Poor families plan to spend more than 5% of their income on prom this year, according to a new survey.
Families with a household income of less than $25,000 plan to spend $1,393 for the prom, according to Visa's annual nationwide survey on high school's most storied night.
Poor families spend $600 more on prom than wealthier ones - Mar. 31, 2015
Tuesday, March 31, 2015
April Fools! Virgin launches elaborate prank - Mar. 31, 2015
Richard Branson got a jump on April Fool's day with a characteristically over-the-top prank.
The Virgin Group CEO said Tuesday that the British company's U.S. operations would move to the heartland city of Branson, Missouri.
April Fools! Virgin launches elaborate prank - Mar. 31, 2015
The Virgin Group CEO said Tuesday that the British company's U.S. operations would move to the heartland city of Branson, Missouri.
April Fools! Virgin launches elaborate prank - Mar. 31, 2015
Low-wage workers plan major strike - Mar. 31, 2015
Labor activists announced plans Tuesday to hold what they're calling the largest-ever strike by low-wage workers.
A coalition of workers will walk off the job on April 15, according to the group known as Fight for $15.
Low-wage workers plan major strike - Mar. 31, 2015
A coalition of workers will walk off the job on April 15, according to the group known as Fight for $15.
Low-wage workers plan major strike - Mar. 31, 2015
Judge tells Robin Williams' family to settle out of court - Mar. 31, 2015
A judge hearing a dispute between Robin Williams' widow and his adult children has told them to try to settle their differences outside of court.
Williams' widow Susan Schneider Williams and her three adult stepchildren -- Zachary, Zelda and Cody Williams -- are arguing over who is entitled to some of the late actor's possessions, such as memorabilia, watches and other items.
Judge tells Robin Williams' family to settle out of court - Mar. 31, 2015
Williams' widow Susan Schneider Williams and her three adult stepchildren -- Zachary, Zelda and Cody Williams -- are arguing over who is entitled to some of the late actor's possessions, such as memorabilia, watches and other items.
Judge tells Robin Williams' family to settle out of court - Mar. 31, 2015
Iran nuclear deal could trigger an oil sell-off - Mar. 31, 2015
The fate of global oil prices will be determined in Lausanne, Switzerland this week.
An unlikely location for oil markets, to be sure, but that is where U.S. Secretary of State John Kerry is meeting with Iran's Mohammad Javad Zarif for intense negotiations over Iran's nuclear program. The so-called P5+1 countries and Iran hope to come to an 11th hour agreement that could pave the way for a historic thaw in relations. The deadline for a deal is the end of the month, or Tuesday night.
Iran nuclear deal could trigger an oil sell-off - Mar. 31, 2015
An unlikely location for oil markets, to be sure, but that is where U.S. Secretary of State John Kerry is meeting with Iran's Mohammad Javad Zarif for intense negotiations over Iran's nuclear program. The so-called P5+1 countries and Iran hope to come to an 11th hour agreement that could pave the way for a historic thaw in relations. The deadline for a deal is the end of the month, or Tuesday night.
Iran nuclear deal could trigger an oil sell-off - Mar. 31, 2015
Queen's royal workers locked in labor dispute at Windsor Castle - Mar. 31, 2015
A revolt is brewing at Windsor Castle.
Well, not that kind of revolt. A small group of workers at the Queen's residence are unhappy about what they say are low wages and unpaid duties.
Queen's royal workers locked in labor dispute at Windsor Castle - Mar. 31, 2015
Well, not that kind of revolt. A small group of workers at the Queen's residence are unhappy about what they say are low wages and unpaid duties.
Queen's royal workers locked in labor dispute at Windsor Castle - Mar. 31, 2015
Bank of America Launches Down Payment Resource Center to Help Prospective Buyers Find Programs to Help Achieve Homeownership | Bank of America Newsroom
The Bank of America Down Payment Resource Center Gives Consumers Access to a Searchable Database of Over 1,000 Local and National Assistance Programs in Time for Spring Homebuying Season
Bank of America Launches Down Payment Resource Center to Help Prospective Buyers Find Programs to Help Achieve Homeownership | Bank of America Newsroom
Bank of America Launches Down Payment Resource Center to Help Prospective Buyers Find Programs to Help Achieve Homeownership | Bank of America Newsroom
How the Surface lost $1 billion and lived to tell the tale - Mar. 31, 2015
Panos Panay had just nailed his presentation of the Surface 2 to 1,800 members of Microsoft's elated sales team, and the Surface chief was riding an all-time high.
It didn't last long.
How the Surface lost $1 billion and lived to tell the tale - Mar. 31, 2015
It didn't last long.
How the Surface lost $1 billion and lived to tell the tale - Mar. 31, 2015
Meet Microsoft's Jony Ive - Mar. 31, 2015
Apple has Jony Ive -- the design genius that makes its products slick, beautiful and easy to use.
Microsoft (MSFT, Tech30) has Panos Panay -- and he still has a lot to prove.
Meet Microsoft's Jony Ive - Mar. 31, 2015
Microsoft (MSFT, Tech30) has Panos Panay -- and he still has a lot to prove.
