Hello Gentle People:
The Decorah Eagle is on her nest. If you visit now you will see a live video of her and her new Egg.
http://www.ustream.tv/decoraheagles?utm_source=crowd-live-backend&utm_medium=visit-channel&utm_campaign=notifications
http://www.ustream.tv/decoraheagles?utm_source=crowd-live-backend&utm_medium=visit-channel&utm_campaign=notifications
Thursday, February 19, 2015
Tuesday, February 17, 2015
Monday, February 16, 2015
Hello gentle friends:
When I was in elementary school way back in the 50's, I was lucky enough to receive a small cafeteria breakfast in the morning before going to class. Considering we were the baby boom generation with an average of Forty children to a class, receiving a free breakfast in the morning was short of miraculous! Today, there are still children going to school hungry in North America and it is our turn to provide a decent breakfast for these school children and for any hungry child we find anywhere on this planet. I found this on Twitter:
" When you realize that 60% of learning happens before lunch, it becomes clear why breakfast is indeed the most important meal of the day. When children get a balanced meal in a positive, stimulating environment, there are marked improvements in behaviour and concentration.
Academic performance, social skills, self-confidence and the ability to interact with peers and adults all improve when a child eats a nutritioius breakfast in the morning. Overall interest in the subjects being taught increase and incidents of bullying decrease."
Join the Breakfast Club:
http://www.breakfastclubcanada.org/
P.S. In the 1985 movie the "Breakfast Club" the male characters closely represented a collage of my own life!
When I was in elementary school way back in the 50's, I was lucky enough to receive a small cafeteria breakfast in the morning before going to class. Considering we were the baby boom generation with an average of Forty children to a class, receiving a free breakfast in the morning was short of miraculous! Today, there are still children going to school hungry in North America and it is our turn to provide a decent breakfast for these school children and for any hungry child we find anywhere on this planet. I found this on Twitter:
" When you realize that 60% of learning happens before lunch, it becomes clear why breakfast is indeed the most important meal of the day. When children get a balanced meal in a positive, stimulating environment, there are marked improvements in behaviour and concentration.
Academic performance, social skills, self-confidence and the ability to interact with peers and adults all improve when a child eats a nutritioius breakfast in the morning. Overall interest in the subjects being taught increase and incidents of bullying decrease."
Join the Breakfast Club:
http://www.breakfastclubcanada.org/
P.S. In the 1985 movie the "Breakfast Club" the male characters closely represented a collage of my own life!
Sunday, February 1, 2015
HELLO GENTLE READERS!
I am happy to report that consumer resistance is shrinking towards the new all Electric Tesla vehicles. Soon Tesla will be mass marketing all Electric vehicles with Four to Six hundred Kilometer range at prices meeting the economic capacity of middle class consumers.
They will be able to do that utilizing new light weight materials such as Graphene and Sylicone. While Tesla and the Japanese are planning ahead, General Motors will not be providing all Electric vehicles any time soon! They continue to value Gas engines and they want us to buy into their Volt and Bolt hype. In 2015 they are trying to sell us limited range Electric vehicles which carry Gas burning Electric generators. They are once again asking to be kicked down the road by the Japanese car companies. Find Craig Froehle's web site for a surprise!
Craig Froehle
Shared publicly - 12:05 AMTuesday, January 27, 2015
HERE IS ABSOLUTE PROOF OF GLOBAL WARMING.
Gentle readers:
Here is the absolute proof of global warming.
For those of you who may still doubt the existence of global warming, the following link will bring you absolute proof of global warming. It is far past the time we remove fossil fuels from our lives.
Here is the absolute proof of global warming.
For those of you who may still doubt the existence of global warming, the following link will bring you absolute proof of global warming. It is far past the time we remove fossil fuels from our lives.
The year 2014 was Earth’s warmest in 134 years of records, according to an analysis of surface temperature measurements by scientists at NASA’s Goddard Institute for Space Studies (GISS). In a separate, independent analysis, scientists at the National Oceanic and Atmospheric Administration (NOAA) also found 2014 to be the warmest on record. With the exception of 1998, the ten warmest years in the instrumental record (dating to 1880) have all occurred since 2000.
