibition Center.

Accompanying the trade fair, the analytica Anacon India and India Lab Expo conference will be held from October 20 to 21. This year's conference focuses on analytical instrumentation, emerging trends in application, techniques and regulatory compliance.

'Regulatory aspects of Pharmaceutical Laboratories', 'Biopharmaceuticals and Bioanalysis', 'Food Safety' or 'Clinical Diagnosis' are the main topics of the 2016 edition of the analytica Anacon India and India Lab Expo conference. The speakers, eminent scientists and industry representatives, come from both – India and overseas. The programme is rounded out by tutorials in all four sessions where practical application tips are passed on the audience.

Among this year's speakers are Dr Laxmikant Gandikota (Biological Evans), Dr. Ashes Ganguly (Indian Analytical Instruments Association),  Prof. Dr. Myeong Hee Moon (Yonsei University),Prof. Dr. Michael Hilderbrand (University of Jena), Prof. Dr. Dietmar Knopp (Technical University of Munich), Prof. Dr. Rainer Lehmann (University of Tuebingen), Dr. Eike Reich (CAMAG), Dr. Pia Rosendahl (ISAS), Prof. Dr. Michael Rychlik (Technical University of Munich), Prof. Oliver Schmitz (University of Duisburg-Essen), Arjan Timmerman (Waters Corporation)and Dr. S. P. Vasireddi (Vimta Labs).

Natural compound from a deep-water marine sponge found to reduce pancreatic tumor size

Scientists at Florida Atlantic University's Harbor Branch Oceanographic Institute found that a deep-water marine sponge collected off of Fort Lauderdale's coast contains leiodermatolide, a natural product that has the ability to inhibit the growth of cancer cells as well as block cancer cells from dividing using extremely low concentrations of the compound. This work resulted in the award of a patent from the U.S. Patent and Trademark Office protecting the use of the compound against various forms of cancer. Sea sponges are an ancient group of animals that appeared more than 600 million years ago that have many of the same genes as humans. These scientists are taking advantage of this similarity in human and sponge genomes to isolate marine natural compounds from these organisms to develop medicines useful in the treatment of human diseases such as cancer. The researchers are expanding on their original findings, recently showing that leiodermatolide can reduce pancreatic tumor size in vivo, publishing the results of this study in the International Journal of Cancer (IJC).

Pancreatic cancer is the fourth leading cause of cancer death in the United States. Pancreatic cancer patients have less than a seven percent survival rate within five years of diagnosis, and 74 percent of patients die within the first year of diagnosis. In recent years, pancreatic cancer has received considerable attention because many well-known individuals have died from the disease. September marks seven years since the passing of actor Patrick Swayze, and October will be five years since the death of Apple Inc. co-founder Steve Jobs. The great tenor Luciano Pavarotti also died from this disease almost a decade ago.

Six leading scientists to receive prestigious Novartis Prizes for Immunology at 16th International Congress of Immunology

Today Novartis announced that six scientists will receive the 2016 Novartis Prizes for Immunology at the upcoming 16th International Congress of Immunology (ICI) in Melbourne, Australia on Aug 22, 2016. The Novartis Prizes for Immunology are awarded every three years for breakthrough contributions to the fields of basic and clinical immunology. Each of the two Prize categories is endowed for CHF 100,000 and can be shared by up to three scientists.

"This year's prize recipients are scientific pioneers who have delivered novel concepts and opened the door to uncharted fields at the forefront of immunological research," said Dhavalkumar D. Patel, M.D., Ph.D, Head of Research Europe and Global Head, Autoimmunity, Transplantation and Inflammation research at the Novartis Institutes for BioMedical Research. "We are proud to sponsor these prizes as part of our continued commitment to supporting innovative research in immunology."

The winners were selected by an independent jury of seven world-class immunologists for their groundbreaking research into the biology of the immune system. Each recipient has had a tremendous impact on the understanding of T-cell mediated mechanisms such as tolerance (basic immunology) and how these principles can be exploited to design therapeutic approaches (clinical immunology).

