Atrial fibrillation screening to help reduce stroke risk

Recently, researchers from the University of Sydney, the study showed that for individuals aged 65 and over were asymptomatic atrial fibrillation screening and the use of anticoagulant drug therapy may be able to greatly reduce the individual deaths due to stroke and premature death risks related to research published in the international journal Journal of the American Medical Association on.
Atrial fibrillation (AF) is an abnormal heart rhythm, it will give patients the risk of heart thrombosis, when blood clots break will flow into the brain cause serious stroke. Previous studies have found that compared to age and sex-matched individuals without atrial fibrillation, the risk of stroke in asymptomatic individuals with atrial fibrillation and premature death is two times the former. A lot of evidence that the use of oral anticoagulation with warfarin or novel oral anticoagulant to treat symptoms of atrial fibrillation or completely reverse the individual stroke risk, but also can partially reverse the individual risk of premature death.
The researchers, Professor Ben Freedman noted that comprehensive screening of asymptomatic patients with atrial fibrillation can help reduce the risk of an individual stroke-related disability and also can save the lives of patients; however, the current screening program is not in the guidelines recommend. Atrial fibrillation is a common heart arrhythmia serious performance problems in every three patients had a stroke patient, and in 27% of patients with atrial fibrillation-related stroke, a heart rhythm disorder often does not precede asymptomatic atrial fibrillation is detected; detecting atrial fibrillation usually random and heart palpitations or increased heart rate is not directly related, which may help explain why stroke occurs very surprised, but also a serious manifestation of atrial fibrillation.
Article, the researchers found that atrial fibrillation can thereby obtain test results through the use of new palm devices adsorbed on iPhone, the patient's electrocardiogram detected, may be within 30 seconds of detecting atrial fibrillation based iPhone ECG equipment; the use of such a simple methods to detect atrial fibrillation, you can use a special therapy to improve the poor prognosis, the researchers believe is reasonable and effective screening tool for detecting abnormal heart rhythms individual is very important for improving their health may also provide some help.

Predict cancer or not a dream! British scientists found that a typical gene mutation

British Sanger Institute, geneticist Michael Stratton published in "Nature Genetics" magazine reported that he and his colleagues studied the DNA sequence 10,000 cancer patients, trying to find representatives of genetic variation.

Stratton said that every cell in the human body contains DNA, DNA may mutate. Some variations are sudden, such as sunlight or caused by a large number of long-term smoking, but some variation of slow and steady, it bit by bit over time, damage DNA, and ultimately lead to cancer.

Stratton and colleagues found two typical variation - Under normal circumstances, the greater the age, the more these two gene mutation. If the speed of a person's two variations faster than the average person that he is suffering from a higher risk of cancer.

Stratton said the findings may help doctors "predict" cancer, but also can help the medical team for the patient tailored treatment. Perhaps one day, scientists can also slow down the variation of "pace" to help people keep alive Young.

(Bolise Co., Ltd. www.chemicalspharm.com)

Johnson anti-tumor drug Yondelis heavy granted after a lapse of six years

Drug development is a long process, from pre-clinical to clinical research will experience a considerable period of time. However, faced with strict examination and approval of the relevant medical management department, drug development cycle will be longer even in the foreseeable future. Faced with this situation, many pharmaceutical companies adhere to teeth only select this approval marathon.
Johnson & Johnson recently announced the development of anti-cancer drug Yondelis has been approved by the US FDA for the treatment of soft tissue sarcoma. This marks Yondelis three occasions, approval was finally ended the marathon continued for six years. FDA said that the future Yondelis will be approved for the treatment can not be removed by surgery and chemotherapy liposarcoma and leiomyosarcoma patient tolerance type.
This approval is based on the latest phase III clinical study results submitted by Johnson & Johnson. In this there are 518 patients involved in the study, compared to conventional chemotherapy dacarbazine, Yondelis can significantly prolong the survival of patients.
For Johnson & Johnson, the approval of Yondelis is undoubtedly the end of a painful journey.
In 2001, Johnson & Johnson is obtained from the Spanish pharmaceutical company Zeltia authorization of this drug, and began Yondelis in ovarian cancer. In 2009, FDA because of security problems and the effect is not too significant and other reasons rejected the listing application Yondelis and Doxil combination therapy. Two years later the same reason, Johnson was forced to suspend the project and turn malignant sarcoma research and development.
Earlier, at Zeltia companies and other partners efforts, Yondelis has been successfully listed on the world's countries and regions. And after a lapse of six years, Yondelis is approved in the US market is undoubtedly an important supplement to the drug market. After a marathon six years, holding exclusive rights to sell Yondelis US market will probably sigh of Johnson & Johnson.
Johnson & Johnson said that soft tissue sarcoma is a rare malignant tumor, about five thousand people die each year of diseases. The two approved indications Yondelis is a higher degree of malignancy of this tumor type.