The map above depicts global temperature anomalies in 2014. It does not show absolute temperatures, but instead shows how much warmer or cooler the Earth was compared to a baseline average from 1951 to 1980. The GISS team assembles its analysis with publicly available data from roughly 6,300 meteorological stations around the world; ship- and buoy-based observations of sea surface temperature; and Antarctic research station measurements. This raw data is analyzed using an algorithm that takes into account the varied spacing of temperature stations around the globe and urban heating effects that could skew the calculation. For more explanation of how the analysis works, read World of Change: Global Temperatures.
“This is the latest in a series of warm years in a series of warm decades,” said GISS Director Gavin Schmidt. “While the ranking of individual years can be affected by chaotic weather patterns, the long-term trends are attributable to drivers of climate change that right now are dominated by human emissions of greenhouse gases.”
Since 1880, Earth’s average surface temperature has warmed by about 0.8 degrees Celsius (1.4 degrees Fahrenheit), a trend largely driven by the increase in carbon dioxide and other human emissions into the atmosphere. The majority of that warming has occurred in the past three or four decades, which is reflected in the NASA GISS data below.
Sunday, January 25, 2015
HELLO GENTLE PEOPLE!
Here is my international Index of great web sites. If some links don't work, try copying and pasting directly into Google.
10.= http://www.Ted.com
12. = http://www.Reuters.com
17. = http://www.wwfindia.org/
18. = http://www.youtube.com/watch?v=FhLa6O1OP0Y
21. = http://storyofstuff.org/
30.= http://www.iTooch.com How to greatly improve our school systems.
49. http://eol.org/50. http://www.seedsavers.org/onlinestore/
51. http://www.human4us.net/
52.https://www.youtube.com/watch?v=HiwI5k-gFwc
53. .http://www.emsl.pnnl.gov/emslweb/news/new-hypothesis-environmental-restoration.
Tuesday, January 13, 2015
http://eol.jsc.nasa.gov/DatabaseImages/ESC/small/ISS038/ISS038-E-38300.JPG
http://eol.jsc.nasa.gov/SearchPhotos/ShowQueryResults-ResponsiveImageGallery.pl?results=WeeklyTopPhotos
Hi gang!
You have got to take a look at this picture taken from the international space station. It is out of this world...literally!
Monday, January 5, 2015
FROM THE NASA EARTH OBSERVATORY.
Hello gentle readers, Australia is burning again! I feel terrible for the slow moving animals who won't be able to escape the wildfires. Check out the Earth Observatory below.
Shades of Pompei! In other news a volcano has erupted and buried a town in Fogo. I have not seen anything on my local news stations and so visit this web site..http://www.mrietze.com/web13/Fogo14.htm
[nh-weekly] 05 January 2015 -- Natural Hazards Updates
Shades of Pompei! In other news a volcano has erupted and buried a town in Fogo. I have not seen anything on my local news stations and so visit this web site..http://www.mrietze.com/web13/Fogo14.htm
[nh-weekly] 05 January 2015 -- Natural Hazards Updates
Wednesday, December 31, 2014
SHHHH SHHHHHH KEEP QUIET! DON'T TALK!
Shhhhhhhhhhhhhh Shhhhhhhhhhhh
"Keep quiet! Don't make waves! Do not disturb the powers that govern over us or they might take revenge and whatever you do don't go to the U.S. Supreme Court! It is controlled by lawyers who work for large self serving companies!" Check out the Reuters story at the bottom of this page.
O.K.! O.K! For the last few months I kept to a minimum my comments about global warming AND the horribly polluting Alberta Canada Tar Sands project and the XL Keystone Pipeline that will perpetuate the Oil industry for decades into the future along with the corruption within both our Canadian and U.S. federal governments. I also kept quiet about the Billions of Dollars wasted on military engagements in Iraq and Afghanistan and for what...for OIL to benefit a few top dogs in the food chain! I dare not mention the Bush family, the Koch brothers, the Chinese government's owned percentage of the Tar Sands or the Wall street Banks now back in the gambling business.