The Novartis Prize for Basic Immunology 2016 is shared by John Kappler (National Jewish Health, USA), Philippa Marrack (National Jewish Health, USA) and Harald von Boehmer (Emeritus, Harvard Medical School, USA) for their work in demonstrating how the immune system is able to discriminate "self" from "non-self" through a process in the thymus based on positive and negative selection via T-cell receptor mediated recognition of peptide-MHC complexes.

Why is breast cancer common but heart cancer rare?

Malignant cancers strike certain organs, such as the colon or breast, more often than others. In an Opinion publishing August 9 in Trends in Cancer, researchers propose that this vulnerability in some organs may be due to natural selection. Humans can tolerate tumors in large or paired organs more easily than in small, critical organs, such as the heart, and so the larger organs may have evolved fewer mechanisms to defend against cancerous cells.

"The organs that are the most important to keeping you alive and capable of reproduction, such as the heart, brain, or uterus, may enjoy a better protection against cancer, all other things being equal," says Frédéric Thomas, an evolutionary biologist at the Center for Ecological and Evolutionary Cancer Research in France. "We are not saying that this is the main factor to explain the different susceptibility of organs to cancer, but it is a factor that contributes with others."

Many oncologists have explained the difference in rates of organ cancer by looking at either external risk factors, such as smoking or UV light exposure, or internal factors, such as how often cells must divide in an organ. Thomas and his coauthors, including senior author Beata Ujvari, an evolutionary ecologist at Deakin University in Australia, now propose this evolutionary theory to supplement the current understanding.

The team suggests that natural selection has favored strong anti-cancer protection for small organs that are critical to human survival and reproduction. "Organs that are large or in pairs could potentially accumulate larger numbers of oncogenic manifestations without being impaired, whereas small and important organs like the pancreas could be easily compromised with only a few tumors inside," says Thomas. Therefore, so the theory goes, the pancreas should be better at defending against cancer compared to an organ like the kidney, if all other factors are equal. Anti-cancer protection mechanisms vary from organ to organ, but in general, they make an organ resistant to tumor formation.

Ethylene prices, markets & analysis

Ethylene price reports are covered weekly in Asia, Europe and US and also daily in Asia. Reports include analysis and market intelligence on contract and spot prices, margins, production issues, upstream and downstream news and any other influencing factor that is impacting price movements at that given time. In addition to weekly reports there are also margin reports for each region.

The vast array of information available on these markets can be received in a variety of formats and gives the subscriber confidence in making informed business decisions.

Gaumard introduces OMNI 2 touch-screen wireless interface

Gaumard Scientific Company announced the launch of OMNI 2, a touch-screen wireless interface that transforms training with value-priced simulators and skills trainers into an easy, intuitive tap-and-go experience.

OMNI 2 can be used on the fly for active mobile scenarios and provides full control over simulator physiology and response.

OMNI 2 will drive value-priced simulators and skills trainers to deliver additional functionality with features long associated with the company's high-fidelity simulators. Simulations and clinical scenarios will be included in one complete package.

For those with a limited budget and resources, OMNI 2 is an affordable, easy-to-use solution.

OMNI 2 controls obstetric and neonatal simulations and facilitates CPR training and monitoring for over 35 vitals, including HR, ECG, RR, BP, O2SAT and ETCO2.

Play, Pause and Reset features bring greater flexibility and control to obstetric simulations such as shoulder dystocia. And OMNI 2 features real-time monitoring of ventilation performance to improve neonatal resuscitation technique.

Berry wine, minus the alcohol, may offer help for those with diabetes

Blueberries, and berries in general, are among foods labeled as "diabetes superfoods" by the American Association of Diabetes. Food science researchers at the University of Illinois have found that fermenting berries may improve their antidiabetic potential even more.

Recent research at the U of I includes the development of an alcohol-free blueberry-blackberry "wine" that those suffering from diabetes - who typically must avoid alcohol - can enjoy, while potentially reducing the effects of Type 2 diabetes.

"Unfortunately the number of people with diabetes is increasing astronomically around the world," says Elvira de Mejia, a food chemist in the Department of Food Science and Human Nutrition at U of I. "There are 100 million people around the world who have diabetes and that is increasing, without counting the ones who may be pre-diabetic and not know it."

