Prostate cancer is the most common male malignancy, the current
traditional diagnostic methods for prostate cancer is serum-specific
antigen (PSA) concentrations were higher in patients with PSA biopsy
final diagnosis.
However,
the main disadvantage of this method is poor specificity of PSA (PSA
4-10ng / ml, the specificity of only 25% -40%), other issues such as
prostatitis, benign prostatic hyperplasia and other prostate disease can
also cause abnormal PSA concentration , it will often unnecessary biopsy to patients caused great suffering. Therefore, an urgent need to find a sensitive and specific early diagnostic marker for prostate cancer.
Recently,
the Beijing Genomics Institute, Chinese Academy of Sciences Laboratory
of Genomic Medicine precision Sun Yingli group in cooperation with the
Shanghai Second Military Medical University, Changhai Hospital, through
the Y chromosome methylation analysis and comparison of 66 pairs of
prostate cancer and paraneoplastic samples, found prostate cancer in specific methylation sites.
The
study by side comparison of cancer methylation levels between samples,
found some relatively conservative methylation sites on the Y
chromosome, which in methylation levels between different individuals is
almost the same, regardless of age and geographical Effect
of other factors, but these relatively conservative paracancerous
sample methylation sites in cancer samples has undergone a significant
variation in methylation, and screened a total of six conserved in
paraneoplastic and in cancer Changes in specific sites.
After further DNA testing to verify the urine, the researchers finally selected a specific methylation sites. Its
receiver characteristic curve (ROC) analysis showed that the site of
prostate cancer diagnosis sensitivity and specificity were 94.6% and
reached 78.3%, far superior to the traditional PSA method, and the
method is to detect through urine samples, are a non-invasive means of non-invasive detection of liquid.
Liquid
biopsy is currently the non-invasive diagnostic research focus has
broad application prospects, is an inevitable trend in the future development of molecular diagnostic techniques. DNA methylation detection with strong tissue specificity, and
therefore has a unique advantage in liquid biopsy applications, will
become cancer diagnosis, prognosis and an important means of detecting
treatment.
At
present, domestic and international differences in DNA methylation in
the urine for the diagnosis of prostate cancer is still blank, so the
study leading level. In
related research Identification of specific DNA methylation sites on
the Y-chromosome as biomarker in prostate cancer in the title published
in the journal oncotarget. The
study was Ministry of Science and Basic Research Program of China
(973), strategic pilot projects funded Chinese Academy of Sciences,
National Natural Science Foundation and other projects.
( Bolise Co., Ltd. www.chemicalspharm.com )
2015年11月23日星期一
Four Gilead HIV approved new drug Genvoya eligible for Europe, effective, and more secure
Gilead
is the absolute leader in the field of AIDS treatment, the company
developed the drug Four Stribild (E / C / F / TDF) in 2012 and 2013 have
been listed in the United States and Europe the second largest market,
greatly simplifying HIV The treatment procedures. This
month, the newly developed Four Gilead HIV DRUG Genvoya (E / C / F /
TAF) in the United States and the EU regulation have been big news came:
the 5th of this month, Genvoya obtain FDA approval; on the 23rd of this
month , Genvoya re-approved by the EU:
- The United States, Genvoya crowd is: never received treatment HIV-1 infected adults, aged 12 and older weighing at least 35 kilograms of HIV-1 infection among adolescents, as well as HIV-1 virus is currently being inhibited HIV- 1 adult infection.- EU, Genvoya crowd as: HIV-1 infected adults, aged 12 and older weighing at least 35 kilograms of adolescent HIV-1 infection, the condition does not exist and integrase inhibitors emtricitabine or tenofovir Wei mutations associated with resistance to any.
In clinical trials, Genvoya (E / C / F / TAF) comparable efficacy Stribild (E / C / F / TDF), while improving kidney and skeletal parameters, higher security, a wider application of the crowd, the drug will become Gilead HIV franchise in another Reggie, is a new gospel of global HIV community.
