02 April 2011
FDA Fast Track designations granted for both: the protease viagra cialis online pharmacy pharmacy BI 201335 plus standard-of-care and the interferon-free combination of BI 201335 with polymerase inhibitor, BI 207127
Not for U.S. media
INGELHEIM, Germany, 2 April 2011 – Boehringer Ingelheim today announced the study outline for the pivotal Phase III clinical trials designed to evaluate BI 201335, its investigational once-daily oral protease inhibitor, in both treatment-naïve and -experienced patients with chronic genotype-1 hepatitis C virus (HCV), the most challenging genotype to treat.
In parallel, the U.S. Food and Drug Administration (FDA) has granted Fast Track designations for BI 201335 plus standard-of care (SOC), and as part of the interferon-free combination with the polymerase inhibitor, BI 207127, in chronic genotype-1 HCV patients.
"We are delighted to receive the FDA’s Fast Track designation for both, our BI 201335 plus SOC, and interferon-free combination treatment approaches. If successful, the combination therapy carries the potential for patients to live without the burden of interferon’s side effects," said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim.
"We are committed to bringing BI 201335 forward, with the ambition of improving cure rates for the benefit of those living with hepatitis C."
BI 201335 Phase III Trials*
BI 201335 will be evaluated in multiple randomised, double-blind, placebo-controlled trials in combination with pegylated-interferon and ribavirin (PegIFN/RBV), the current HCV SOC. The Phase III trials include two studies in treatment- naïve and one study in treatment-experienced chronic genotype-1 HCV patients. The two studies in treatment-naïve patients will be conducted in the European Union and Japan, as well as the U.S., Canada, Taiwan and Korea. The study in treatment-experienced patients will be conducted globally. BI 201335 will be dosed once-daily at either 120mg or 240mg in combination with PegIFN/RBV and treatment durations will range from 24 to 48 weeks. The primary endpoint of each trial is sustained viral response (SVR), which is considered viral cure. These studies are part of a broader Phase III trial programme expected to commence in the second quarter of 2011.
PegIFN-Free Phase II Trials of BI 201335 + BI 207127
In parallel, Boehringer Ingelheim is developing BI 207127, an oral HCV polymerase inhibitor that has completed Phase I clinical trials in combination with BI 201335. Phase II trials evaluating BI 207127 plus BI 201335 in PegIFN-free regimens, both with and without ribavirin, are currently underway. The FDA has designated this investigation as a Fast Track development programme. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to patients earlier.
About Hepatitis C Virus (HCV)
HCV is an infectious disease of the liver and is a leading cause of chronic liver disease and liver transplant. The number of individuals chronically infected with HCV globally has been estimated at 170 million, with 3–4 million new infections occurring each year. Only about 20–45% of patients clear the virus in the acute phase. Of the remaining chronically infected patients, 20% will develop cirrhosis within a mean of 20 years. The mortality rate after cirrhosis has developed is 2-5% per year. End-stage liver disease due to HCV infection currently represents the major cause for liver transplantation in the Western world.
About Boehringer Ingelheim in Virology
Boehringer Ingelheim has more than 6,900 scientists working in cross disciplinary teams within our global R&D network in six large therapeutic areas, including virology. In addition to its ongoing research programme for HCV, Boehringer Ingelheim has a long-standing history in virology drug development, including compounds for the treatment of HIV (VIRAMUNE® (nevirapine) tablets/oral suspension, the first approved HIV non-nucleoside reverse transcriptase inhibitor (NNRTI) and Aptivus®, an HIV protease inhibitor). The company has a well established research centre in Laval, Canada, dedicated to virology research since the early 1990’s, and is committed to developing new therapies for virological diseases with a high unmet medical need.
Boehringer Ingelheim in Hepatitis C Virus (HCV)
BI 201335 is an investigational oral HCV NS3/4A protease inhibitor, discovered from Boehringer Ingelheim’s own research and development, which has completed clinical trials through Phase IIb (SILEN-C studies). This Phase II programme supports the investigation of BI 201335 in Phase III trials. Boehringer Ingelheim is also developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has completed Phase I clinical trials. Phase II trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, both with and without ribavirin, are currently underway.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro (US $17.7 billion) while spending 21% of net sales in its largest business segment, Prescription Medicines, on research and development.