Previous research has shown that dietary blueberries may play a role in reducing hyperglycemia in obese mice, therefore de Mejia and colleagues wanted to determine if a fermented, dealcoholized blueberry-blackberry beverage would enhance the potential of the phenolic compounds in the berries that are responsible for reducing diabetic markers.

A new study shows that the fermented berry beverage did reduce the development of obesity and blood glucose levels in mice on a high-fat diet.

The researchers had already determined that the berries, when fermented at low temperatures, resulted in an improved and higher concentration of anthocyanins. Anthocyanins, found in the pigments of fruits such as blueberries, grapes, and apples, have been shown to promote insulin sensitivity, decrease blood glucose levels in the blood, and enhance insulin secretion.

"We know that fruits, vegetables, cereals, legumes, and berries are good, but here we explain that after fermentation we improve and increase the concentration of these pigments [anthocyanins] and they are very high antioxidant components that benefit the body," de Mejia says.

A previous cell culture study with the alcohol-free blueberry-blackberry wine, showed good results toward inhibiting enzymes related to glucose absorption.

"In this in vivo study, as we increased the concentration of these anthocyanin-enriched extractions from blueberries and blackberries we saw an improvement in the uptake of glucose, meaning that the animals with the increased concentration were not as much in a state of hyperglycemia as the other animals."

The beverage included a ratio of 70 percent fermented blackberries to 30 percent fermented blueberries. The berries were collected from varieties grown at U of I's Dixon Springs Agricultural Research Station in southern Illinois. Alcohol was removed from the beverage by rotoevaporation and was replaced with water. Some of the sugars left over after fermentation were also removed in the process.

"We optimized the best ratio between blueberries and blackberries. Blackberries are very unique and I think that's one of the reasons why we selected a high concentration of them in this study. Blackberries have a very specific profile of anthocyanins, and that was amazing at lowering the absorption of glucose in this case," de Mejia says.

During the study, groups of mice with diet-induced obesity and hyperglycemia were given the fermented berry beverage or the beverage with higher or lower enriched concentrations of the anthocyanins (0.1x, 1x, or 2x). Another group was given sitagliptin, a commonly used medication for diabetes, and another group was given water only. All groups ate the same diet, calories, and amount of sugars otherwise.

While benefits were seen in all groups drinking the fermented beverage, de Mejia says the group on the highest concentration of anthocyanins (2x) showed the greatest results, comparable to what was observed in the group on sitagliptin. This included no increase in body weight, which de Mejia says was a surprise.

Pfizer aims to become industry leader in gene therapy with acquisition of Bamboo Therapeutics, Inc.

Pfizer Inc. (NYSE:PFE) has acquired Bamboo Therapeutics, Inc., a privately held biotechnology company based in Chapel Hill, N.C., focused on developing gene therapies for the potential treatment of patients with certain rare diseases related to neuromuscular conditions and those affecting the central nervous system. This acquisition significantly expands Pfizer's expertise in gene therapy by providing Pfizer with a clinical and several pre-clinical assets that complement the company's rare disease portfolio, an advanced recombinant Adeno-Associated Virus (rAAV) vector design and production technology, and a fully functional Phase I/II gene therapy manufacturing facility that Bamboo acquired from the University of North Carolina earlier this year.

Gene therapy is an emerging area of medical research focused on highly specialized, one-time, transformative treatments addressing the root cause of diseases caused by genetic mutation. Gene therapy is a promising investigational technology, especially for patients with rare diseases, many of which are caused by a single genetic mutation. The technology involves introducing genetic material into the body to deliver a corrected copy of a gene to a patient's cells to compensate for a defective one. The genetic material can be delivered to the cells by a variety of means, most frequently using a viral vector such as rAAV. There have been no gene therapy products approved in the U.S. to date.

"The field of gene therapy research has made tremendous strides in recent years, and we are pleased to be able to further enhance our leadership position in this area through this transaction with Bamboo," said Mikael Dolsten, President, Pfizer Worldwide Research & Development. "We believe that gene therapy may hold the promise of bringing true disease modification for patients suffering from devastating diseases, and we hope to see this promise come to fruition - through new and existing in-house capabilities and potential partnership opportunities - in the years to come."