- The United States, Genvoya crowd is: never received treatment HIV-1 infected adults, aged 12 and older weighing at least 35 kilograms of HIV-1 infection among adolescents, as well as HIV-1 virus is currently being inhibited HIV- 1 adult infection.- EU, Genvoya crowd as: HIV-1 infected adults, aged 12 and older weighing at least 35 kilograms of adolescent HIV-1 infection, the condition does not exist and integrase inhibitors emtricitabine or tenofovir Wei mutations associated with resistance to any.
In clinical trials, Genvoya (E / C / F / TAF) comparable efficacy Stribild (E / C / F / TDF), while improving kidney and skeletal parameters, higher security, a wider application of the crowd, the drug will become Gilead HIV franchise in another Reggie, is a new gospel of global HIV community.
Drug sales, the fawn male or female?
EC pharmaceutical sales strategy emphasizes, must be firmly fixed on
the female consumer groups, firmly grasp their wallets, because they
control the family purse strings.
However, the media recently named by ID Media's survey found that men also have demand to buy drugs, and medical decisions in the family, men play a more active role. ID Media, according to data collected show, when faced with drug ads or health-related information, the male is superior to women in many aspects.
Although compared with men, women buy a larger proportion of prescription drugs --52% VS35%, but men pay more attention to drug sales and related information.
For example, 68% of men believe they have a responsibility to understand the doctor's prescription, while only 60 percent of the female population have this consciousness. In addition, 54% of men said that when they decide what to buy medicines, will get valuable advice from the drug information, while only 47 percent of women have this experience. Buy prescription drugs, consumer groups, 48% of men will study prescription drug information on its Web site, while only 37 percent of women said they would do so.
Senior director of media strategy at ID Media's Michael Baliber said that advances in technology prompted men and women through the Internet relevant medical information, especially mobile universal client, making men more access to the medical information, and participate in decision-making.
The study also revealed differences between men of different ages in the drug buy respect. There is no doubt that men aged 18-34 than in men 35-64 years of age are more easily accepted drug sales and related information. Male 18-34 age group, 41% said they were to focus on the development of new drugs and medical information through TV, print and online advertising, while in the male population in the 35-64 age group, the rate is only It is 23%. In addition, young people represent drug advertising will encourage them to consult a physician drug-related information, and the previous generation of the population, only 22 percent have this habit.
Interestingly, 71% of the previous generation of the crowd, said to the doctor to understand the knowledge of prescription drugs is their responsibility, while only 63% of young people think so.
These data illustrate what? This is the ID Media next research plan. They will be carried out to test for digital media men and women, and different groups of men.
In any case, this survey suggests that pharmaceutical sales department to change the stereotype, based on the new features of technology and social development to adjust the marketing strategy.
However, the media recently named by ID Media's survey found that men also have demand to buy drugs, and medical decisions in the family, men play a more active role. ID Media, according to data collected show, when faced with drug ads or health-related information, the male is superior to women in many aspects.
Although compared with men, women buy a larger proportion of prescription drugs --52% VS35%, but men pay more attention to drug sales and related information.
For example, 68% of men believe they have a responsibility to understand the doctor's prescription, while only 60 percent of the female population have this consciousness. In addition, 54% of men said that when they decide what to buy medicines, will get valuable advice from the drug information, while only 47 percent of women have this experience. Buy prescription drugs, consumer groups, 48% of men will study prescription drug information on its Web site, while only 37 percent of women said they would do so.
Senior director of media strategy at ID Media's Michael Baliber said that advances in technology prompted men and women through the Internet relevant medical information, especially mobile universal client, making men more access to the medical information, and participate in decision-making.
The study also revealed differences between men of different ages in the drug buy respect. There is no doubt that men aged 18-34 than in men 35-64 years of age are more easily accepted drug sales and related information. Male 18-34 age group, 41% said they were to focus on the development of new drugs and medical information through TV, print and online advertising, while in the male population in the 35-64 age group, the rate is only It is 23%. In addition, young people represent drug advertising will encourage them to consult a physician drug-related information, and the previous generation of the population, only 22 percent have this habit.
