Saturday, May 30, 2015

Messages#2

 

Hastert Case Is Said to Be Linked to Decades-Old Sexual Abuse - New York Times

http://news.google.com Sat, 30 May 2015 01:27:03 GMT

Post-BulletinHastert Case Is Said to Be Linked to Decades-Old Sexual AbuseNew York TimesIn Mr. Hastert's 2004 memoir, “Speaker: Lessons From Forty Years in Coaching and Politics,” Mr. Hastert acknowledged the wrestling squad of 1976, a championship t ...

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Obama Warns the Senate to Pass Surveillance Law - New York Times

http://news.google.com Sat, 30 May 2015 01:14:06 GMT

New York TimesObama Warns the Senate to Pass Surveillance LawNew York TimesWASHINGTON — President Obama suggested ominously on Friday that allowing domestic surveillance programs to expire at a Sunday deadline could lead to a terrorist attack on the ...

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Poroshenko to personally introduce Saakashvili as Odesa region governor on ... - Ukraine Today

http://news.google.com Sat, 30 May 2015 08:07:21 GMT

Ukraine TodayPoroshenko to personally introduce Saakashvili as Odesa region governor on ...Ukraine TodayThis became known on Friday evening, Odesa Regional Administration Press Secretary Mykola Pokrovsky told UNIAN. Other sources say, the new governo ...

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An Award for Bill Clinton Came With $500000 for His Foundation - New York Times

http://news.google.com Fri, 29 May 2015 17:46:24 GMT

New York TimesAn Award for Bill Clinton Came With $500000 for His FoundationNew York TimesTo commemorate the 10th anniversary of the 2004 Indian Ocean tsunami, Petra Nemcova, a Czech model who survived the disaster by clinging to a palm tree, decided ...

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Joining Swim Across America on May 30? If not, you have a year to train - Tampabay.com

http://news.google.com Thu, 28 May 2015 21:12:07 GMT

Tampabay.comJoining Swim Across America on May 30? If not, you have a year to trainTampabay.comSince the first open-water event off Nantucket Island in 1987, Swim Across America, which comes to Clearwater Beach on May 30, has raised more than $55 mil ...

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Free Skin Cancer Screening Offered May 30 - University of Rochester Newsroom

http://news.google.com Tue, 12 May 2015 15:20:41 GMT

University of Rochester NewsroomFree Skin Cancer Screening Offered May 30University of Rochester NewsroomUR Medicine's Department of Dermatology is joining forces with the American Academy of Dermatology and the Rochester Dermatologic Society to prov ...

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Lemon weekend May 30-31 - KARE

http://news.google.com Sat, 23 May 2015 06:52:57 GMT

KARELemon weekend May 30-31KAREGOLDEN VALLEY, Minn. -- The annual lemon weekend for Alex's Lemonade Stand raises funds for childhood cancer research. Cancer survivor Molly Hollway and the lemon girls stopped by KARE 11 Saturday with details. The Lemo ...

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Thursday, May 28, 2015

Messages #1

  

 

NY socialite Gigi Jordan gets 15 years for killing autistic 8-year-old son - CBS News

Thu, 28 May 2015 20:40:50 GMT

CBS NewsNY socialite Gigi Jordan gets 15 years for killing autistic 8-year-old sonCBS NewsNEW YORK -- Gigi Jordan, a former pharmaceuticals executive and socialite convicted in the death of her autistic 8-year-old son, was sentenced Thursday to 18 ye ...

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Assembly passes universal health care bill - Capital New York

Thu, 28 May 2015 10:21:53 GMT

Capital New YorkAssembly passes universal health care billCapital New YorkAssemblyman Richard Gottfried, chair of the health committee, gave an impassioned speech on the floor in support of the New York Health Act, arguing that it was long past time ...

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Banker jumps to his death from luxury apartment - New York Post

Thu, 28 May 2015 23:44:20 GMT

New York PostBanker jumps to his death from luxury apartmentNew York PostHe owned an apartment in the posh, 36-story Ocean complex, which overlooks Battery Park and New York Harbor, and had just returned from a vacation in the Bahamas, sources said. ...

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How to get a free lunch and a new job - CNNMoney

Thu, 28 May 2015 18:27:58 GMT

CNNMoneyHow to get a free lunch and a new jobCNNMoneyYou're going to have lunch anyway. Why not have it with someone who might want to give you a job? That's the idea behind Lunchcruit, a startup that matches job seekers with hiring managers for zero ...

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Teens: How to find a summer job - 9NEWS.com

Thu, 28 May 2015 22:10:32 GMT

Teens: How to find a summer job9NEWS.comIn April, Colorado added 4,200 jobs, and this year, there are more job opportunities for teens than in years past. 'This summer is probably going to be the best summer we've had in seven or so years. We saw the ...

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JPMorgan Said to Plan Thousands of Job Cuts as Bank Pares Costs - Bloomberg

Thu, 28 May 2015 20:28:03 GMT

BloombergJPMorgan Said to Plan Thousands of Job Cuts as Bank Pares CostsBloombergJPMorgan Chase & Co. will cut thousands of jobs over the next year as the biggest U.S. bank by assets seeks to contain expenses and sells businesses, said a person with ...