Bamboo's portfolio includes potential best-in-class rAAV-based gene therapies that will complement Pfizer's rare disease and gene therapy portfolios in two priority areas: neuromuscular, with a pre-clinical asset for Duchenne Muscular Dystrophy (DMD); and central nervous system, with pre-clinical assets for Friedreich's Ataxia and Canavan disease, and a Phase I asset for Giant Axonal Neuropathy.

Bamboo's approximately 11,000-square foot, fully staffed and operational manufacturing facility has experience producing Phase I/II materials using a superior suspension, cell-based production platform that increases scalability, efficiency and purity. This helps enable the DMD program and other projects requiring large amounts of rAAV. The facility, previously known as the University of North Carolina Vector Core facility, has served as a qualified supplier of rAAV vectors for several healthcare companies and academic institutions.

Bristol-Myers Squibb reports second quarter financial results

Bristol-Myers Squibb Company (NYSE:BMY) today reported results for the second quarter of 2016, which were highlighted by strong sales, key regulatory and clinical milestones in Immuno-Oncology and business development transactions that strengthened the company's Immuno-Oncology pipeline.

"During the second quarter we delivered strong sales and earnings growth, achieved important regulatory milestones with Opdivo across multiple types of cancer, and further advanced our leadership in Immuno-Oncology through the breadth of the clinical data we presented at ASCO," said Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb. "I am confident strong performance of our in-line products, progress with our diversified pipeline and our focused approach to business development position us well for continued success."

Second quarter financial results

• Bristol-Myers Squibb posted second quarter 2016 revenues of $4.9 billion, an increase of 17% compared to the same period a year ago. Global revenues increased 18% adjusted for foreign exchange impact. Excluding Abilify and Erbitux , global revenues increased 24% or 26% adjusted for foreign exchange impact.
• U.S. revenues increased 46% to $2.7 billion in the quarter compared to the same period a year ago. International revenues decreased 6% primarily from lower Hepatitis C Franchise sales in Japan and France. When adjusted for foreign exchange impact, international revenues decreased 4%.
• Gross margin as a percentage of revenues was 75.2% in the quarter compared to 75.7% in the same period a year ago.
• Marketing, selling and administrative expenses increased 9% to $1.2 billion in the quarter.
• Research and development expenses decreased 32% to $1.3 billion in the quarter. Research and development expenses in the second quarter of 2015 include an $800 million charge resulting from the Flexus acquisition.
• The effective tax rate was 26.4% in the quarter, compared to 311.5% in the second quarter last year. The second quarter 2015 Flexus acquisition was non-deductible for tax purposes.
• The company reported net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.69 per share, in the quarter compared to a net loss of $130 million, or $0.08 per share, a year ago. The results in the second quarter of 2015 include a $0.48 per share charge from the Flexus acquisition.
• The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.69 per share, in the second quarter, compared to $890 million, or $0.53 per share, for the same period in 2015. An overview of specified items is discussed under the "Use of Non-GAAP Financial Information" section.
• Cash, cash equivalents and marketable securities were $7.9 billion, with a net cash position of $1.2 billion, as of June 30, 2016.

Losing weight lowered levels of proteins associated with tumor growth

Overweight or obese women who lost weight through diet or a combination of diet and exercise also significantly lowered levels of proteins in the blood that help certain tumors grow, according to a Fred Hutchinson Cancer Research Center study published July 14 in Cancer Research, a journal of the American Association for Cancer Research.

Two study leaders - Dr. Catherine Duggan, principal staff scientist in the Public Health Sciences Division, and Dr. Anne McTiernan, cancer prevention researcher in the Public Health Sciences Division and the article's senior author - are available to provide details on the study and its implications.

The study:

• Measured three proteins that are known to enhance tumor-related angiogenesis - the formation of blood vessels that feed tumors and enable them to grow.
• Was intended to see how cancer-promoting proteins changed when overweight, sedentary, postmenopausal women lost weight through diet or diet and exercise over the course of a year.
• Enrolled 439 healthy women (they did not have cancer), placing each participant in one of four study arms:
  • Calorie- and fat-restricted diet.
  • Aerobic exercise five days a week.
  • Combined diet and exercise.
  • Control (no intervention).
• Found that women in the diet arm and the diet and exercise arm lost more weight and had significantly lower levels of angiogenesis-related proteins, compared with women in the exercise-only arm and the control arm.