I also kept quiet about the lives lost and the soldiers wounded and maimed for life and the cost to low income tax payers war has created within both our countries. I did mourn the loss of Canada's world reputation as peace keepers and because of that I helped the N.D.P. win a local Canadian federal election but enough is enough! I will remain quiet no longer!.
In the past I used my computer ability to help a United States Senator win his election and thankfully he did some good work! He pushed through a Medicare insurance plan that has helped millions of U.S. citizens obtain medical insurance coverage and he passed Bills to stop Wall street from gambling with the life savings of average people. With a little persuasion Obama also helped a genius by the name of Elon Musk create a wonderful new machine known as the Tesla and that car is spreading around the world. It is so popular that Republican Congress leaders, backed by thir super rich friends, have reacted by slipping a dirty little Bill into the U.S. government budget that will give Wall street back the ability to once again gamble with other people's money. The first time the Banks did this the U.S. economy went down the tubes for years and thousands of people lost their homes.
Corruption continues to exist today within both our governments and the new U.S. Bill allows private investors to buy elections for hand picked local politicians. Within the U.S. government powerful Senators have promised to push through an Oil pipeline that will continue the use of fossil fuels here and around the world in spite of the fact that global warming is slowly changing the climate of our planet. Today, December 31, 2015, powerful self interest groups are winning within the U.S. government, however, they are not winning in Canada and they will lose the Tar Sands project and the XL pipeline when soon the Canadian federal Conservative government is deservedly kicked out of office. What I would like to see is Hilary Clinton win the White House and maintain and protect the laws that have protected average Americans from predatory Banks during the last few years. Gambling with life savings and pension funds is a crime and must remain a crime. I would also be over joyed if Hilary finally rid the world of fossil fuels and the dirty political influence they continue to exert on our governments. May the New Year bring you peace and a better way of life!
---------------------------------------------------------------------------------------------------
Reuters has an interesting story! It is how corporate America dominates and controls the U.S. Supreme Court. http://www.reuters.com/investigates/special-report/scotus/
"Keep quiet! Don't make waves! Do not disturb the powers that govern over us or they might take revenge and whatever you do don't go to the U.S. Supreme Court! It is controlled by lawyers who work for large self serving companies!" Check out the Reuters story at the bottom of this page.
O.K.! O.K! For the last few months I kept to a minimum my comments about global warming AND the horribly polluting Alberta Canada Tar Sands project and the XL Keystone Pipeline that will perpetuate the Oil industry for decades into the future along with the corruption within both our Canadian and U.S. federal governments. I also kept quiet about the Billions of Dollars wasted on military engagements in Iraq and Afghanistan and for what...for OIL to benefit a few top dogs in the food chain! I dare not mention the Bush family, the Koch brothers, the Chinese government's owned percentage of the Tar Sands or the Wall street Banks now back in the gambling business.
I also kept quiet about the lives lost and the soldiers wounded and maimed for life and the cost to low income tax payers war has created within both our countries. I did mourn the loss of Canada's world reputation as peace keepers and because of that I helped the N.D.P. win a local Canadian federal election but enough is enough! I will remain quiet no longer!.
In the past I used my computer ability to help a United States Senator win his election and thankfully he did some good work! He pushed through a Medicare insurance plan that has helped millions of U.S. citizens obtain medical insurance coverage and he passed Bills to stop Wall street from gambling with the life savings of average people. With a little persuasion Obama also helped a genius by the name of Elon Musk create a wonderful new machine known as the Tesla and that car is spreading around the world. It is so popular that Republican Congress leaders, backed by thir super rich friends, have reacted by slipping a dirty little Bill into the U.S. government budget that will give Wall street back the ability to once again gamble with other people's money. The first time the Banks did this the U.S. economy went down the tubes for years and thousands of people lost their homes.
Corruption continues to exist today within both our governments and the new U.S. Bill allows private investors to buy elections for hand picked local politicians. Within the U.S. government powerful Senators have promised to push through an Oil pipeline that will continue the use of fossil fuels here and around the world in spite of the fact that global warming is slowly changing the climate of our planet. Today, December 31, 2015, powerful self interest groups are winning within the U.S. government, however, they are not winning in Canada and they will lose the Tar Sands project and the XL pipeline when soon the Canadian federal Conservative government is deservedly kicked out of office. What I would like to see is Hilary Clinton win the White House and maintain and protect the laws that have protected average Americans from predatory Banks during the last few years. Gambling with life savings and pension funds is a crime and must remain a crime. I would also be over joyed if Hilary finally rid the world of fossil fuels and the dirty political influence they continue to exert on our governments. May the New Year bring you peace and a better way of life!