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Class of 2015 Is Summa Cum Lucky in the Job Market - Wall Street Journal

Fri, 29 May 2015 02:30:43 GMT

Wall Street JournalClass of 2015 Is Summa Cum Lucky in the Job MarketWall Street JournalAdam Quade worried his younger sister would have the same trouble he had landing a job after college. He started looking his senior year and by graduation in 2010 ...

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Monday, May 25, 2015

Building Secure Futures, One Family at a Time


At every stage of life, life insurance is an important consideration for protecting your family and your assets. As much as you may not want to think about it, you cannot afford to avoid making these important preparations. Life insurance can be vital to helping your loved ones maintain their standard of living after your death. If you have dependents — a spouse, domestic partner, children and/or an aging parent — you should ensure that your retirement pension and savings are sufficient to secure their future.
Many Americans think that they can't afford life insurance, especially when some are struggling to balance the daily and monthly expenses that most households face. But life insurance is often more affordable than you might think. In fact, more than 80 percent of Americans overestimate the cost of life insurance. Most people who are uninsured believe that a 20-year, $250,000 term life policy for a healthy 30-year-old would cost $400 per year. But the real cost would actually be only a quarter of that, or about the same cost as your Netflix subscription each month.
Types of Life Insurance
If you're unsure about life insurance, you're not alone. Many individuals are confused about how life insurance works. According to LIMRA, 70 percent of Americans failed a 10 question basic life insurance IQ test.
The truth is not all life insurance plans are created equally. In fact, there is a whole host of different types of life insurance to fit your budget, lifestyle and needs.
One of the most common types is term life insurance, which offers affordable coverage for a specific number of years and is great if you want to provide coverage while you pay off certain debts or until you've fulfilled some anticipated responsibilities, such as until your children are out of college. However, while term life insurance is an affordable way to get maximum coverage, it also increases in cost after the specified period, so it may not be cost effective in the long run.
On the other hand, permanent life insurance policies are ones that do not expire. They protect your loved ones permanently. These plans typically offer more long-term security and may even accumulate cash value over time. While permanent life insurance may initially cost more than term life insurance, they can also be more cost-effective in the long term.
Depending on your responsibilities and financial situation, the best life insurance plan for you may be term insurance, permanent or one of the many other options offered by insurance companies.
Helping You Find Insurance
Many leading insurance companies are making it easier than ever to put life insurance within reach. And some companies have new products for Americans who otherwise might not have easy access to life insurance plans.
Life insurance can also provide an array of benefits to dependents such as:
1. Assistance in paying off debts such as a mortgage, auto loan or credit card
2. Coverage of daily living expenses
3. Help with saving for expenses such as college tuition, weddings or starting a business
4. Paying for funeral expenses
In addition to expanding their coverage to include families who may traditionally be underinsured, major life insurance companies have also worked to develop tools, such as insurance premium calculators, that help you select the type of life insurance that is right for your needs and concerns.
Many companies have commissioned studies that explore the changing demographics, retirement ages, lifestyle habits and compositions of American households and have developed adaptable insurance policies in response. Other insurers have taken steps to diversify their offerings to better fit the needs of customers in developing nations.
MetLife, for example, has developed insurance plans to target traditionally uninsured customers in the United States and abroad. The New York-based insurer now offers prepaid insurance policies at Walmart stores in Georgia and South Carolina, with a first month's premium of just $5. The company has also developed initiatives to increase access to insurance in the Bogota region of Colombia by selling policies through supermarkets, door-to-door and allowing customers to pay their insurance premiums through their natural gas utility bill.
It may seem complicated and you may not want to think about it while you're in the prime of your life, but life insurance is easier to obtain and less expensive than you might think. There are several helpful tools and information available to help you find sufficient means to provide security for your families and loved ones. Picking life insurance shouldn't be a burden but an easy process. You should be able to enjoy the aging process and eliminate the unknown when it comes to life insurance.
About Family Features Editorial SyndicateThis and other food and lifestyle content can be found at http://www.editors.familyfeatures.com. Family Features is a leading provider of free food and lifestyle content for use in print and online publications. Register with no obligation to access a variety of formatted and unformatted features, accompanying photos, and automatically updating Web content solutions.