The authors said that it is known that being overweight and having a sedentary lifestyle are associated with increased risk for developing certain cancers, but the reasons for this relationship are not clear.

Over 750 biomarkers identified as potentials for early cancer screening test

Researchers have identified 788 biomarkers in blood that could be used to develop an early stage cancer screening test for the general population. The study, led by the University of Sheffield, is the first to create a comprehensive list of relevant cancer blood biomarkers that have been researched in the last five years. The study also groups them by molecular function and records the technologies that can be used to detect them.

The team - from the Universities of Sheffield, Coventry and Warwick - started with over 19,000 scientific studies published over the last five years that investigated blood based biomarkers. Systematic review methods - including ruling out studies in fewer than 50 patients - reduced this to 4,000 studies from which the final biomarker list was compiled.

Lead researcher, Dr Lesley Uttley, from the University of Sheffield's School of Health and Related Research, said: "Because of the sheer number of publications in this field, previous reviews have only been able to look at one biomarker or a small group of biomarkers. Our data mining approach allowed us to take in all relevant research findings from the five-year period, which meant we could map the full range of potential blood-based biomarkers that are particularly relevant for early detection of cancer."

The work was carried out on behalf of the Early Cancer Detection Consortium, a group of nearly 40 organisations, including universities, hospitals and commercial companies. The Consortium was funded by Cancer Research UK to investigate whether a cost-effective screening test can be used in the general population to identify people with early stage cancers.

The next step will be to look in detail at the research behind each biomarker, to check that it is robust and that the biomarker could feasibly be used as part of a screening test. Biomarkers will also be grouped by cancer type at this stage. The validated biomarkers will then be put through a clinical study, using samples from cancer patients and healthy controls, to check how effectively they identify the presence of cancer.

Finally, those biomarkers which work successfully in the study will be taken forward into a clinical trial, to see if the screening test works in practice and is cost-effective.

ECDC Director and Molecular Pathologist at University Hospitals Coventry and Warwickshire NHS Trust, Professor Ian Cree, said: "Our expectation is that, once the validation and clinical studies are completed, we will have a suite of around 50 biomarkers, identified using four different tests, that can go into the clinical trial. To complete the validation and the trials will take six to eight years, but in theory, we could have a test ready within three years for use in high risk groups".

SwastiChmex - Product list

Expertise in manufacturing of API Intermediates

                 Intermediate name                        CAS NO’S                    API name

1.       4-BromoPhenyl acetic acid                                CASNO: [1878-65-5]                Bilastin

2.       4-Bromo benzyl cyanide                                     CASNO: [16532-79-9]             Bromo phenaramine  Maleate

3.        4-Methoxy-3-sulfamoylPhenyl acetone         CASNO:[116091-63-5]            Tamsulosin

4.       1-(2-Bromoethoxy)-2-methoxybenzene         CASNO: [4463-59-6]                Tamsulosin

5.       Cyclopropyl isonitrile                                          CASNO: [58644-53-4]             Telaprevir                

6.        3,5-Bis-(Di bromo methyl ) toluene                CASNO:[19294-04-3]               Anastrazole                    

7.        6-Nitro Veratric acid                                          CASNO: [4998-07-6]                Doxazocin

8.        4-Nitro Pyridine N-Oxide                                  CAS NO:[1124-33-0] 

9.       3,5 Dimethyl -4-Nitro Pyridine-N-Oxide          CAS NO:[14248-66-9]             Omeprazole

10.   2, 3- Dimethyl-4- Nitro Pyridine- N-Oxide  CAS NO:[37699-43-7 ]            Lansaprazole

Reagents Class

11.   Tertiary butyl nitrite (> 80% )                            CASNO:[540-80-7 ]

12.   Iso amyl nitrite           (>80% )                            CASNO: [110-46-3 ]

13.   Morpholine Hydrochloride                                CASNO: [10024-89-2]

Fine Chemicals

14.   4-Nitro-3-Picoline-N-oxide                                      CASNO:[1074-98-2 ]