---------------------------------------------------------------------------------------------------
Reuters has an interesting story! It is how corporate America dominates and controls the U.S. Supreme Court. http://www.reuters.com/investigates/special-report/scotus/
Monday, December 22, 2014
Solid Proof Of Global Warming.
Gentle Readers: The following articles are from http://earthobservatory.nasa.gov/blogs/?eocn=topnav&eoci=blogs
If you want solid proof of global warming simply look at the Greenland glacier which has retreated two Kilometers or the 11 trillion gallons of water needed to stop the drought in California.
AGU 2014: The Buzz
December 16th, 2014 by Kathryn Hansen
A record 25,000 researchers and exhibitors descended on San Francisco this week for the 2014 meeting of the American Geophysical Union (AGU). That number of attendees translates to a tremendous amount of Earth science being discussed via presentations and posters, and we can’t possibly cover it all in this blog. Fortunately, this buzz word graphic posted by @AGU_Eos helped us sort what attendees are talking about, at least on twitter at #AGU14.
Drought was certainly a hot topic, particularly California’s multi-year episode. NASA scientists announced at a press briefing that it would take about 11 trillion gallons of water (42 cubic kilometers)—or 1.5 times the maximum volume of the largest U.S. reservoir—to recover from the current drought. The calculation, based on data from the Gravity Recovery and Climate Experiment (GRACE) satellites, is the first of its kind. Read the full story here.
The buzz word “ice” probably stems from the abundance of research on Greenland that was presented on December 15. Scientists using ground-based and airborne radar instruments found that liquid water can now persist throughout the year on the perimeter of the ice sheet; it might help kick off melting in the spring and summer. Read more about those studies here. Look, too, at this new study that used satellite data to get a better picture of how the ice sheet is losing mass.
And finally, take a minute to browse some of the cool photos presented by Anders Bjørk of the Natural History Museum of Denmark, which included the portrait of Arctic explorers (below) and this image pairdemonstrating glacial retreat in Greenland.
Intelligence is a wonderful thing!
Gentle Citizens of the World:
Intelligence is a wonderful thing! It allows
human beings to compete for food and territory with each other and with the other species on this planet. Also, and because of our intelligence, we survive better and more comfortably than do animals who are living in the wild and who are attempting to co-exist with us. Unfortunately because of our
intelligence, we have beaten and killed and dominated the other species into near extinction! Many species including our beautiful Lions and Elephants and Tigers are losing the struggle for basic survival while we humans proliferate into the billions. The few solutions we have
attempted to create in order to slow our human birth rate have been disallowed by our prolific religious world leaders and a majority of our world
politicians who unfortunately are not, in most part, educated in basic science. All the other species are now subject to us!
The trees and plants and microbes and germs and viruses are no exception. Humans are masters of the planet! I
am ashamed to be a human who is forced to witness the destruction
of other life forms because I am willing to share this planet and to help protect all life forms on this planet. I refuse to be pushed off this planet by polluters and pollution!
We Homo Sapiens have created tools and guns and
ways to murder each other and as many
other species as have the temerity to exist or
stand in our way! We are foolishly and ignorantly proud of our so-called
"industrial progress" and that industrial progress has been destroying
and not enhancing life on Earth. If it were the other way around I would not feel the need to write these words!
I now ask you, on behalf of the other species who cannot ask, to please create and enforce stronger
anti-pollution laws and to actively work to save the natural environment of this planet!
Please create and place economic value on
products that help nature and do not destroy nature. Please reward those humans who create life enhancing products and stop economically rewarding those who create
products that pollute and harm life on Earth! That would include guns and bombs, fossil fuels and gas burning cars
and destructive chemicals and industrial products that do us all harm! Please slow or stop the Media advertising of such destructive products!