Interestingly, 71% of the previous generation of the crowd, said to the doctor to understand the knowledge of prescription drugs is their responsibility, while only 63% of young people think so.
These data illustrate what? This is the ID Media next research plan. They will be carried out to test for digital media men and women, and different groups of men.
In any case, this survey suggests that pharmaceutical sales department to change the stereotype, based on the new features of technology and social development to adjust the marketing strategy.
Amgen fell by NICE for Repatha said no!
In the latest NICE guidance published in, Repatha failed to get praise managers. The reason for this is due to two things. First, the existing data from clinical studies failed to demonstrate its efficacy. Although Repatha in reducing bad cholesterol remarkable achievements,
but there is no evidence that these cholesterol levels by lowering the
risk of the user can reduce angina, heart disease.
In addition, some analytical methods Repatha NICE also been questioned, for example, in the study Amgen researchers used the Framingham assessment criteria rather than NICE recommended to analyze the efficacy of the drug. Therefore, managers also need to wait until the second half of 2016 in order to lower the effect of conclusion. Secondly, PCSK9 drugs a listing of its high price, let everyone stunned. Patients need to pay £ 4,448.60 (140mg receiving treatment every two weeks) or £ 6,123.60 (420mg receiving monthly treatment), the high price for NICE unacceptable.
In fact, PCSK9 price issue has so many people criticized. Whether Repatha or Sanofi / regeneration yuan's Repatha are so patient and kind of health insurance companies to be "robbed" feeling. In the US, the pricing of these two drugs were $ 14,100 / year and $ 14,600 / year. The estimated non-profit organization Institute for Clinical and Economic Review, the reasonable price range of these two drugs should be between $ 3,615- $ 4,811.
Although Amgen is working with various aspects Repatha approached in terms of price, but it is clear that companies also need to show more sincerity.
( Bolise Co., Ltd. www.chemicalspharm.com )
In addition, some analytical methods Repatha NICE also been questioned, for example, in the study Amgen researchers used the Framingham assessment criteria rather than NICE recommended to analyze the efficacy of the drug. Therefore, managers also need to wait until the second half of 2016 in order to lower the effect of conclusion. Secondly, PCSK9 drugs a listing of its high price, let everyone stunned. Patients need to pay £ 4,448.60 (140mg receiving treatment every two weeks) or £ 6,123.60 (420mg receiving monthly treatment), the high price for NICE unacceptable.
In fact, PCSK9 price issue has so many people criticized. Whether Repatha or Sanofi / regeneration yuan's Repatha are so patient and kind of health insurance companies to be "robbed" feeling. In the US, the pricing of these two drugs were $ 14,100 / year and $ 14,600 / year. The estimated non-profit organization Institute for Clinical and Economic Review, the reasonable price range of these two drugs should be between $ 3,615- $ 4,811.
Although Amgen is working with various aspects Repatha approached in terms of price, but it is clear that companies also need to show more sincerity.
( Bolise Co., Ltd. www.chemicalspharm.com )
Once contraception for 5 years! Bayer submitted a listing application of long-term intrauterine device
German
pharmaceutical giant Bayer (Bayer) today announced that the European
Union and the United States has been submitted to regulators listing
application of new long-acting intrauterine device LCS-16, which is a
new low-dose levonorgestrel releasing intrauterine system (LNG-IUS), placed directly in the uterus, can provide up to 5 years of contraception. LNG-IUS is one of the most effective long-term contraceptive methods,
can be removed at any time, after removing the women can quickly return
to normal fertility.
LCS-16 is a small flexible plastic T-shaped device, once placed in the uterus, can release a low dose of progestin levonorgestrel, can provide up to 5 years of contraception. LCS-16 after removal, women can quickly return to normal fertility.