SOURCE Family Features Editorial Syndicate


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Saturday, May 23, 2015

Harlem Globetrotters Legend Marques Haynes Passes Away At 89

PHOENIX, May 22, 2015  -- Legendary Harlem Globetrotter Marques Haynes – considered by many to be the greatest basketball dribbler of all-time – http://fguzzardi.blogspot.com ied of natural causes at 4:35 this morning in Plano, Texas, at the age of 89. He passed away peacefully with family and friends in his presence. Services are pending.
In a four-decade career, Haynes played in more than 12,000 games, traveled more than four million miles and entertained fans in nearly 100 countries during two stints with the Globetrotters (1947-53, 1972-79). His dribbling style would confuse and confound opponents and became one of the Globetrotters' most potent offensive weapons.
"The game of basketball has lost one of its most iconic figures," said Globetrotters CEO Kurt Schneider. "Marques was a pioneer, helping pave the way for people of all races to have opportunities to play basketball and for the sport to explode on a global scale. His unique and groundbreaking style of play set the tone for modern basketball as we know it; anyone involved with basketball worldwide is indebted to Marques. He was the consummate Globetrotter.
"We will be dedicating our upcoming 90th anniversary tour in 2016 to Marques, and the team will wear a commemorative patch on our uniforms to salute the significant contributions he made to basketball and the Globetrotters," said Schneider.   
The acrobatic Haynes caught the attention of Harlem Globetrotters owner Abe Saperstein in 1946, during a game in which Langston defeated the Globetrotters, 74-70.  Following graduation, Haynes joined the Globetrotters and starred for the team when it defeated the George Mikan-led Minneapolis Lakers in 1948 (61-59) and in 1949 (49-45). 
In 1998, Haynes became the first player ever to be inducted into the Naismith Memorial Basketball Hall of Fame as a Globetrotter. He has been enshrined into a total of six Halls of Fame, including NAIA (1985), Jim Thorpe (1993) and Langston University (1995). On Dec. 8, 2007, Langston University honored Haynes by dedicating its basketball court as "Marques Haynes Court."
Haynes received a Globetrotters "Legends" Ring and had his jersey (#20) retired as part of a 75th Anniversary black tie charity fund-raiser on Jan. 5, 2001, at Chicago's Fairmont Hotel. Only five Globetrotters jersey numbers have been retired in the team's storied history.
Haynes' basketball career began at Booker T. Washington High School in his hometown of Sand Springs, Okla., where he led the school to a high school national championship in 1941 and was named a Second Team Scholastic All-America that season. Haynes then starred collegiately at Langston University in Langston, Okla. (1942-46), where he was a four-time All-Conference selection and team MVP. Haynes led Langston in scoring all four years and guided the team to a 112-3 record, a mark that included a 59-game winning streak.
 
Sponsored by World Vision, Greyhound Lines and Baden Sports, The Harlem Globetrotters® are celebrating their 89th consecutive year, continuing a world famous tradition of ball handling wizardry, basketball artistry, and one-of-a-kind family entertainment that continues to thrill fans of all ages. Harlem Globetrotters International, Inc. is a wholly-owned subsidiary of Herschend Family Entertainment Corporation, the largest family-owned themed entertainment company in the U.S. Throughout their history, the Original Harlem Globetrotters have showcased their iconic talents in 122 countries and territories on six continents, often breaking down cultural and societal barriers while providing fans with their first-ever basketball experience. Proud inductees of the Naismith Memorial Basketball Hall of Fame, the Globetrotters have entertained hundreds of millions of fans-among them popes, kings, queens, and presidents-over more than eight thrilling decades. For the latest news and information about the Harlem Globetrotters, and to purchase tickets and team merchandise, visit the Globetrotters' official Web site: www.harlemglobetrotters.com.

 