FDA for a treatment of advanced non-small cell lung cancer (NSCLC) in patients with oral drug granted accelerated approval

US FDA for a treatment of advanced non-small cell lung cancer (NSCLC) in patients with oral drug granted accelerated approval. Tagrisso (osimertinib) is now approved for use in tumor specific epidermal growth factor receptor (EGFR) mutation (T790M), and patients with other EGFR inhibitor treatment after disease progression.
Lung cancer is the major cause of death in the United States, according to information provided by the National Cancer Institute, in 2015 an estimated 221,200 new cases diagnosed, there are 15.804 million people will die from the disease. Non-small cell lung cancer is the most common form of lung cancer, when the cancer cells in the lung tissue formation occurs non-small cell lung cancer. EGFR gene is a participation in the growth and spread of cancer cells a protein.
"We are the molecular basis of lung cancer and these cancers become resistant to previous treatments cause of rapid progress in understanding the positive," oncology office, Dr. FDA Center for Drug Evaluation and Research, said blood and medical Pazdur. "The ratification of resistance mutations in patients with EGFR-positive (T790M) testing was to provide a new therapeutic drugs, the approval of substantial evidence-based clinical trials, these clinical trials have shown that more than half of Tagrisso in patients with prior treatment shrink tumors have a significant effect. "
Today, FDA also approved to detect targets -EGFR Tagrisso known resistance mutations associated with the first type of diagnostic tests (cobaseGFR Mutation Test v2). Version (v2) for the initial detection of the latest approved CobaseGFR Mutation Test (v1) detection of clinically relevant mutations increase the T790M mutation.
"In the cancer field, along with a safe and effective diagnostic testing and drug approval is still important progress" in vitro diagnostic devices and radiological health centers FDA and Radiation Health Office, Ph.D., Gutierrez said. "CobaseGFR Mutation Test v2 availability to meet this significant demand for EGFR gene mutations, which can change the therapeutic effect."
safety and effectiveness agrisso in two multi-center, single-group study was confirmed, the subject of these two studies after 411 in an EGFR-blocking drugs treat disease progression EGFR T790M mutation positive advanced non-small cell lung cancer patients. These two studies, the first study 57% of patients and 61% of study patients experienced a second tumor completely or partially reduce shrink (objective response rate). Further validation studies continue approved for this indication may be based.
Tagrisso most common side effects are diarrhea, skin and nail disorders (such as dry skin), infections or rashes and redness around the nail. Tagrisso may cause serious side effects including lung inflammation and heart damage. The drugs also may cause harm the developing fetus.
FDA grants AstraZeneca Tagrisso breakthrough drugs qualifications, priority review and orphan drug eligibility qualifications. Awarding breakthrough drugs that are designed to treat serious diseases, drugs listed in the application materials submitted, preliminary clinical evidence that the drug with existing therapies may prove a substantial change compared to.
Granted priority review of eligibility to apply for those drugs for the treatment of serious diseases in safety or efficacy show a significant improvement. Orphan status can provide incentives, such as tax credits, fee waivers and the applicant qualifications market exclusivity, thereby helping and encouraging the development of drugs for rare diseases.
Tagrisso in FDA approved under accelerated approval program, based on accelerated approval to allow the display of a drug on a reasonable proxy may be used to predict clinical benefit endpoint effective clinical data to approve a serious or life-threatening disease that drug treatment. This program allows patients earlier access to promising new drugs, but the drug applicants while confirmatory clinical trials to be carried out.
Tagrisso by the Wilmington, Delaware AstraZeneca marketed. CobaseGFR Mutation Test v2 by the California Roche Molecular Systems in Pleasanton sale.