For more information, please visit http://www.boehringer-ingelheim.com/
www.twitter.com/boehringer
*Final results of the Phase II studies SILEN-C1 and SILEN-C2 for BI 201335 were presented yesterday at the International Liver Congress TM 2011, the 46 th Annual Meeting of the European Association for the study of the liver (EASL) in Berlin.
Source
Thứ Ba, 1 tháng 11, 2011
Thứ Bảy, 29 tháng 10, 2011
Health and Hospital Systems Board Meeting
December 17, 2010
The meeting was called to order shortly after 7:30am by Chairman Batts. Only 1 public speaker before the Board got to the business of Committee Reports.
Finance Committee
A contract with Hektoen Institute of Medicine was included for approval. Hektoen oversees research grants within the system and the Board had determined that an agreement between Hektoen and HHS was needed to establish control over the grant monies involved. While it was reported that Hektoen was not satisfied with the contract Director Carvalho, Finance Committee Chair, asked for approval anyway stating that “change is hard.”
The Board had questions about the loss of medicaide revenue as reported in the Financial Statements for September and October – a total of $55m for the year to date. Mr. Ayres, the CFO, stated that he could do some analysis but he had no hypothesis as to why there was a decrease. Mr Foley, CEO for the system, stated that a major issue was the back log at the state in processing of medicaide applications for eligibility. He said they were trying to get an agreement wherein the County would provide funds for processing of eligibility that would presumably result in a net gain of funds if more applicants were found eligible. Further discussion revealed that this fall off in medicaide revenue is not being seen at other hospitals and that there may be other reasons for why the System is experiencing this decrease in medicaide revenue. There was also a reported decrease in patient online pharmacy viagra days which resulted in a discussion of whether the financial reports reflect actual patient days in the hospital or billed hospital days. There seemed to be confusion over the way that patient days are recorded in the financial reports and the confusion did not appear to be resolved.
Audit and Compliance Committee
It was reported that the committee is anxious to get started on the audit of Hektoen.
Chairman’s Report
Mr. Batts received a letter from the leadership of SEIU. They had done a budget analysis of the HHS proposed budget and sent their budget recommendations to the Board and also included suggestions for geographic representation of membership on the HHS Board, a labor/management partnership, and a Safety Net Summit. A response letter from the Chairman was presented seeking Board support. A discussion among the Board members ensued in which they discussed the new administration’s request that they spend only 21% of their 2011 budget request in the first quarter of the fiscal year. The CFO reported that the spending as of the end of 2010 was consistent with this request if they continued in the same pattern. Mr. Foley stated that reductions in spending may be less challenging as the year progresses when parts of Provident and Oak Forest are closed later in the year. It was also pointed out that more revenue is needed in the next few years to get the Strategic Plan moving forward and if that doesn’t happen this Independent Board will be perceived as doing the same old thing. Other directors pointed out that it was necessary to hear what different constituencies were saying and to get the community to work with them, although it was also pointed out that sometimes the community that claims they haven’t been heard is saying “you didn’t do what we wanted you to do”. Another opinion expressed was that you can do all the communicating you want but if you don’t deliver service it won’t make any difference.
Systems Operational Plan Update
A presentation was given by Dr. Schrader from the Emergency Dept. and a representative from Price Waterhouse on Simulation Modeling that has been done in the Emergency Room. Monitoring of all processes in the ER from when a patient walks in to when they are discharged from the ER was done during a 2 week period in October. Analysis was done to determine where processes could be expedited and some changes have already been instituted to decrease wait times and to expedite the time for tests so the patients can be moved through the ER in a more efficient manner. The big obstacle continues to be bed availability for patients that need to be admitted. Mr. Foley said that issue was being addressed in a different way.
Employee Engagement Survey
A system wide Employee Engagement Survey will be done in January. Such a survey has not been done recently and it will provide a baseline for further evaluation of employee satisfaction. It is being conducted by the survey arm of Price Waterhouse Coopers. The computerized survey has 50 questions and will take 20-30 minutes to complete, and participation is not required but strongly encouraged. The survey process will begin on January 12 and run for 10 days, with the hope of presenting the aggregate data results to the Board by March. Training will also be provided to managers so that they can utilize data gleaned to develop departmental goals which are in line with the Strategic Plan 2015 Vision.