SOURCE Harlem Globetrotters

Monday, May 18, 2015

New Data on Several Oncology Compounds at ASCO 2015

WOODCLIFF LAKE, N.J., May 14, 2015 -- Eisai Inc. announced today the presentation of seven abstracts at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) highlighting the breadth of the company's oncology portfolio. The meeting will be held May 29-June 2 in Chicago.
"We are excited by our data at this year's ASCO Annual Meeting, which exemplify the strength and diversity of Eisai's oncology portfolio and our ongoing dedication to providing potential treatment options to underserved patient populations," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai Inc. "In support of our human health care (hhc) mission, we remain committed to the development of compounds that have the potential to positively affect the lives of patients with cancer and thereby their loved ones."
Of note, the results of a Phase 3 study of eribulin mesylate for investigational use in advanced soft tissue sarcoma (STS) will be included in the ASCO press conference on Saturday, May 30. The data will also be presented in an oral session on June 1.
In addition, the results of a Phase 2 study of lenvatinib for investigational use in metastatic renal cell carcinoma will be presented in an oral session on June 1.
Additional presentations will include ongoing analyses of the Phase 3 trial evaluating lenvatinib, a receptor tyrosine kinase (RTK) inhibitor, in radioactive iodine-refractory differentiated thyroid cancer; palonosetron in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric patients; and NEPA, an oral fixed combination of netupitant and palonosetron, in the prevention of CINV in patients receiving carboplatin chemotherapy.
The following abstracts are accepted for presentation at this year's ASCO meeting:
Abstract Name
Session
Eribulin Mesylate Abstracts
Randomized, open-label, multicenter, phase 3 study of eribulin versus dacarbazine in patients (pts) with leiomyosarcoma (LMS) and adipocytic sarcoma (ADI)
Abstract #LBA10502
Oral presentation
Monday, June 1
Oral: 3:48 p.m. - 4:00 p.m. CT
Schöffski P.
Lenvatinib Abstracts
Randomized phase II three-arm trial of lenvatinib (LEN), everolimus (EVE), and LEN+EVE in patients (pts) with metastatic renal cell carcinoma (mRCC)
Abstract #4506
Oral presentation
Monday, June 1
Oral: 11:45 a.m. - 11:57 a.m. CT
Motzer R.
Effect of age and lenvatinib treatment on overall survival for patients with 131I-refractory differentiated thyroid cancer in SELECT
Abstract #6048
Poster presentation
Saturday, May 30
Poster: 1:15 p.m. - 4:45 p.m. CT
Brose M.
Pharmacodynamic biomarkers of outcomes in the phase 3 study of lenvatinib in 131I-refractory differentiated thyroid cancer (SELECT)
Abstract #6014
Poster presentation
Saturday, May 30
Poster: 1:15 p.m. - 4:45 p.m. CT
Panel Discussion: 4:45 p.m. - 6:00 p.m. CT
Tahara M.
Efficacy and safety of lenvatinib for the treatment of patients with 131I-refractory differentiated thyroid cancer with and without prior VEGF-targeted therapy
Abstract #6013
Poster presentation
Saturday, May 30
Poster: 1:15 p.m. - 4:45 p.m. CT
Panel Discussion: 4:45 p.m. - 6:00 p.m. CT
Newbold K.
NEPA Abstracts
Should all antiemetic guidelines recommend adding a NK1 receptor antagonist (NK1RA) in patients (pts) receiving carboplatin (carbo): Efficacy evaluation of NEPA, a fixed combination of the NK1RA, netupitant, and palonosetron
Abstract #9597
Poster presentation
Saturday, May 30
Poster: 1:15 p.m. - 4:45 p.m. CT
Jordan K.
Palonosetron Abstracts
Palonosetron vs ondansetron: Prevention of chemotherapy-induced nausea and vomiting in pediatric patients in a multicycle study
Abstract #10077
Poster presentation
Sunday, May 31
Poster: 8:00 a.m. - 11:30 a.m. CT
Kabickova E.
The information discussed in this release presents investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any of these investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
About Lenvatinib (Available as LENVIMA™)Lenvatinib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
Lenvatinib, discovered and developed by Eisai, is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. Lenvatinib was approved under Priority Review designation for locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer by the FDA in February 2015. Eisai was granted Orphan Drug Designation (ODD) for lenvatinib in various types of thyroid cancer in the United States, Japan, and Europe.
Important Safety Information
Warnings and Precautions
Hypertension was reported in 73% of lenvatinib-treated patients (of which 44% were ≥ Grade 3) and 16% of patients in the placebo group. Control blood pressure prior to treatment and monitor blood pressure after 1 week, then every 2 weeks for the first 2 months, and then at least monthly during treatment.  Withhold lenvatinib for Grade 3 hypertension; resume at a reduced dose when hypertension is controlled at ≤ Grade 2. Discontinue lenvatinib for life-threatening hypertension.
Cardiac dysfunction was reported in 7% of lenvatinib-treated patients (2% Grade 3 or greater). Monitor patients for clinical symptoms or signs of cardiac decompensation. Withhold lenvatinib for development of Grade 3 cardiac dysfunction until improved to Grade 0 or 1 or baseline. Resume at a reduced dose or discontinue lenvatinib depending on the severity and persistence of cardiac dysfunction. Discontinue lenvatinib for Grade 4 cardiac dysfunction.
Arterial thromboembolic events were reported in 5% of lenvatinib-treated patients; events of Grade 3 or greater were 3%. Discontinue lenvatinib following an arterial thrombotic event. Lenvatinib has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months.
4% of lenvatinib-treated patients experienced an increase in ALT and 5% experienced an increase in AST that was Grade 3 or greater. Monitor liver function before initiation and during treatment with lenvatinib. Withhold lenvatinib for the development of ≥ Grade 3 liver impairment until resolved to Grade 0 to 1 or baseline. Resume at a reduced dose or discontinue lenvatinib depending on the severity and persistence of hepatotoxicity. Discontinue lenvatinib for hepatic failure.