Clinical trials for fraud penalties too light

Clinical trial data recently, China Food and Drug Administration announced that eight pharmaceutical companies 11 drug applications for registration untrue, incomplete, decided not to approve its application for registration, five institutions involved in clinical trials are the top three public hospitals, to initiate an investigation.
You should see, the State Food and Drug Administration on July 22 this year, released the so-called "history of the most stringent data verification requirements of" Notice (No. 117 text), requiring pharmaceutical companies to self-examination, otherwise the discovery data fraud will be severely dealt with in its verification, . After more than a month, self-examination results were out, the original number received in 1622, pharmaceutical companies guilty withdraw 20% of the registration application. 11 test data found fake drugs now, you should belong to their own situation did not withdraw the application and approval procedures are found in the.
Clinical trials of drugs, is a prerequisite for the approval of new drugs, millions of people related to drug safety, but also a sacred cause. Now he was exposed pharmaceutical companies and clinical trials hospital collusion, a large area of ​​the phenomenon of false test data, in particular should have "life-saving for the bounden duty," the top three public hospitals, will also participate in fraud, which is the "intentional homicide" Yi? If you miss the patients' lives, "who bear its responsibility? No wonder netizens feel both "before the fear of" also "scared." "Before the fear" that in the end how many such substandard drugs has flowed into society, many people's physical and mental harm and life; "scared" is relevant to investigate the breadth, depth and intensity, can be completely into the community The channel cut off it?
Clinical trial data fraud so serious, is not suddenly emerge as a new disease. State Food and Drug Administration who had admitted that "drug approval clinical data fraud is already an open secret in the industry, not an isolated phenomenon, but rather a common phenomenon," period "from 2007 to 2008, and then every two or three years, the State Food Drug Administration have focused on consolidation, but so far, the chaos has not been effectively curbed, "a serious problem to the extent evident.
Investigate clinical trials data fraud, not without national legal basis. "Drug Administration Law" stipulates that drug manufacturers, drug clinical trial institution is not in accordance with the implementation of Good Clinical Practice (GCP), and given a warning and ordered to make corrections; overdue correction shall be ordered to stop production, suspend business for rectification, and impose a five thousand yuan to 20,000 yuan fine; circumstances are serious, revoked "drug production license" and drug clinical trial institution qualification.
The competent authorities in accordance with the argument, long-standing problem, logically there should be some units that investigate announcements and warnings, but in public information due to clinical trial data fraud investigation by pharmaceutical companies, almost one case related to hospitals are not retrieved. The Food and Drug Administration hospital system than someone direct filing, indeed quite obviously determined: Only when this "thorough investigation to punish" has become the norm, the probability of illegal promotion by the investigation, which had itself the only hazard fraud You will be curbed.
From this investigation pharmaceutical companies and public hospitals, the administrations ability to identify problems, no doubt. But now, the relevant sanctions does not match the extent of its bad behavior: pharmaceutical companies currently involved in clinical trials for fraud data, clinical trials institutions, contract research organizations and their direct responsibility, the punishment is blacklisted, and to Social publish relevant organization code, identity card numbers and other personnel, suspected of a crime, the transfer of public security organs investigation.
But taking into account this "blacklist" just inside outward publish some of the "code" and "number" are not really even punishment (is not punishment species), which from the public expected "punish" Obviously there is distance. 117 paper, "the most stringent standards, the most stringent regulation, the most severe punishment, the most serious accountability", the legal aspects of the "bell" is the basic premise, which include administrative accountability. Even if the administrative responsibility could not see, so-called transfer of suspected criminal justice, is the feint.