HHS System Compensation Review
Mr. Foley stated that there has been a heightened level of concern regarding compensation levels within the HHS. The CC Board approved an ordinance requesting the County Auditor do an audit of the appropriateness of compensation packages in HHS. The President’s office will outline the scope of the audit. They have requested that it include comparisons to other large public hospitals. The CC Board wants this completed by Jan. 19 so they will have the information prior to their consideration of the budget. It was pointed out that comparisons have been done based on similar positions in the Chicago area and not on similar hospitals in other locations. This is consistent with comparisons for other personnel salaries that are also based on location (Chicago) and not type of institution (public hospitals in other cities). The scope remains to be determined, and it is not clear what the President and the CC Board will do with the information once they have it.
Observer left at 9:15am and board was still meeting with 1 remaining item on agenda before going into closed session.
Cynthia Schilsky
LWVCC Observer
The meeting was called to order shortly after 7:30am by Chairman Batts. Only 1 public speaker before the Board got to the business of Committee Reports.
Finance Committee
A contract with Hektoen Institute of Medicine was included for approval. Hektoen oversees research grants within the system and the Board had determined that an agreement between Hektoen and HHS was needed to establish control over the grant monies involved. While it was reported that Hektoen was not satisfied with the contract Director Carvalho, Finance Committee Chair, asked for approval anyway stating that “change is hard.”
The Board had questions about the loss of medicaide revenue as reported in the Financial Statements for September and October – a total of $55m for the year to date. Mr. Ayres, the CFO, stated that he could do some analysis but he had no hypothesis as to why there was a decrease. Mr Foley, CEO for the system, stated that a major issue was the back log at the state in processing of medicaide applications for eligibility. He said they were trying to get an agreement wherein the County would provide funds for processing of eligibility that would presumably result in a net gain of funds if more applicants were found eligible. Further discussion revealed that this fall off in medicaide revenue is not being seen at other hospitals and that there may be other reasons for why the System is experiencing this decrease in medicaide revenue. There was also a reported decrease in patient online pharmacy viagra days which resulted in a discussion of whether the financial reports reflect actual patient days in the hospital or billed hospital days. There seemed to be confusion over the way that patient days are recorded in the financial reports and the confusion did not appear to be resolved.
Audit and Compliance Committee
It was reported that the committee is anxious to get started on the audit of Hektoen.
Chairman’s Report
Mr. Batts received a letter from the leadership of SEIU. They had done a budget analysis of the HHS proposed budget and sent their budget recommendations to the Board and also included suggestions for geographic representation of membership on the HHS Board, a labor/management partnership, and a Safety Net Summit. A response letter from the Chairman was presented seeking Board support. A discussion among the Board members ensued in which they discussed the new administration’s request that they spend only 21% of their 2011 budget request in the first quarter of the fiscal year. The CFO reported that the spending as of the end of 2010 was consistent with this request if they continued in the same pattern. Mr. Foley stated that reductions in spending may be less challenging as the year progresses when parts of Provident and Oak Forest are closed later in the year. It was also pointed out that more revenue is needed in the next few years to get the Strategic Plan moving forward and if that doesn’t happen this Independent Board will be perceived as doing the same old thing. Other directors pointed out that it was necessary to hear what different constituencies were saying and to get the community to work with them, although it was also pointed out that sometimes the community that claims they haven’t been heard is saying “you didn’t do what we wanted you to do”. Another opinion expressed was that you can do all the communicating you want but if you don’t deliver service it won’t make any difference.
Systems Operational Plan Update
A presentation was given by Dr. Schrader from the Emergency Dept. and a representative from Price Waterhouse on Simulation Modeling that has been done in the Emergency Room. Monitoring of all processes in the ER from when a patient walks in to when they are discharged from the ER was done during a 2 week period in October. Analysis was done to determine where processes could be expedited and some changes have already been instituted to decrease wait times and to expedite the time for tests so the patients can be moved through the ER in a more efficient manner. The big obstacle continues to be bed availability for patients that need to be admitted. Mr. Foley said that issue was being addressed in a different way.
Employee Engagement Survey
A system wide Employee Engagement Survey will be done in January. Such a survey has not been done recently and it will provide a baseline for further evaluation of employee satisfaction. It is being conducted by the survey arm of Price Waterhouse Coopers. The computerized survey has 50 questions and will take 20-30 minutes to complete, and participation is not required but strongly encouraged. The survey process will begin on January 12 and run for 10 days, with the hope of presenting the aggregate data results to the Board by March. Training will also be provided to managers so that they can utilize data gleaned to develop departmental goals which are in line with the Strategic Plan 2015 Vision.