Proteinuria was reported in 34% of lenvatinib-treated patients (of which 11% were Grade 3). Monitor for proteinuria before initiation of, and periodically during treatment. Obtain a 24 hour urine protein if urine dipstick proteinuria ≥2+ is detected. Withhold lenvatinib for ≥ 2 grams of proteinuria/24 hours and resume at a reduced dose when proteinuria is <2 gm/24 hours. Discontinue lenvatinib for nephrotic syndrome.
Events of renal impairment were reported in 14% of lenvatinib-treated patients. Renal failure or impairment ≥ Grade 3 was 3% in lenvatinib-treated patients. Withhold lenvatinib for development of Grade 3 or 4 renal failure/impairment until resolved to Grade 0 to 1 or baseline. Resume at a reduced dose or discontinue lenvatinib depending on the severity and persistence of renal impairment. 
Events of gastrointestinal perforation or fistula were reported in 2% of lenvatinib-treated patients.  Discontinue lenvatinib in patients who develop gastrointestinal perforation or life-threatening fistula.
QT/QTc interval prolongation was reported in 9% of lenvatinib-treated patients (2% Grade 3 or greater).  Monitor ECG in patients with congenital long QT syndrome, CHF, bradyarrhythmias, or patients taking drugs known to prolong the QT interval. Monitor and correct electrolyte abnormalities in all patients.  Withhold lenvatinib for the development of ≥ Grade 3 QT interval prolongation. Resume lenvatinib at a reduced dose when QT prolongation resolves to Grade 0 or 1 or baseline.
Hypocalcemia ≥ Grade 3 was reported in 9% of lenvatinib-treated patients. Monitor blood calcium levels at least monthly and replace calcium as necessary during lenvatinib treatment. Interrupt and adjust lenvatinib dosing as necessary depending on severity, presence of ECG changes, and persistence of hypocalcemia.
Reversible posterior leukoencephalopathy syndrome (RPLS) was reported in 3 patients across clinical studies in which 1108 patients received lenvatinib. Confirm the diagnosis of RPLS with MRI. Withhold lenvatinib for RPLS until fully resolved. Resume at a reduced dose or discontinue lenvatinib depending on the severity and persistence of neurologic symptoms.
Hemorrhagic events occurred in 35% of lenvatinib-treated patients and in 18% of the placebo group.  The incidence of Grade 3-5 hemorrhage was similar between arms at 2% and 3%, respectively. The most frequently reported hemorrhagic event was epistaxis (11% Grade 1 and 1% Grade 2). Discontinuation due to hemorrhagic events occurred in 1% of lenvatinib-treated patients. There was one case of fatal intracranial hemorrhage among 16 patients who received lenvatinib and had CNS metastases at baseline. Withhold lenvatinib for the development of Grade 3 hemorrhage until resolved to Grade 0 to 1.  Resume at a reduced dose or discontinue lenvatinib depending on the severity and persistence of hemorrhage. Discontinue lenvatinib in patients who experience Grade 4 hemorrhage.
Lenvatinib impairs exogenous thyroid suppression. Elevation of TSH level above 0.5 mU/L was observed post baseline in 57% of lenvatinib-treated patients. Monitor TSH levels monthly and adjust thyroid replacement medication as needed.
Lenvatinib can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with lenvatinib and for at least 2 weeks following completion of therapy.
Advise women not to breastfeed during treatment with lenvatinib.
Adverse Reactions
The most common adverse reactions observed in lenvatinib-treated patients vs. placebo-treated patients respectively were hypertension (73% vs 16%), fatigue (67% vs 35%), diarrhea (67% vs 17%), arthralgia/myalgia (62% vs 28%), decreased appetite (54% vs 18%), weight decreased (51% vs 15%), nausea (47% vs 25%), stomatitis (41% vs 8%), headache (38% vs 11%), vomiting (36% vs 15%), proteinuria (34% vs 3%), palmar-plantar erythrodysesthesia syndrome (32% vs 1%), abdominal pain (31% vs 11%), and dysphonia (31% vs 5%).
For more information about lenvatinib, click here for the full Prescribing Information.
About Eribulin Mesylate Injection (available as Halaven®)
Eribulin is indicated for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic breast cancer. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First in the halichondrin class, eribulin is a microtubule dynamics inhibitor with a distinct binding profile. Based on in vitro studies, eribulin exerts its effect via a tubulin-based antimitotic mechanism ultimately leading to apoptotic cell death after prolonged and irreversible mitotic blockage.
Important Safety Information
Neutropenia
  • Monitor complete blood counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days
  • Severe neutropenia (ANC <500/mm3) lasting more than 1 week occurred in 12% (62/503) of patients. Patients with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels
  • Grade 3 and Grade 4 neutropenia occurred in 28% and 29%, respectively, of patients who received eribulin. Febrile neutropenia occurred in 5% of patients and two patients (0.4%) died from complications
Peripheral Neuropathy
  • Patients should be monitored closely for signs of peripheral motor and sensory neuropathy
  • Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4% of patients who received eribulin. Delay administration of eribulin until resolution to Grade 2 or less
  • Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days)
  • Peripheral neuropathy (5%) was the most common adverse reaction resulting in discontinuation
Pregnancy Category D
  • Eribulin is expected to cause fetal harm when administered to a pregnant woman and patients should be advised of these risks
QT Prolongation