Phase III clinical program LCS-16, involving countries from North America and Europe, 574 cases of nulliparous (nulliparous) and 878 cases of maternal (parous), the primary endpoint of the clinical program for the introduction of Pearl Index (Pearl Index, PI) Evaluation The contraceptive effect. Data show that, LCS-16 contraceptive efficiency of over 98.5%, 3-year Pearl index was 0.31, 5-year Pearl index was 0.29. Study, LCS-16 overall well tolerated, unexpected adverse events occurred.
In April this year, generics giant Actavis (Actavis) in the United States launched a new intrauterine drug delivery device (IUD) Liletta, placed into the uterus after, can provide up to three years of contraception. In IUS study in Phase III ACCESS, Liletta duration of three years effective contraception up to 99.45%, after using the body mass index and women (BMI) no significant change. Currently, the study continues to evaluate Liletta use up to four years, five years, seven years of contraceptive efficacy and safety.
( Bolise Co., Ltd. www.chemicalspharm.com )
LCS-16 is a small flexible plastic T-shaped device, once placed in the uterus, can release a low dose of progestin levonorgestrel, can provide up to 5 years of contraception. LCS-16 after removal, women can quickly return to normal fertility.
Phase III clinical program LCS-16, involving countries from North America and Europe, 574 cases of nulliparous (nulliparous) and 878 cases of maternal (parous), the primary endpoint of the clinical program for the introduction of Pearl Index (Pearl Index, PI) Evaluation The contraceptive effect. Data show that, LCS-16 contraceptive efficiency of over 98.5%, 3-year Pearl index was 0.31, 5-year Pearl index was 0.29. Study, LCS-16 overall well tolerated, unexpected adverse events occurred.
In April this year, generics giant Actavis (Actavis) in the United States launched a new intrauterine drug delivery device (IUD) Liletta, placed into the uterus after, can provide up to three years of contraception. In IUS study in Phase III ACCESS, Liletta duration of three years effective contraception up to 99.45%, after using the body mass index and women (BMI) no significant change. Currently, the study continues to evaluate Liletta use up to four years, five years, seven years of contraceptive efficacy and safety.
( Bolise Co., Ltd. www.chemicalspharm.com )
2015年11月22日星期日
$ 150 billion! The pharmaceutical industry's largest merger finalized!
Pfizer
to $ 150 billion takeover deal finally reached El build, he is expected
to sign the approval of the boards of both companies on Sunday. It will also become the pharmaceutical industry's largest merger.
According to Friday's closing price of Pfizer, Ayr build than October 28 closing price of 27% of the premium. Pfizer and Al ratio of convertible plans to build 11.3: 1. The deal also involves a small portion of cash, accounts for less than 10% of the transaction price.
The acquisition of small and large, the American company Pfizer headquarters to pave the way for Ireland to achieve revenue upside (US tax rate of 35%, the Irish tax rate of 12.5%). However, in view of the transaction created the largest ever recorded medical industry, but also coincides with a key moment in American presidential election, it will inevitably lead to some controversy. In addition, Al Jian CEO Brent Saunders has caused controversy in the research and development of pharmaceutical companies. He specializes in asset transactions, corporate internal drug development skepticism future strategy after joining the new company may be subject to change.
Informed sources said Pfizer CEO Ian Read will serve as CEO of the new company, Al-built CEO Brent Saunders will serve a very senior position in the company's operations and integration, and also in the combined The Board of Directors take place.
The transaction would create an annual sales exceeding $ 60 billion pharmaceutical giant, the combined group will be ahead of the second largest US pharmaceutical companies Merck (Merck & Co), which generated sales of $ 40 billion.
( Bolise Co., Ltd. www.chemicalspharm.com )
According to Friday's closing price of Pfizer, Ayr build than October 28 closing price of 27% of the premium. Pfizer and Al ratio of convertible plans to build 11.3: 1. The deal also involves a small portion of cash, accounts for less than 10% of the transaction price.