HHS System Compensation Review
Mr. Foley stated that there has been a heightened level of concern regarding compensation levels within the HHS. The CC Board approved an ordinance requesting the County Auditor do an audit of the appropriateness of compensation packages in HHS. The President’s office will outline the scope of the audit. They have requested that it include comparisons to other large public hospitals. The CC Board wants this completed by Jan. 19 so they will have the information prior to their consideration of the budget. It was pointed out that comparisons have been done based on similar positions in the Chicago area and not on similar hospitals in other locations. This is consistent with comparisons for other personnel salaries that are also based on location (Chicago) and not type of institution (public hospitals in other cities). The scope remains to be determined, and it is not clear what the President and the CC Board will do with the information once they have it.
Observer left at 9:15am and board was still meeting with 1 remaining item on agenda before going into closed session.
Cynthia Schilsky
LWVCC Observer
Thứ Hai, 23 tháng 5, 2011
Graduate Program in Sexual Health wins award at WAS 2009
See also: cialis |
I have just returned from the World Association for Sexual cheap viagra Congress in Gotenberg Sweden.
The BIG news in that our program was awarded the WAS AWARD FOR EXCELLENCE & INNOVATION IN SEXUALITY EDUCATION 2009.
This is the equivalent of winning an Oscar award for sex education.
Do let me know (P.Weerakoon@usyd.edu.au) if you want to be a part of this award winning group.
I have just returned from the World Association for Sexual cheap viagra Congress in Gotenberg Sweden.
The BIG news in that our program was awarded the WAS AWARD FOR EXCELLENCE & INNOVATION IN SEXUALITY EDUCATION 2009.
This is the equivalent of winning an Oscar award for sex education.
Do let me know (P.Weerakoon@usyd.edu.au) if you want to be a part of this award winning group.
Thứ Ba, 3 tháng 5, 2011
A Penis Free Columbia
See also: cialis |
Hey guys! Time for a quick update.
So I have been orienting my ass off for 8 hours a day since last Friday. I dont start actual work until this coming Monday. Last Friday, Monday, and Tuesday were my OB/GYN orientation days and Wed, Thursday, and Friday are my hospital orientation days. The hospital orientation days are extra-painful for me since I went to school here and am already VERY acquainted with Palmetto Richland hospital. Anyways, during my OB/GYN orientation we got our rotation schedule for the next 12 months. We have 10 months on-service (OB, GYN, Night Float, or Ultrasound) and 2 months off-service (Family Practice). I had specifically requested months ago to start on-service because I wanted to jump right in and not feel left out. So what did I get assigned to first? Why, Family Practice, of course. That OK though because our family practice months are pretty chill. We are just assigned to work in the outpatient clinic everyday and take OB call every other weekend. So, I found out that because I am the resident on FP, I am also in charge of castrating (circumsizing) all the newborn boys in the hospital. I almost had a panic attack when I got this news. I got no problem operating on an old lady for 6 hours, but the thought of accidentally castrating a newborn is terrifying to me. The picture you see above is the torture device we use for removing the excess skinnage on the babies, called the gomco. I was so nervous when I found I had to start off doing this that I had one of the attendings take me over to the newborn nursery so I could practice a few rounds. Well, after the bleeding and screaming finally stopped, I noticed that I had actually created a very nice looking order cialis for Baby Boy X. I think he will make some lucky woman very happy one day. However, even after my success I am still extremely shaky about the whole thing, so a little word to the wise. If you are reading this blog and about to pop out a baby, you might want to avoid Palmetto Richland for about a month or so. That is, if you want to be guaranteed that your little boy will be able to have children someday. Just damn.
FDA APPROVES IMPOTENCE PILL, VIAGRA
The Food and Drug Administration today announced the approval of purchase cialis (sildenafil citrate), the first oral pill to treat impotence, a dysfunction that affects millions of men in the United States.
Unlike previously approved treatments for impotence, cialis does not directly cause penile erections, but affects the response to sexual stimulation. The drug acts by enhancing the smooth muscle relaxant effects of nitric oxide, a chemical that is normally released in response to sexual stimulation. This smooth muscle relaxation allows increased blood flow into certain areas of the penis leading to an erection.