15.   2-Picoline-N-Oxide                                                   CASNO: [931-19-1]

16.   2-Chloropyridine-N-Oxide                                       CASNO:[2402-95-1 ]

17.   5-Nitro Barbuturic acid                                            CASNO: [480-68-2  ]

18.   2,4,6-TrichloroPyrimidine                                       CASNO: [3764-01-0]

19.   4-Bromo Guaiacol                                                    CASNO: [7368-78-7]

Contact : swasti.chemx@gmail.com 

Cyclopropyl isonitrile

Synonyms: Cyclopropylisocyanide;Cyclopropyl isonitrile;Isocyanocyclopropane;

• Name: Cyclopropane, isocyano-
• Molecular Formula: C₄H₅N
• Molecular Structure:
• Usage:
• Analytical:
• Analytical:
• CAS: 58644-53-4
• Chemical Properties:
• Molecular Weight: 68.10
• InChI: InChI=1/C4H5N/c1-5-4-2-3-4/h4H,2-3H2
• Specification: The cas register number of Cyclopropyl isocyanide is 58644-53-4. It also can be called as Cyclopropane, isocyano- and the Systematic name about this chemical is cyclopropyl isocyanide.
  Physical properties about Cyclopropyl isocyanide are: (1)#H bond acceptors: 1; (2)#H bond donors: 0; (3)#Freely Rotating Bonds: 0; (4)Polar Surface Area: 4.36Ų.
  
  More Details : Contact  :swasti.chemex@gmail.com
  
  

Oncurious begins phase I/IIa study with TB-403 to treat medulloblastoma

Oncurious NV, an emerging oncology company focused on the development of innovative orphan drugs for the treatment of pediatric cancers, has initiated a phase I/IIa study that will evaluate the safety and tolerability and explore the preliminary efficacy of TB-403 for the treatment of relapsed or refractory medulloblastoma, a rare, life-threatening brain tumor that mainly affects children.

Today's study initiation follows the earlier announced partnership between Oncurious, its TB-403 project partner BioInvent, and the Neuroblastoma and Medulloblastoma Translational Research Consortium (NMTRC) in the US. NMTRC is a collaboration of 25 US academic medical centers, teaching hospitals and other entities, with the purpose of facilitating and conducting collaborative research activities and investigations of new treatments for neuroblastoma, medulloblastoma and other pediatric cancers.

Headquartered at the Helen DeVos Children's Hospital in Grand Rapids, MI, USA, NMTRC is the key clinical trial partner for this Phase I/IIa study. The study aims at recruiting a minimum of 27 patients, with first results expected to be reported in 2017.

TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF) which is expressed in several types of cancer, including medulloblastoma. A paper in Cell in February 2013 (Cell, 152, 1065-76, 2013), highlighted for the first time that PlGF plays a role in the growth of medulloblastoma. The paper was based on pre-clinical research conducted by Prof Rakesh Jain from the Massachusetts General Hospital at Harvard (Boston) and the team of Prof Peter Carmeliet from the VIB/ KU Leuven.

MAKING PMS MANDATORY

The Union health ministry is considering to make it mandatory for the pharmceutical companies to have a Pharmacovigilance system within their organisation for the post marketing surveillance of new drugs launched in the market. The Drug Testing Advisory Board (DTAB) is working on a draft rule for the same so as to put in place a system of collecting, processing and forwarding the Adverse Drug Reactions report to the licensing authority by the companies. Pharmacy Council of India and Indian Council of Medical Research had suggested setting up of a pharmacovigilance department within each pharma company some time back as  most of them do not have such a system. The objective of the ministry is to make pharmacovigilance reporting mandatory on pharma companies in a bid to have detailed ADR data from the industry. In fact, the health ministry directed all the pharmaceutical companies last year to follow the practice of submission of Periodic Safety Update Reports (PSURs) of drugs on a regular basis but there has been no response from the industry so far.