  • In an uncontrolled ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no prolongation on Day 1. ECG monitoring is recommended for patients with congestive heart failure; bradyarrhythmias; concomitant use of drugs that prolong QT interval, including Class Ia and III antiarrhythmics; and electrolyte abnormalities
  • Correct hypokalemia or hypomagnesemia prior to initiating eribulin and monitor electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome
Hepatic and Renal Impairment
  • For patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate or severe (CrCl 15-49 mL/min) renal impairment, a reduction in starting dose is recommended
Most Common Adverse Reactions
  • Most common adverse reactions (≥25%) reported in patients receiving eribulin were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%)
  • The most common serious adverse reactions reported in patients receiving eribulin were febrile neutropenia (4%) and neutropenia (2%)
For more information about eribulin, click here for the full Prescribing Information.
About Netupitant/Palonosetron (Available as AKYNZEO®) Netupitant/palonosetron (NEPA) is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. NEPA is an oral fixed combination of a 5-HT3 receptor antagonist, palonosetron, and an NK1 receptor antagonist, netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.
On March 26, 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending that NEPA be granted marketing authorization in the European Union for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin‑based cancer chemotherapy and moderately emetogenic cancer chemotherapy.
Important Safety Information
Warnings and Precautions
  • Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists
  • Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.  Serotonin syndrome can be life threatening.  Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue NEPA and initiate supportive treatment.  Patients should be informed of the increased risk of serotonin syndrome, especially if NEPA is used concomitantly with other serotonergic drugs
Adverse Reactions
  • Most common adverse reactions: headache, asthenia, dyspepsia, fatigue, constipation and erythema
Drug Interactions
  • Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with NEPA. The inhibitory effect on CYP3A4 can last for multiple days
    • Dexamethasone doses should be reduced when given with NEPA. A two-fold increase in the systemic exposure of dexamethasone was observed 4 days after single dose of netupitant
    • Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with NEPA. When administered with netupitant, the systemic exposure to midazolam was significantly increased
  • Avoid concomitant use of NEPA in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of NEPA
Use in Specific Populations
  • Avoid use of NEPA in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease
NEPA is available by prescription only.
For more information about NEPA, click here for the full Prescribing Information.
About Palonosetron HCl (available as ALOXI®)
Indication in Pediatrics Palonosetron injection 20mcg/kg (max 1.5mg) is indicated in patients ≥ 1 month up to 17 years of age, for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic chemotherapy.
Indication in Adults Palonosetron injection 0.25 mg is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.
Important Safety Information
Contraindications
  • Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components
Warnings and Precautions
  • Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists
  • Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone, but particularly with the use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue palonosetron and initiate supportive treatment.  Patients should be informed of the increased risk of serotonin syndrome, especially if palonosetron is used concomitantly with other serotonergic drugs.  
Adverse Reactions
  • In pediatric patients, while they require a higher dose of palonosetron, the safety profile is consistent with the established profile in adults; however, adverse reactions were reported in <0.1% of pediatric patients
  • In adults, the most commonly reported adverse drug reactions include headache (9%) and constipation (5%)
Palonosetron is available by prescription only.
For more information about palonosetron, click here for the full Prescribing Information.
About Helsinn and EisaiHelsinn signed a licensing agreement with Eisai Inc. granting Eisai commercial rights for NEPA in the United States. Under the terms of the agreement, Helsinn is responsible for conducting all development activities, obtaining regulatory approvals and holding the New Drug Application (NDA). NEPA is co-promoted in the United States by Eisai Inc. and Helsinn Therapeutics U.S. Inc., the U.S. subsidiary of Helsinn.
About the Helsinn GroupHelsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the U.S. and a representative office in China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.
Helsinn Group in-licenses early-to-late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn's products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn's products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers. Further information on Helsinn Group is available at www.helsinn.com.
About Eisai Inc.At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
About the SFJ Pharmaceuticals GroupThe SFJ Pharmaceuticals Group, which includes SFJ Pharma Ltd., is a global drug development company, which provides a unique co-development partnering model for some of the world's top pharmaceutical and biotechnology companies. SFJ uses its financial strength and core team of pharmaceutical development experts to provide highly customized partnering models in which SFJ provides the funding and clinical development supervision, necessary to obtain regulatory approval for some of the most promising drug development programs of pharmaceutical and biotechnology companies.