We humans are highly intelligent and we can use our collective imaginations for creating cities filled with flower
gardens and trees and roof-top green houses. Cities filled with Bicycle
paths and Electric vehicles and quick non-polluting mass transit systems. We certainly can use our half empty
office buildings at night for creating living spaces for homeless people and for plants and even for small animals. We must ban the
internal combustion engines from our city streets and destructive fossil fuels and polluting chemicals from our lives. We do have wonderful alternatives ready for use.
We can improve our mass transit systems and we must lower Electric
Bus fares for the poor and elderly who are the ones left out and behind
when you speak about growing the middle class.
We can create buildings that allow for quiet rooms where people could go
and sit and relax without the mind disturbing incessant noise now permeating
large shopping malls.
You can even place shopping-malls under ground and place large Geodesic Domes filled with plants and trees and small animals above the shopping malls.
You can even place shopping-malls under ground and place large Geodesic Domes filled with plants and trees and small animals above the shopping malls.
You can do all of these wonderful things or you can do nothing and
watch as nature, now polluted by humans, silently turns against life on
Earth.
Thanks for reading this letter!
Joseph Raglione
Executive director: The World Humanitarian Peace
and Ecology Movement.
Sunday, December 21, 2014
The World Humanitarian Peace and Ecology Movement presents:
Our international web site index.
Freedom with honesty and justice and courage…
Compassion with dignity, tolerance and humour…
Peace with love and harmony towards all life on Earth.
All that ever was still is constantly changing within the eternal energy of the
universe and the only constant within eternity is constant change. Author: Joseph Raglione.
Gentle People:
universe and the only constant within eternity is constant change. Author: Joseph Raglione.
Gentle People:
Welcome to my index of fun web sites and return as often as you like. Joseph Raglione/
10.= http://www.Ted.com
12. = http://www.Reuters.com
17. = http://www.wwfindia.org/
18. = http://www.youtube.com/watch?v=FhLa6O1OP0Y
21. = http://storyofstuff.org/
30.= http://www.iTooch.com How to greatly improve our school systems.
49. http://eol.org/50. http://www.seedsavers.org/onlinestore/
51. http://www.human4us.net/
52. https://plus.google.com/u/0/+PopularScience/posts
Monday, December 15, 2014
Hello Gentle Readers:
I have a new web site you may like:
http://www.human4us.net/
It is filled with great pictures of beautiful flowers and they are all free to copy.
Have Fun and
Happy Holidays.
I have a new web site you may like:
http://www.human4us.net/
It is filled with great pictures of beautiful flowers and they are all free to copy.
Have Fun and
Happy Holidays.
Friday, December 12, 2014
A cure for Cancer...yes...but only for the rich!
Gentle People: If you have a million dollars you have enough to cure your incurable Cancers. What we need are generic drugs that do the same thing for a few hundred dollars. Attention you smart guys in China! Can you make the same drugs for less money? A lot less money? Recently the super star Hockey player Dave Henderson was cured of his cancer with Imbruvica. There are thousands of people waiting in line who cannot afford the current $100.000. a year price tag for this Cancer curing drug. They need your help!
Bristol-Myers Squibb, Pharmacyclics and Janssen Announce Clinical Collaboration to Evaluate OPDIVO® (nivolumab) and IMBRUVICA®(ibrutinib) in Non-Hodgkin Lymphoma
Monday, October 13, 2014 8:00 am EDT
"We look forward to working with Pharmacyclics and Janssen to evaluate the potential of these two therapies as options for patients with lymphomas."
NEW YORK & SUNNYVALE, Calif. & RARITAN, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY),Pharmacyclics, Inc. (NASDAQ:PCYC), and Janssen Research & Development, LLC announced today they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO®(nivolumab) in combination with IMBRUVICA® (ibrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL). Bristol-Myers Squibb has proposed the name OPDIVO (pronounced op-dee-voh), which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab.
OPDIVO is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies.
“Our collaboration to study OPDIVO in combination with IMBRUVICA is an innovative approach to accelerating Bristol-Myers Squibb’s progress in the study of immuno-oncology and hematologic malignancies, gaining further insight into promising areas of drug development and research,” stated Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “We look forward to working with Pharmacyclics and Janssen to evaluate the potential of these two therapies as options for patients with lymphomas.”