In the absence of any cooperation from industry to generate detailed and reliable post marketing data of new drugs marketed in the country, the government itself took the initiative and established Pharmaco-vigilance Programme of India in 2010. The mission of PvPI is to safeguard the health of Indian population by ensuring that the benefit of use of medicine outweighs the risks associated with its use. ADRs are reported from different centres of the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute to the global ADRs data base. Drugs and pharmaceuticals are produced by pharmaceutical industry and approval for marketing the same is granted by the national regulatory authorities after duly verifying their efficacy and safety profile.  But even after three phase clinical trials, all approved medicines are not always found to be totally safe as trials are usually limited to a few thousands of patients. The need to have periodic safety assessment of any drug cannot be underestimated considering the fact that many drugs are getting withdrawn from the market even after their successful launches and remaining in the market for years. Apart from the safety of individual drugs, ADRs of thousands of combination drugs marketed especially in India are not all ascertained. This is a serious health issue neglected for so many years in India. It will be very difficult for the government's  pharmacovigilance machinery to collect such huge data of ADRs of all individual drugs and combinations from the market. Therefore, fixing that responsibility of collecting ADR data of drugs on the companies themselves is possibly the best option.

Care hospital performs first successful ‘Switch Liver’ transplant in Hyderabad

CARE hospitals, Hyderabad has successfully performed an unusual 'Switch Liver' transplant for the first time in India. This is the first such rare operation after the hospital opened its state-of-the-art liver surgery unit last year.

This landmark operation in Hyderabad suggests that we are now ready to do very complex liver surgery here within our city itself. Moreover this case proves that transplantation can be performed in these very sick patients with good results. Finally it shows that with good medical planning, even cases previously thought to be non-transplantable can be operated successfully, said prof. Tom Cherian, head of liver transplant surgery at CARE hospitals.

While explaining about the critical aspects of the surgery the professor explained that as the majority of the blood flow into the liver comes from the portal vein, a complete block of the portal and mesenteric vein inflow (called porto-mesenteric vein thrombosis) normally does not allow liver transplantation surgery.

However after careful examination and a high resolution CT Scan, the professor felt that the young age of the recipient plus his slender built would allow for completion of the surgery and respiratory wean. Finally the surgery was performed when a cadaveric organ became available. However at dissection a complete porto-mesenteric thrombosis was found despite recent imaging. Hence after discussion with experts from around the world Prof Cherian decided to perform a cavalswitch operation where instead of the portal vein, the cava was used to bring blood into the new liver. As this modification needed to be completed before the vulnerable liver graft died from prolonged lack of oxygen, there was additional stress on the team. The surgery lasted 13.5 hours and went well despite the blocked vessel, and the new liver started to work.

Zecotek receives patent for new advanced formulation of LFS scintillation crystals

Zecotek Photonics Inc., a developer of leading-edge photonics technologies for industrial, healthcare and scientific markets, has announced that its wholly owned division, Zecotek Imaging Systems Pte. Ltd., has been granted its first patent in a series of pending patents for its advanced formulation of its patented LFS scintillation crystals. The patent is for multi-doped lutetium oxide based scintillators having improved photonic properties.

“This patent protects our latest version of LFS scintillation crystals which are the fastest, brightest and most advanced scintillation crystals available to any OEM worldwide: the LFS-M,” said Dr. A.F. Zerrouk, chairman, president, and CEO of Zecotek Photonics Inc. “Most crystals for high resolution positron emission tomography (PET) imaging are based on stoichiometric formulations of lutetium oxide with silicate. While we also use lutetium oxide with silicate, our team of Russian scientists use an off-stoichiometric process which produces superior scintillators. No other company can produce crystal like ours, and no other crystal can compete with the LFS-M’s speed and brightness. We have filed similar patent applications in important jurisdictions around the world to re-enforce and strengthen the existing patent for our line of LFS scintillation crystals.”

The new patent protects Zecotek’s latest and most advanced formulations of “off-stoichiometric” multi-doped lutetium oxide based scintillation silicate crystals (LFS-M). Stoichiometric formulations are known to have matching number of reactants which produce full conversion of reactive groups into highly definable cross-linked products. However, intentional deviation from stoichiometric formulations, off-stoichiometric, enable the creation of products containing predictable amounts of other residual reactive groups which in turn enables the tuning of mechanical properties. By going off-stoichiometric, Zecotek’s scientific team has produced the fastest, brightest and most advanced LFS formulation available today.