The acquisition of small and large, the American company Pfizer headquarters to pave the way for Ireland to achieve revenue upside (US tax rate of 35%, the Irish tax rate of 12.5%). However, in view of the transaction created the largest ever recorded medical industry, but also coincides with a key moment in American presidential election, it will inevitably lead to some controversy. In addition, Al Jian CEO Brent Saunders has caused controversy in the research and development of pharmaceutical companies. He specializes in asset transactions, corporate internal drug development skepticism future strategy after joining the new company may be subject to change.
Informed sources said Pfizer CEO Ian Read will serve as CEO of the new company, Al-built CEO Brent Saunders will serve a very senior position in the company's operations and integration, and also in the combined The Board of Directors take place.
The transaction would create an annual sales exceeding $ 60 billion pharmaceutical giant, the combined group will be ahead of the second largest US pharmaceutical companies Merck (Merck & Co), which generated sales of $ 40 billion.
( Bolise Co., Ltd. www.chemicalspharm.com )
Genentech, Novartis, Ophthotech jointly develop three rows | broad prospects drugs pegpleranib
With
the popularity of computers and mobile phones, people are spending more
and more time to spend in the electrical equipment. However, for a long time watching the screen also allows the eye overwhelmed. In recent years, eye disease patient population size has been a growing trend. Therefore, more and more companies began to strengthen in the biomedical aspects of eye disease research, especially with the
age-related eye diseases.
Roche's Genentech recently announced that it would invest Ophthotech company for the treatment of age-related macular degeneration (AMD) new drug Pegpleranib, and will be another pharmaceutical giant Novartis share this medicine overseas copyright.
Is sought after the two giants pegpleranib is currently in two Phase III clinical studies. Researchers are evaluated on the drug and Genentech's Lucentis combined with the effect. Pegpleranib is an anti-platelet-derived growth factor, can prevent blood vessels associated with AMD mistake growth. The Lucentis is a vascular endothelial growth factor inhibitor drugs. Ophthotech company believes this two drugs can play a good synergy in AMD treatment. Two clinical studies expected to be completed in the fourth quarter of 2017. In addition, the company will phase III clinical study with Roche's Avastin Eylea pegpleranib and regeneration of dollars and will be combined with.
As early as in 2014, Novartis and Ophthotech company seeking to develop the drug reached a cooperation agreement. Novartis to Ophthotech company paid $ 200 million in advances and milestones of up to $ 800 million in prize money. On the other hand, Novartis added for Genentech surely welcomed. Since early in 2003, Novartis gained the right to sell Lucentis outside the US from Genentech aspect, so this will also join the Genentech makes tripartite more smoothly in the drug development.
( Bolise Co., Ltd. www.chemicalspharm.com )
Roche's Genentech recently announced that it would invest Ophthotech company for the treatment of age-related macular degeneration (AMD) new drug Pegpleranib, and will be another pharmaceutical giant Novartis share this medicine overseas copyright.
Is sought after the two giants pegpleranib is currently in two Phase III clinical studies. Researchers are evaluated on the drug and Genentech's Lucentis combined with the effect. Pegpleranib is an anti-platelet-derived growth factor, can prevent blood vessels associated with AMD mistake growth. The Lucentis is a vascular endothelial growth factor inhibitor drugs. Ophthotech company believes this two drugs can play a good synergy in AMD treatment. Two clinical studies expected to be completed in the fourth quarter of 2017. In addition, the company will phase III clinical study with Roche's Avastin Eylea pegpleranib and regeneration of dollars and will be combined with.
As early as in 2014, Novartis and Ophthotech company seeking to develop the drug reached a cooperation agreement. Novartis to Ophthotech company paid $ 200 million in advances and milestones of up to $ 800 million in prize money. On the other hand, Novartis added for Genentech surely welcomed. Since early in 2003, Novartis gained the right to sell Lucentis outside the US from Genentech aspect, so this will also join the Genentech makes tripartite more smoothly in the drug development.
( Bolise Co., Ltd. www.chemicalspharm.com )
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