Three typical cases of grade clinic floor and facing the four major problems

Internet graded clinics since the last written after the author and many medical practitioners chatted basic status classification diagnosis and treatment, it has also participated in many mobile medical forum. But it found that tiered treatment model are many, mobile medical players also gives different ideas, can talk mode only for grading clinics yourselves, really want to achieve grade treatment depends on how the floor, and even said Can landing.
Of course, we first look at the current concern of the four grading treatment model, it has a kind of common ground and differences between them.
First, from being talked about a lot of national experts "American model" is concerned. Obama's health reform plan several times to become the world's focus of attention, even if the health care system is highly developed United States still faces a number of medical problems. American health care system was graded clinics rely on the family doctor system, a preliminary diagnosis and treatment by a family doctor, and then sent to the appropriate patient to the hospital, and then by a nurse or doctor for further emergency triage according to critical indices. In other words, the patient will first find a family doctor, a family doctor can not solve the disease re-triage to hospital for treatment specialist, to a large extent eased the pressure on hospital visits.
The next thing to say is "British model", the British medical system of classification as a practice of the earliest and most stringent Western countries, medical grade British welfare system has become typical. British health system implemented a strict hierarchical system, broadly speaking there are three, one community general practice, the second is a comprehensive general hospital, and finally to the emergency and major incurable diseases as the main business of teaching hospitals. High-end private physician services focused on micro number kgn091 medical industry. Apparently, the British medical grade in the system to have a great advantage, it can be said grading clinic just a derivative large health care system, in addition to grading treatment, including medicine and separate, square sale of drugs and doctor appointments. The World Health Organization was called the Chinese and the British medical classification of the "troika", its importance is evident.
However, given the complexity of the medical system and the public's habit medical point of view, I am afraid that the Anglo-American system of classification treatment are difficult to replicate at home. At present, 16 provinces and cities are exploring the feasibility of hierarchical diagnosis and treatment, but also the gradual improvement of the institutional mechanisms of hierarchical diagnosis and treatment.
Finally the Internet hierarchical treatment. In Internet + background, rely on the Internet for health care system reform has become a trend, for grading clinic, many mobile medical enterprise programs generally have the following. First Micro Medical Group "micro health model", its essence is through the Internet to achieve grade domestic treatment programs have been developed for collaboration between doctors via the Internet, according to the disease to match the corresponding medical team is triage, and using the Internet to establish a medical file. Second, Baidu, etc. are doing online interrogation mode, providing intelligent triage services through big data analysis, and according to the characteristics of clinical experts, patients push match. Third, mobile medical resources entrepreneurs pointed at doctors, trying to use the Internet to achieve the "free exercise medicine" to establish a health care system outside the reality of Internet health care system, and to explore a series of hierarchical diagnosis and treatment.
As can be seen, grading clinic system in Europe and America and other developed countries to provide a corresponding template, the country will also formally shouted slogans tiered treatment. However, as previously said, while the country has 16 provinces and cities in the exploration grading clinic, has how kind of status quo, and the Internet and has a kind of opportunity. We would also like to begin with the three typical landing cases.