Viagra was evaluated in numerous randomized, placebo controlled trials involving more than 3000 men with varying degrees of impotence associated with diabetes, spinal cord injury, history of prostate surgery, and no identifiable organic cause of impotence. Patients also had a wide range of other concomitant illnesses including hypertension and coronary artery disease.
The drug's effectiveness was assessed primarily using a sexual function questionnaire. Patients were asked to report at the beginning, and periodically throughout the studies, how often they were able to achieve an erection adequate for intercourse, and how often that erection was maintained after penetration. In addition, patients kept diaries of their sexual histories. In all trials, men on Viagra reported success more often than did men on placebo, and rates of success increased with dose. The findings were consistent in men representing a wide range of severity and etiology of their erectile dysfunction (impotence). Men with diabetes or radical prostate surgery had somewhat less improvement than did other groups.
The recommended dose is 50mg taken one hour before sexual activity; individuals may need more (100mg) or less (25 mg) and dosing should be determined by a physician depending on effectiveness and side effects. The drug should not be used more than once a day.
The most common side effects reported in clinical trials included headache, flushing, and indigestion, which occurred at a slightly higher rate in patients taking the drug than among those taking placebo. Some patients on Viagra (about 3 percent) also reported changes in vision, principally altered color perception.
The drug should not be used with organic nitrates such as nitroglycerin patches or sublingual tablets because the combination may lower blood pressure. The safety and efficacy of using Viagra with other treatments for impotence has not been studied, and the use of such combinations is not recommended.
Viagra confers no resistance to AIDS or other sexually transmitted diseases.
Before taking Viagra, patients are advised to:
Have a thorough medical history and physical examination to diagnose impotence, determine underlying causes and identify appropriate treatment, and
discuss the cardiac risk associated with sexual activity prior to initiating any treatment for impotence.Viagra is manufactured by Pfizer Pharmaceuticals, New York, NY. The product was approved by FDA in less than six months after submission. The FDA's clinical review of the studies, approval letter and labeling can be found on the internet at http://www.fda.gov/cder/news/viagra.htm.
Unlike previously approved treatments for impotence, cialis does not directly cause penile erections, but affects the response to sexual stimulation. The drug acts by enhancing the smooth muscle relaxant effects of nitric oxide, a chemical that is normally released in response to sexual stimulation. This smooth muscle relaxation allows increased blood flow into certain areas of the penis leading to an erection.
Viagra was evaluated in numerous randomized, placebo controlled trials involving more than 3000 men with varying degrees of impotence associated with diabetes, spinal cord injury, history of prostate surgery, and no identifiable organic cause of impotence. Patients also had a wide range of other concomitant illnesses including hypertension and coronary artery disease.
The drug's effectiveness was assessed primarily using a sexual function questionnaire. Patients were asked to report at the beginning, and periodically throughout the studies, how often they were able to achieve an erection adequate for intercourse, and how often that erection was maintained after penetration. In addition, patients kept diaries of their sexual histories. In all trials, men on Viagra reported success more often than did men on placebo, and rates of success increased with dose. The findings were consistent in men representing a wide range of severity and etiology of their erectile dysfunction (impotence). Men with diabetes or radical prostate surgery had somewhat less improvement than did other groups.
The recommended dose is 50mg taken one hour before sexual activity; individuals may need more (100mg) or less (25 mg) and dosing should be determined by a physician depending on effectiveness and side effects. The drug should not be used more than once a day.
The most common side effects reported in clinical trials included headache, flushing, and indigestion, which occurred at a slightly higher rate in patients taking the drug than among those taking placebo. Some patients on Viagra (about 3 percent) also reported changes in vision, principally altered color perception.
The drug should not be used with organic nitrates such as nitroglycerin patches or sublingual tablets because the combination may lower blood pressure. The safety and efficacy of using Viagra with other treatments for impotence has not been studied, and the use of such combinations is not recommended.
Viagra confers no resistance to AIDS or other sexually transmitted diseases.
Before taking Viagra, patients are advised to:
Have a thorough medical history and physical examination to diagnose impotence, determine underlying causes and identify appropriate treatment, and
discuss the cardiac risk associated with sexual activity prior to initiating any treatment for impotence.Viagra is manufactured by Pfizer Pharmaceuticals, New York, NY. The product was approved by FDA in less than six months after submission. The FDA's clinical review of the studies, approval letter and labeling can be found on the internet at http://www.fda.gov/cder/news/viagra.htm.
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