Friday, May 24 2013 11:47 PM EDT2013-05-25 03:47:15 GMT
The Indiana Pacers are trying to even the Eastern Conference finals in Miami. Indiana has opened up a 12-point lead late in the first quarter. Roy Hibbert leads the Pacers with eight points. LeBron JamesMore >>
The Indiana Pacers have evened the Eastern Conference finals in Miami.More >>
Friday, May 24 2013 11:18 PM EDT2013-05-25 03:18:05 GMT
Several Indiana teachers put their lives on the line just a year ago when two F-4 tornadoes hit Henryville and destroyed the elementary and high school. When Henryville Elementary School Teacher KristiMore >>
Several Indiana teachers put their lives on the line just a year ago when two F-4 tornadoes hit Henryville and destroyed the elementary and high school.More >>
Friday, May 24 2013 11:03 PM EDT2013-05-25 03:03:19 GMT
A female pedestrian is in the hospital after being struck by a vehicle on the northeast side of Indianapolis. The woman was hit on E. 34th Street, between Gladstone and Colorado, around 9:45 p.m. Friday.More >>
A female pedestrian is in the hospital after being struck by a vehicle on the northeast side of Indianapolis.More >>
Friday, May 24 2013 10:41 PM EDT2013-05-25 02:41:45 GMT
A couple from Elwood face charges after police say they found a marijuana growing operation in their basement. Stephen Stookey, 70, and Marilyn Stookey, 69, were arrested after police raided their homeMore >>
A couple from Elwood face charges after police say they found a marijuana growing operation in their basement.More >>
Friday, May 24 2013 10:04 PM EDT2013-05-25 02:04:40 GMT
Two people are in custody after an incident where an IMPD officer fired his duty weapon. Police say officers were investigating an incident in the 3200 block of Boulevard Place when a suspect failed toMore >>
Two people are in custody after an incident where an IMPD officer fired his duty weapon.More >>
Friday, May 24 2013 9:59 PM EDT2013-05-25 01:59:31 GMT
Indiana University President Michael McRobbie is recommending tuition and fee increases of 1.75 percent for Indiana residents in each of the next two years at the school's Bloomington campus. The universityMore >>
Indiana University President Michael McRobbie is recommending tuition and fee increases of 1.75 percent for Indiana residents in each of the next two years at the school's Bloomington campus.More >>
Friday, May 24 2013 7:55 PM EDT2013-05-24 23:55:55 GMT
A Greenfield police officer is fighting to keep his vanity license plate. Rodney Vawter has owned the personalized Fraternal Order of Police license plate "0INK" for the past three years. A class actionMore >>
A Greenfield police officer is fighting to keep his vanity license plate after it was revoked by the BMV.More >>
Friday, May 24 2013 6:44 PM EDT2013-05-24 22:44:52 GMT
Andretti Autosport has five cars in the top nine in Sunday's Indianapolis 500. Any of them could win the race. The team has already won three out of four INDYCAR races this season. One of the AndrettiMore >>
I'm picking Marco to finally add another win to the Andretti legacy at Indianapolis.More >>
Friday, May 24 2013 6:32 PM EDT2013-05-24 22:32:12 GMT
One of our city's best-known landmarks could soon see some changes not just in the way it looks, but in the way it's used. Friday's Memorial Day service is one of many events that takes place on MonumentMore >>
One of our city's best-known landmarks could soon see some changes not just in the way it looks, but in the way it's used.More >>
Friday, May 24 2013 5:58 PM EDT2013-05-24 21:58:56 GMT
East side residents are questioning the safety of a crosswalk where a pedestrian was killed by an IMPD cruiser Thursday night. Richard Allen Moore died after he was struck by IMPD Ofc. Jason Rauch atMore >>
East side residents are questioning the safety of a crosswalk where a pedestrian was killed by an IMPD cruiser Thursday night.More >>
Information contained on this page is provided by companies via press release distributed through PR Newswire, an independent third-party content provider. PR Newswire, WorldNow and this Station make no warranties or representations in connection therewith.
SOURCE Takeda Pharmaceutical Company Limited
OSAKA, Japan, March 7, 2013 /PRNewswire/ --
Takeda Pharmaceutical Company Limited ("Takeda") today announced that a Marketing Authorisation Application (MAA) has been submitted to The European Medicines Agency (EMA) for vedolizumab, an investigational, gut-selective humanized monoclonal antibody for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD), the two most common types of inflammatory bowel disease (IBD). If approved, vedolizumab would be the first and only gut-selective biologic agent for UC and CD on the market.
"Ulcerative colitis and Crohn's disease are chronic debilitating diseases with important unmet medical needs, often affecting young people in the prime of their lives," said Asit Parikh, M.D., Ph.D., vice president, general medicine, Takeda. "We are encouraged by the findings of GEMINI, the vedolizumab Phase 3 clinical development program, which studied approximately 3,000 patients in nearly 40 countries, making it the largest IBD clinical trial program conducted to date."
Nearly four million people worldwide are affected by IBD, with UC affecting more than 500,000 people and CD affecting approximately 230,000 people in the EU.Crohn's disease and ulcerative colitis are chronic diseases that cause inflammation of the lining of the digestive tract. Inflammation caused by CD can involve varying areas of the digestive tract, while UC impacts the colon only.CD and UC can be both painful and debilitating, which may sometimes lead to serious complications and can significantly impact the quality of life for patients.