Novartis ' PARADIGM-HF study shows Entrest reduces cardiovascular death/hospitalization for heart failure patients with reduced ejection fraction

Novartis announced new analyses of the data from PARADIGM-HF showing that Entresto (sacubitril/valsartan) consistently demonstrated benefit among heart failure patients with reduced ejection fraction (HFrEF), even when patients are considered clinically stable and regardless of background therapy.

An analysis of PARADIGM-HF patients found the following:

Even patients considered clinically stable - defined as patients with no history or a remote history of prior heart failure hospitalization - were still at risk for a serious clinical event.

In the analysis, over one third of patients were identified as clinically stable, and 20 per cent of those experienced a primary endpoint event (CV death or heart failure hospitalization). Among these patients, 51 per cent suffered CV death as their first event.

Further, the analysis determined that Entresto benefited patients considered clinically stable just as much as it did those who were least-stable (heart failure hospitalization within 3 months of baseline).

Among both groups, patients taking Entresto had a 20 per cent or greater reduction in CV death or heart failure hospitalization compared to those taking enalapril.

GSK receives Japanese marketing approval for Nucala to treat asthma

GlaxoSmithKline plc (GSK) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Nucala (mepolizumab) as a treatment for bronchial asthma in patients with refractory asthma whose symptoms are inadequately controlled with standard treatment. Nucala is licensed in Japan for adults and adolescents aged 12 years or older.

Nucala is the first medicine in a new class of anti-interleukin-5 (IL-5) biologic therapies. IL-5 plays an important role in regulating the function of eosinophils, inflammatory white blood cells known to be important in asthma. The medicine is administered as a 100 mg fixed dose subcutaneous injection once every four weeks. Patients will receive the treatment in addition to their existing respiratory medication, which comprises high-dose inhaled corticosteroids plus additional medicines, and may include maintenance oral corticosteroids.

Approval in Japan comes just four months after the approval of Nucala in the US – the first approval of an anti-IL-5 treatment anywhere in the world.

Philippe Fauchet, president, GSK Japan said: "As the market leader in respiratory medicine, GSK has been focused on gaining approval and launching its new respiratory medicines to meet the needs of patients in Japan. Approval of Nucala not only complements our respiratory portfolio but also gives us the opportunity to make a difference to the lives of more patients in Japan. It is our aim to make Nucala available in Japan as soon as possible to support the needs of a significant group of severe asthma patients whose condition is driven by eosinophilic inflammation, which is difficult to control."

The MHLW assessment of mepolizumab was based on data from the global clinical development programme, including the pivotal DREAM (MEA112997), MENSA (MEA115588) and SIRIUS (MEA115575) studies, which investigated the efficacy and safety of mepolizumab in patients with severe eosinophilic asthma. All patients in the phase III MENSA and SIRIUS studies had peripheral blood eosinophil levels greater than or equal to 150 cells/µL at initiation of treatment or greater than or equal to 300 cells/µL within the past 12 months.

Nucala is a monoclonal antibody that stops IL-5 from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood, tissue and sputum eosinophil levels.

Mylan introduces Tramadol HCl extended-release tablets in US market

Mylan N.V.,a global pharmaceutical company, announced the US launch of Tramadol hydrochloride extended-release tablets USP, 100 mg, 200 mg and 300 mg, which is the generic version of Valeant's Ultram extended-release tablets.

Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

Tramadol hydrochloride extended-release tablets USP, 100 mg, 200 mg and 300 mg, had US sales of approximately $52.8 million for the 12 months ending December 31, 2015, according to IMS Health.

Currently, Mylan has 265 ANDAs pending FDA approval representing $110.3 billion in annual brand sales, according to IMS Health. Forty-eight of these pending ANDAs are potential first-to-file opportunities, representing $38.3 billion in annual brand sales, for the 12 months ending Dec. 31, 2015, according to IMS Health.

[tags Mylan,pharmaceutical,,regulatory,ANDAs, ]