1, primary care doctors how to improve the professional capacity?
Shanghai by general practitioners in more than a decade of training courses for nearly 4,000 general practitioners, while in other areas outside of Shanghai, the situation is even worse, especially in the west, many primary care doctors or troops came from Dr. Yu Chijiao medical positive soldiers. Currently, the mobile medical solutions, there are three, one settled in to provide some training opportunities for doctors, and thus attract more doctors to enter, from a practical standpoint, a gimmick than substance. The second is to promote cooperation and exchanges between doctors and other health through micro APP, on the one hand to improve internal communication and learning mechanism of the medical team, such as micro doctors each medical team set up a team of assistants is; on the one hand to strengthen the collaboration between different medical teams , especially in the triage medical team will conduct disorders and accurate matching. Third, telemedicine, that is, from mobile health APP doctor for help to get more opportunities, and to improve the ability of primary care doctors in triage. Many mobile medical companies keen on this, also proved to be an effective way. For mobile health, the doctors will be key to future resources knockout.
2, the Internet how to develop triage standards?
Even on the Internet go furthest medical grade micro Pharmaceutical Group, the triage criteria still rely Dr. Yu Shouzhen of experience, and then make the appropriate match. Although micro Medical Group Online triage team assistant has been a 8500 people, also in the accurate triage successes, we are still facing a shortage of triage standard short board. Mature rating in foreign medical system in Australia to develop a triage scale ATS, Canada has seized hurt urgent Scale CTAS, the United States also have emergency critical index ESI. Although the country will also have the appropriate emergency triage criteria, it does not seem to apply to the Internet graded clinics, whether doctors or other mobile medical micro enterprises, the importance of early formation of a more standardized triage criteria, rather than rely solely on experience.
3, how to improve the confidence of patients and primary care physicians?
Many people chose as the preferred tertiary hospital to see a doctor, the fundamental reason is distrust of primary care doctors, especially in the case of the high rate of misdiagnosis of primary care doctors, in addition to improving medical standards of primary care doctors, and using the Internet to reduce the misdiagnosis rate, and improve the doctor-patient trust without delay. Mobile medical doctors practice is to implement the responsibility system, similar to the pattern in Minhang signing community physicians. Indeed, there is provided a mobile medical team of medical experts APP is the responsibility of supporting and providing health care resources and referral consultation of the green channel, to a certain extent, in favor of the doctor's responsibility to implement. However, as soon as possible to move the medical health management and medical insurance is connected between the people and the responsibility of a team of doctors, doctor's responsibility to solve the income problem and mutual distrust.
4, how to improve the ability of community hospitals?
While some radical moves the company made to the hospital for medical technology, but micro medicine, Baidu, Ali and other mobile medical players and community hospitals knife Ge did not meet, but the community hospitals as an important part of the Internet hierarchical diagnosis and treatment, it faces question is how to improve the ability of community hospitals. Observation, there are two possible ways, first establish a remote diagnostic system to address community issues hospitals lack medical equipment, currently remote ECG has begun into the market, the mobile health care system is indispensable. Second, get the county medical resources, national classification county hospital clinic's goal is to be able to solve 90 percent of the disease, coupled with lower domestic higher hospital trusteeship reform, the strengthening of cooperation and the county hospital is not much ado about nothing.
Anyway, bottlenecks community hospitals and primary care physicians are graded clinics where, for all the mobile medical clinics to promote grading company and related sectors, the simple chat mode instead to work on primary care resources, medical grade floor but is paper Bale(Bolise Co., Ltd  www.acridine-raw-material.com)

Roche melanoma of new drugs approved by the FDA Cotellic

Swiss pharmaceutical giant Roche (Roche) cancer drug pipeline news came recently in the United States regulation, the company has developed an oral anti-cancer drugs targeting Cotellic (cobimetinib) to obtain FDA approval, Roche's own cancer drug marketed jointly Zelboraf (vemurafenib, Weiluofeini) for BRAF V600E mutation or V600K positive unresectable or metastatic melanoma patients. Cotellic also marks Roche receives FDA in the past five years, approved the first seven drugs. In the EU, Cotellic harvested in September this year, the European Medicines Agency (EMA) Committee for Medicinal Products for human use (CHMP) recommended approval of positive opinions, the EU is expected to get approval by the end of 2015. Before, Cotellic August this year was approved by Swissmedic. It should be noted, Cotellic and does not apply to patients with melanoma Zelboraf BRAF gene normal.
Cotellic approved, is based on Phase III data key coBRIM research, this study is an international, randomized, double-blind, placebo-controlled phase III study, in 495 cases previously untreated, BRAF V600 mutation carrying unresectable Locally advanced or metastatic melanoma patients conducted to investigate the Cotellic (60mg dose once daily) combined with Zelboraf (960mg doses, twice daily) efficacy and safety. Data show that, compared with Zelboraf + placebo group, deterioration Cotellic + Zelboraf combination therapy group of diseases or significantly reduce the risk of death, progression-free survival (median PFS: 12.3 months vs 7.2 months, p <0.001) was significantly prolonged. In addition, an interim analysis of data, compared with Zelboraf + placebo group, Cotellic + Zelboraf combination therapy group was significantly prolonged overall survival (OS, p = 0.0019), objective response rate (ORR: 70% vs 50%, p <0.001), complete remission rate (16% vs 11%) higher. The study's final overall survival (OS) analysis of the data will be submitted to the 2015 International Conference on Melanoma Research Society (SMR), held 18-21 November 2015 in California.
cobimetinib is an oral small molecule MEK inhibitors, MEK is a protein kinase, is a part of RAS-RAF-MEK-ERK signaling pathway, this pathway can promote the division and cell survival in human cancer (including melanoma) in often active. cobimetinib designed to selectively block the activity of MEK protein, thereby blocking signal transduction pathways downstream.