The MAA submission was supported by Phase 3 clinical studies, GEMINI I, GEMINI II, GEMINI III and GEMINI LTS (Long-term Safety), which are part of the GEMINI Studies™, a four-study clinical research program to investigate the efficacy and safety of vedolizumab on clinical response and remission in moderately to severely active CD and UC patients, who had failed at least one conventional or anti-TNFa therapy.
"With a targeted mechanism of action, vedolizumab has clinical promise as a potential treatment option for people with moderate to severely active CD and UC," said Paul Rutgeerts, M.D., Ph.D., F.R.C.P., professor of medicine, Catholic University of Leuven, Belgium. "While there is no known cure, there is a need for new CD and UC treatment options, in an effort to provide patients with additional choices for managing their disease, reducing symptoms and achieving remission."
About Crohn's disease and ulcerative colitis
Crohn's disease (CD) and ulcerative colitis (UC) are the two most common forms of inflammatory bowel disease (IBD), which is marked by inflammation in the lining of the GI tract. CD can impact any part of the digestive tract, and common symptoms may include abdominal pain, diarrhea, rectal bleeding, weight loss, and/or fever. UC impacts the large intestine only, which includes the colon and the rectum. The most common symptoms of UC include abdominal discomfort and blood or pus in diarrhea. There is no known cause for CD or UC, although many researchers believe that the interaction of an outside agent, such as a virus or bacteria, with the body's immune system may trigger them. No cure exists for CD or UC; the aim of IBD treatments is to induce and maintain remission, or achieve extended periods of time when patients do not experience symptoms.
Vedolizumab was developed for the treatment of CD and UC, as a gut-selective, humanized monoclonal antibody that specifically antagonizes the alpha4beta7 (a4ß7) integrin, which is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in CD and UC. a4ß7 binds with a specific adhesion molecule primarily expressed in the intestinal tract. Therefore, vedolizumab, by preventing this interaction, has a gut selective effect.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, http://www.takeda.com.
This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.
The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.
Friday, May 24 2013 11:46 AM EDT2013-05-24 15:46:25 GMT
A woman faces sentencing Friday for her part in the shooting death of a female basketball star. The shooting happened last July at Ben Davis Park on the city's west side. Witnesses say Vincennes UniversityMore >>
A woman faces sentencing Friday for her part in the shooting death of a female basketball star.More >>
Friday, May 24 2013 11:19 AM EDT2013-05-24 15:19:14 GMT
Police are seeking criminal charges against two missing campers who were found on the Indiana National Guard's Camp Atterbury. Bartholomew County sheriff's Maj. Todd Noblitt says the two men, ages 19More >>
Bartholomew County sheriff's Maj. Todd Noblitt says the two men, ages 19 and 20, were found Wednesday after a ground and air search for several hours by police officers and soldiers of the Atterbury grounds near Edinburgh.More >>
Friday, May 24 2013 5:02 PM EDT2013-05-24 21:02:40 GMT
A pedestrian was seriously hurt after being struck by a police officer on the east side of Indianapolis. The accident happened around 9:30 p.m. Thursday near the intersection of 42nd Street and EmersonMore >>
The family of Richard Allen Moore told Eyewitness News that he was killed in the accident.More >>
Friday, May 24 2013 11:29 AM EDT2013-05-24 15:29:00 GMT
Authorities say a cat might have started a central Indiana house fire by knocking over a lamp. The fire happened Thursday in the town of Chesterfield just east of Anderson. Chesterfield deputy fire chiefMore >>
Authorities say a cat might have started a central Indiana house fire by knocking over a lamp.More >>
Friday, May 24 2013 11:22 AM EDT2013-05-24 15:22:46 GMT
It will likely be months before a judge rules on whether a new trial should be granted to a man convicted of killing an Indiana University student who disappeared during a 2000 bike ride. A Morgan CountyMore >>
It will likely be months before a judge rules on whether a new trial should be granted to a man convicted of killing an Indiana University student who disappeared during a 2000 bike ride.More >>
Thursday, May 23 2013 4:20 PM EDT2013-05-23 20:20:10 GMT
One of Indiana's largest health systems says it's cutting an undisclosed number of jobs by June 30 because of increasing economic and competitive pressure on the health care industry. Indianapolis-basedMore >>
One of Indiana's largest health systems says it's cutting an undisclosed number of jobs by June 30 because of increasing economic and competitive pressure on the health care industry.More >>
Friday, May 24 2013 3:37 PM EDT2013-05-24 19:37:35 GMT
An act of credit card fraud has been traced back to a downtown Indianapolis restaurant. Some workers upstairs love walking downstairs for a bite at Ike and Jonesy's downtown. But they say the bite isMore >>
The owner of Ike & Jonesy's downtown says he is working to find out how the credit and debit cards of several customers and employees could have been compromised.More >>
Friday, May 24 2013 10:26 AM EDT2013-05-24 14:26:01 GMT
Officials with the Indianapolis Motor Speedway tell Eyewitness News that 35 runners from the Midwest who did not complete the Boston Marathon because of the tragedy there will be finishing that race atMore >>
The Speedway invited runners to cross the finish line on race day morning before the start of the race. They will be running from Turn Four across the historic Yard of Bricks.More >>