“We are excited about the opportunity to understand and evaluate the potential activity of IMBRUVICA and OPDIVO together, and the benefits this combination may offer patients,” said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. “We look forward to working with Bristol-Myers Squibb and Pharmacyclics on this study as we continue to grow the body of knowledge about IMBRUVICA in different settings and patient populations.”
“This collaboration underscores our interest in exploring the use of IMBRUVICA in combination with other therapies to address a variety of histologies in which we believe IMBRUVICA can make a meaningful clinical difference,” said Bob Duggan, Chairman and CEO, Pharmacyclics. “We value our strategic collaboration with Janssen and look forward to extending our relationship to Bristol-Myers Squibb for this project as our companies collectively seek to advance treatment options for patients.”
The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.
About OPDIVO (nivolumab)
Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. OPDIVO is an investigational, fully-human PD-1 (programmed death-1) immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells.
Bristol-Myers Squibb has a broad, global development program to study OPDIVO in multiple tumor types consisting of more than 35 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and NHL.
In 2013, the FDA granted Fast Track designation for OPDIVO in NSCLC, melanoma and RCC. In April 2014, the company initiated a rolling submission with the FDA for OPDIVO in third-line pre-treated squamous cell NSCLC and expects to complete the submission by year-end. The FDA granted its first Breakthrough Therapy Designation for OPDIVO in May 2014 for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab. On July 4, Ono Pharmaceutical Co. announced that OPDIVO received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma, making OPDIVO the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. On September 26, Bristol-Myers Squibb announced that the FDA accepted for priority review the Biologics License Application for previously treated advanced melanoma, and the Prescription Drug User Fee Act goal date for a decision is March 30, 2015. The FDA also granted OPDIVO Breakthrough Therapy status for this indication. In the European Union, the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for OPDIVO in advanced melanoma. The application has also been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use. The EMA also validated for review the MAA for nivolumab in NSCLC.
About IMBRUVICA®
IMBRUVICA® (ibrutinib) is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton's tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells. IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.
IMBRUVICA is approved for the treatment of patients with CLL who have received at least one prior therapy, and for the treatment of CLL patients with del 17p, a genetic mutation that occurs when part of chromosome 17 has been lost.
IMBRUVICA is also approved for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Accelerated approval was granted for the MCL indication based on overall response rate (ORR). Improvements in survival or disease-related symptoms have not been established. Continued approval for the MCL indication may be contingent upon verification of clinical benefit in confirmatory trials.
IMBRUVICA is being studied alone and in combination with other treatments in several blood cancers including CLL, MCL, Waldenström's macroglobulinemia (WM), DLBCL, FL and multiple myeloma (MM). Approximately 3,500 patients have received IMBRUVICA in clinical trials conducted in 35 countries by more than 800 investigators around the world. As of June 30, 2014, 12 Phase 3 trials have been initiated with IMBRUVICA and approximately 50 trials are registered onwww.clinicaltrials.gov. The overall clinical development program in CLL currently includes seven Phase 3 trials and covers all lines of therapy and various combinations of treatments.
IMBRUVICA was one the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway, and is the only product to have received three Breakthrough Therapy Designations. IMBRUVICA is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics.
IMBRUVICA INDICATIONS
IMBRUVICA is indicated to treat people with:
- Mantle cell lymphoma (MCL) who have received at least one prior therapy
- Accelerated approval was granted for this indication based on overall response rate. Improvements in survival or disease-related symptoms have not been established. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
- Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy
- Chronic lymphocytic leukemia (CLL) with 17p deletion
IMBRUVICA - IMPORTANT SAFETY INFORMATION
Warnings and Precautions include hemorrhage, infection, cyptopenias, atrial fibrillation, second primary malignancies, and embryo-fetal toxicity.
The most common adverse reactions include thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, peripheral edema, upper respiratory tract infection, nausea, bruising, dyspnea, constipation, rash, abdominal pain, pyrexia, vomiting, and decreased appetite.