Contacts:
Media Inquiries
Laurie Landau
Eisai Inc.
(201) 746-2510
Investor Inquiries
Alex Scott
Eisai Inc.
(201) 746-2177

SOURCE Eisai Inc.


RELATED LINKS
http://www.eisai.com

Friday, May 15, 2015

"Happiness Is A Goal Of Life"

WINSTON-SALEM, N.C., May 14, 2015 /Cheryl Boone Isaacs, president of the Academy of Motion Picture Arts and Sciences (AMPAS), told graduates of the University of North Carolina School of the Arts (UNCSA) during her commencement address on May 9 at the Stevens Center in downtown Winston-Salem.
-- Artists are responsible for protecting freedom of expression,
"As the world becomes smaller and more globally connected, you as artists have a responsibility to protect freedom of expression and ensure that no one's voice is silenced by threats, violence or prejudice, and that different opinions can be shared without fear of personal or professional attack," she said.
Boone Isaacs is serving her second term as president of the 7,000-member Academy, presenter of the Oscars.
"Every year at the Oscars we honor the courage of filmmakers who cross borders and test boundaries, who give voice to challenging ideas and alternative points of view, and who encourage us to see the world and those around us in new ways," she said. "As you embark on the next phase of your careers in the arts, I hope you will carry that torch, tell the truth about the world as you perceive it and change the narrative."
Boone Isaacs told 235 recipients of bachelor of fine arts, bachelor of music, master of fine arts and master of music degrees they should remain faithful to their aspirations: "I want you all to follow your passion. There may be detours … but just keep moving forward. Stay focused on your goals and dreams. Happiness is a goal of life."
She noted that "there will be times when your passion has to take a back seat to the need to earn money. A career in the arts does not guarantee financial stability, but if you're smart about finding ways to monetize the work you love, the rewards will be immense."
As head of CBI Enterprises, Inc., Boone Isaacs has consulted on marketing efforts on such films as THE CALL, THE ARTIST, THE KING'S SPEECH, PRECIOUS: BASED on the NOVEL "PUSH" BY SAPPHIRE, SPIDER-MAN 2 and TUPAC: RESURRECTION. Previously, she oversaw marketing for New Line Cinema's box office hits including AUSTIN POWERS: THE SPY WHO SHAGGED ME and RUSH HOUR; and for Paramount Pictures she orchestrated publicity campaigns for the Best Picture winners FORREST GUMP and BRAVEHEART. 
"As a marketing and public relations executive both at major studios and independent companies, I have had to learn to maneuver both sides of the show business equation – the show side and the business side," she said. "As creative artists nowadays, it's incumbent on you to understand the business of the arts."
Boone Isaacs told the graduates their conservatory education will serve them well. "It's hard to see it now, but your time here will fundamentally shape the way you look at the world, solve problems and challenges, and build a sustainable future," she said.
Technological advancements offer countless opportunities to this generation of graduates, she said, but technology has not altered "the human love of storytelling – whether it is music, painting, literature, dance or film."
She also asked the graduates to "give back to the community through the nonprofit sector. There are so many youngsters who never get the chance to experience the arts. I urge you to support arts education for the underserved."
In closing, Boone Isaacs advised graduates to "bring the light of humanity and inspiration that you found here at UNC School of the Arts to the world around you."
Presiding over his first UNCSA commencement, Chancellor Lindsay Bierman spoke of mixed emotions. "I've loved seeing your work in our shops and studios, and on our stages and screens. But I'm personally very, very sad to see you go," he said. "Wherever you go from here, I want you to know this: I will always admire your creativity, respect your individuality, and applaud your extraordinary talents. The past two semesters together have made me one of your biggest lifelong fans."
Wearing custom-designed academic regalia created by UNCSA costume design faculty and students, Bierman asked graduates to recall the moment they informed their parents of their career choice.  "Parents, let's be honest. Some of you took the news pretty hard at first," he said. "You might have hoped for finance, or engineering.
"But you knew, in your heart, that your child has a rare ability and passion that must be cultivated and nurtured and protected. That success is defined by doing what you love, and loving what you do. That your child's unique gift, discipline, and focus would be highly valued and developed at a conservatory. That being true to oneself, and following one's calling, can lead to the richest and most rewarding life of all."
Honorary doctorates were presented during the ceremony to Boone Isaacs and to Dean Emeritus John Sneden, who led the School of Design and Production from 1970 to 2003 and established the first graduate program at the School of the Arts.
Celebrating its 50th anniversary, the University of North Carolina School of the Arts is America's first state-supported arts school, a unique stand-alone public university of arts conservatories. With a high school component, UNCSA is a degree-granting institution that trains young people of talent in music, dance, drama, filmmaking, and design and production. Established by the N.C. General Assembly in 1963, the School of the Arts opened in Winston-Salem ("The City of Arts and Innovation") in 1965 and became part of the University of North Carolina system when it was formed in 1972. For more information, visit www.uncsa.edu.

SOURCE University of North Carolina School of the Arts


RELATED LINKS
http://www.uncsa.edu

Saturday, May 9, 2015

Rolls-Royce Motor Cars' Latest Creation

NEW YORK, May 8, 2015 New York City. The global debut of this stunning new motor car will be the highlight of an exclusive event, Pratt Presents Women of Influence in the Business of Style, organized by Pratt Institute, the world-renowned art and design school located in the heart of New York City.  Rolls-Royce Motor Cars chose New York for this global debut because the "City that Never Sleeps" and the world's leading luxury brand share an innovative fashion spirit and sense of cool, modern luxury.

Rolls-Royce Motor Cars will share the event globally for media, owners and brand aficionados worldwide with a live stream of the activities on PERISCOPE©. TWITTER© users following of @RollsRoyceCars can download the app to not only view the festivities, but also to share real-time commentary and pose questions. Participants will include Michelle Lusby, a rising star of the Rolls-Royce Bespoke design team who has led innovation in the treatment of textiles and materials for the brand.  To participate in the event, users can download the free app from the iTunes App Store  and then follow the authenticated @RollsRoyceCars feed.  The New York based "RRWraithFashion" event will begin online broadcast 8 May 2015 at 4:15 p.m. EDT (9:15 p.m. BST, 10:15 p.m. CET.) The launch will also be tagged on social media channels using #RRFashion. 