For additional important safety information, please see Full Prescribing Information at www.imbruvica.com/isi/.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
About Pharmacyclics
Pharmacyclics, Inc. (NASDAQ: PCYC) is a biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune-mediated diseases. The Company's mission and goal is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical healthcare needs; and to identify and control promising product candidates based on scientific development and administrational expertise, develop its products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.
Pharmacyclics markets IMBRUVICA® (ibrutinib) and has three product candidates in clinical development and several preclinical molecules in lead optimization. The Company is committed to high standards of ethics, scientific rigor, and operational efficiency as it moves each of these programs to viable commercialization. Pharmacyclics is headquartered in Sunnyvale, CA. Please visit http://www.pharmacyclics.com.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development is part of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ). Please visit www.janssenrnd.com for more information.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that nivolumab will receive regulatory approval in the U.S. either as a single agent or in a combination regimen, or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Pharmacyclics Safe Harbor Statement
This announcement may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements, among others, relating to our future capital requirements, including our expected liquidity position and timing of the receipt of certain milestone payments, and the sufficiency of our current assets to meet these requirements, our future results of operations, our expectations for and timing of ongoing or future clinical trials and regulatory approvals for any of our product candidates, and our plans, objectives, expectations and intentions. Because these statements apply to future events, they are subject to risks and uncertainties. When used in this announcement, the words "anticipate", "believe", "estimate", "expect", "expectation", "goal", "should", "would", "project", "plan", "predict", "intend", "target" and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to us and are subject to a number of risks, uncertainties and other factors that could cause our actual results, performance, expected liquidity or achievements to differ materially from those projected in, or implied by, these forward-looking statements. Factors that may cause such a difference include, without limitation, our need for substantial additional financing and the availability and terms of any such financing, the safety and/or efficacy results of clinical trials of our product candidates, our failure to obtain regulatory approvals or comply with ongoing governmental regulation, our ability to commercialize, manufacture and achieve market acceptance of any of our product candidates, for which we rely heavily on collaboration with third parties, and our ability to protect and enforce our intellectual property rights and to operate without infringing upon the proprietary rights of third parties. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance or achievements and no assurance can be given that the actual results will be consistent with these forward-looking statements. For more information about the risks and uncertainties that may affect our results, please see the Risk Factors section of our filings with the Securities and Exchange Commission, including our Form 10-K for the year ended December 31, 2013 and quarterly reports on Form 10-Q. We do not intend to update any of the forward-looking statements after the date of this announcement to conform these statements to actual results, to changes in management's expectations or otherwise, except as may be required by law.
Johnson & Johnson Note on Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in new product development, including obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to regulations and domestic and foreign health care reforms; and general industry conditions, including trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
IMBRUVICA is a registered trademark of Pharmacyclics, Inc.
Contact:
Bristol-Myers Squibb
Media:
Ken Dominski, 609-252-5251
ken.dominski@bms.com
or
Investors:
Ranya Dajani, 609-252-5330
ranya.dajani@bms.com
or
Ryan Asay, 609-252-5020
ryan.asay@bms.com
or
Pharmacyclics
Media:
Samina Bari, 408-215-3169
or
Investors:
Ramses Erdtmann, 408-215-3325
or
IMBRUVICA Medical Information:
Pharmacyclics Medical Information: 877-877-3536
or
Janssen
Media:
Kellie McLaughlin, 908-927-7477
Mobile: 609-468-8356
or
Investors:
Stan Panasewicz, 732-524-2524
or
Louise Mehrotra, 732-524-6491
Media:
Ken Dominski, 609-252-5251
ken.dominski@bms.com
or
Investors:
Ranya Dajani, 609-252-5330
ranya.dajani@bms.com
or
Ryan Asay, 609-252-5020
ryan.asay@bms.com
or
Pharmacyclics
Media:
Samina Bari, 408-215-3169
or
Investors:
Ramses Erdtmann, 408-215-3325
or
IMBRUVICA Medical Information:
Pharmacyclics Medical Information: 877-877-3536
or
Janssen
Media:
Kellie McLaughlin, 908-927-7477
Mobile: 609-468-8356
or
Investors:
Stan Panasewicz, 732-524-2524
or
Louise Mehrotra, 732-524-6491
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