Wraith 'Inspired by Fashion' represents the latest expression of innovative design for the resurgent Rolls-Royce Motor Car. Fashion has a way of moving forward like no other industry.  Timeless designs are reinvented to create brave new icons that challenge us to think differently. This was the defining concept behind the development of Wraith 'Inspired by Fashion,' The new vehicle sports numerous techniques and features never-before-seen on a Rolls-Royce Motor Car, including materials, colours and fabrics created by the Rolls-Royce Motor Cars Design Team. The "Pratt Presents Women of Influence in the Business of Style" event is a compelling opportunity to celebrate this inspiration new design and the designers whose craftsmanship and expertise created a motor car truly evocative of haute couture," said Giles Taylor, Director of Design for Rolls-Royce Motor Cars.
 "As a young designer in a dynamic field, it's important for me to share the exciting honour I've been given to help define the style and fashion of the most iconic luxury brand in the world.  Wraith 'Inspired by Fashion' provides and exquisite canvass to create a cool, daring and seductive motoring style, and I look forward to sharing our work with the world at the event in New York," said Michelle Lusby, Colour and Materials Designer for the Rolls-Royce Motor Car Bespoke Design Team.
"Pratt Presents is our signature series featuring visionary artists, designers and thought leaders who impact the cultural landscape and shape our future," said Ludovic Leroy, Executive Director, Strategic Partnerships & Institutional Support. "Aligning with women who have created, shaped, and innovated brands with a global reach is a perfect complement to spotlight Rolls-Royce Motor Cars design prowess and shared commitment to innovating aesthetically and technologically."
At Pratt Presents Women of Influence in the Business of Style, Rolls-Royce joins fashion powerhouses Maria Cornejo, designer, Zero + Maria Cornejo, Melisa Goldie, chief marketing officer, Calvin Klein, Inc. and Tracy Reese, founder and creative director, The Tracy Reese label, among others, for a panel discussion about female business leaders who are leading change in the fashion industry and profoundly impacting the market.
Notes to Editors
Further information:
You can find all our press releases and press kits, as well as a wide selection of high resolution, downloadable photographs and video footage at our media website, PressClub. You can also find the communications team at Rolls-Royce Motor Cars on Twitter.
Press contacts:
Goodwood
Regional
SOURCE Rolls-Royce Motor Cars

Tuesday, May 5, 2015

Fulfilling His Father's Dream: Martin Sheen Awarded University of Dayton Degree

DAYTON, Ohio, May 5, 2015 - It's a story Martin Sheen tells frequently.

After he graduated from high school, his father wanted him to go to the University of Dayton. But determined to start his acting career, he intentionally failed the school's entrance exam to convince his father otherwise.

Nearly 60 years later, the celebrated actor became a graduate of the University of Dayton May 3, "deeply moved" by the ceremony honoring him for a lifetime of humanitarian action that turned out to be the path to his father's dream.

The University awarded an honorary doctor of humane letters degree for his commitment to peace, social justice and human rights, exemplifying the Catholic, Marianist university's mission.

He accepted it as Ramon Estevez, the name he kept close as Martin Sheen's star rose, saying the ceremony, in combination with a family reunion a day earlier, resurfaced his father Francisco in a deeply personal way, and reminded him of the connection between the University and his family. Many members of his extended family attended, including sons Ramon and Emilio, grandchildren, four siblings and a host of other extended family members.

"I was not prepared for the deep emotional crack it made in me," he said in after the event. "This was about my dad. I had to come here, I had to celebrate him. I had to recognize him."

When he accepted a long-standing invitation from the University of Dayton to receive the honor, Sheen said he wasn't focused on the event, but memories and emotions stirred by his family's reunion put him in a different frame of mind.

"I began to realize that this was a celebration and I was very much a part of it, this University was so important to our lives. I learned last night I was practically born on K Street (now part of campus)," he said. His brothers Frank and Mike graduated from the University and his sister Carmen attended for two years before she left to join his growing family in New York.

"So this community is alive and deeply embedded in my being. And I had to celebrate that and I had not realized how really moving this would be and how important it would be. It was quite a celebration.

"I have been swept along by this extraordinary truth: that we all come from a place and we all want to stand for something."

In his speech, Sheen challenged the 1,441 graduates not only to stand for something but to act, to go out and see "the absolute need for justice, healing and mercy that unites us" and to "help heal our broken world wherever we may find it.

"We are all responsible for each other and the world. No one has ever made a contribution without personal suffering, self-sacrifice and sometimes even death."

Sheen grew up just a few blocks from the University and graduated from Chaminade High School, both founded by the Society of Mary, a Roman Catholic teaching order. He has said the Marianist teachings of the priests and brothers helped shape his commitment to social justice, service and peace.

A leader in human rights education, the University of Dayton established the nation's first undergraduate human rights studies program. More than 100 students have graduated from the program and pursued careers as human rights advocates and academics or humanitarian professionals in legal, governmental and nonprofit sectors.

SOURCE University of Dayton

RELATED LINKS
http://www.udayton.edu
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