Meet Microsoft's Jony Ive - Mar. 31, 2015
Syndax and Merck to Collaborate on Immuno-Oncology Study Evaluating Entinostat in Combination with KEYTRUDA® (pembrolizumab) in Lung Cancer and Melanoma
From Merck:
Syndax and Merck to Collaborate on Immuno-Oncology Study Evaluating Entinostat in Combination with KEYTRUDA® (pembrolizumab) in Lung Cancer and Melanoma
Tuesday, March 31, 2015 8:00 am EDT
WALTHAM, Mass. & KENILWORTH, N.J.--(BUSINESS WIRE)--Syndax Pharmaceuticals, Inc., and Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that they have entered into a clinical trial collaboration to evaluate the safety and efficacy of combining Syndax’s entinostat, an investigational epigenetic therapy, with Merck’s KEYTRUDA®(pembrolizumab), the first anti-PD-1 therapy approved in the United States. The Phase 1b/2 study will evaluate this novel combination regimen in patients with either advanced non-small cell lung cancer (NSCLC) or melanoma. The study is expected to begin enrolling patients in the second half of 2015.
Entinostat is an oral, highly selective histone deacetylase (HDAC) inhibitor granted Breakthrough Therapy Designation in combination with hormone therapy in advanced hormone receptor positive (HR+) breast cancer and currently in Phase 3 testing in this indication. Entinostat has been shown in preclinical models to reduce the number and function of host immune suppressor cells thereby enhancing the anti-tumor activity of immune checkpoint blockade. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2.
"We are excited to be working with Merck on this collaboration to evaluate the potential of these two novel therapies to improve clinical outcomes for patients," said Arlene Morris, president and chief executive officer of Syndax. “We hope that entinostat in combination with KEYTRUDA may build upon the enormous promise of immunotherapy in treating multiple forms of cancer.”
“The broad base of clinical data involving our anti-PD-1 therapy, KEYTRUDA, continues to provide a strong foundation for advancing the study of different novel combination regimens,” said Dr. Eric Rubin, vice president and therapeutic area head, oncology early-stage development, Merck Research Laboratories. “Our collaboration with Syndax is an important example of this effort and our commitment to further the study of breakthrough science in the area of immuno-oncology to help people with cancer.”
The financial terms and additional details of the agreement between Syndax and Merck, through a subsidiary, were not disclosed. The agreement includes a provision where the parties may extend the collaboration to include a potential Phase 3 clinical trial. The planned Phase 1b/2 multicenter, open-label clinical trial will be conducted in two parts. The Phase 1b portion is designed to determine the safety and tolerability of entinostat in combination with KEYTRUDA. The Phase 2 portion is designed to evaluate the efficacy of entinostat combined with KEYTRUDA in patients with advanced NSCLC and melanoma.
About KEYTRUDA® (pembrolizumab)
KEYTRUDA (pembrolizumab) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merck is advancing a broad and fast-growing clinical development program for KEYTRUDA with more than 70 clinical trials – across more than 30 tumor types and over 8,000 patients – both as a monotherapy and in combination with other therapies.
Selected Important Safety Information for KEYTRUDA
Pneumonitis occurred in 12 (2.9%) of 411 patients with advanced melanoma receiving KEYTRUDA (the approved indication in the United States), including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 pneumonitis.
Colitis (including microscopic colitis) occurred in 4 (1%) of 411 patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%) patients respectively, receiving KEYTRUDA. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.
Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients, including a Grade 4 case in 1 (0.2%) patient, receiving KEYTRUDA. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.
Hypophysitis occurred in 2 (0.5%) of 411 patients, including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving KEYTRUDA. Monitor for signs and symptoms of hypophysitis. Administer corticosteroids for Grade 2 or greater hypophysitis. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3; and permanently discontinue KEYTRUDA for Grade 4 hypophysitis.
Nephritis occurred in 3 (0.7%) patients receiving KEYTRUDA, consisting of one case of Grade 2 autoimmune nephritis (0.2%) and two cases of interstitial nephritis with renal failure (0.5%), one Grade 3 and one Grade 4. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.
Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients respectively, receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411 patients, including a Grade 3 case in 1 (0.2%) patient, receiving KEYTRUDA. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer corticosteroids for Grade 3 or greater hyperthyroidism. Withhold KEYTRUDA for Grade 3; permanently discontinue KEYTRUDA for Grade 4 hyperthyroidism. Isolated hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.
Other clinically important immune-mediated adverse reactions can occur. The following clinically significant, immune-mediated adverse reactions occurred in less than 1% of patients treated with KEYTRUDA: exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis, hemolytic anemia, partial seizures arising in a patient with inflammatory foci in brain parenchyma, adrenal insufficiency, myasthenic syndrome, optic neuritis, and rhabdomyolysis.
For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement of the adverse reaction to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Restart KEYTRUDA if the adverse reaction remains at Grade 1 or less. Permanently discontinue KEYTRUDA for any severe or Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.
Based on its mechanism of action, KEYTRUDA may cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA.
For the treatment of advanced melanoma, KEYTRUDA was discontinued for adverse reactions in 6% of 89 patients who received the recommended dose of 2 mg/kg and 9% of 411 patients across all doses studied. Serious adverse reactions occurred in 36% of patients receiving KEYTRUDA. The most frequent serious adverse drug reactions reported in 2% or more of patients were renal failure, dyspnea, pneumonia, and cellulitis.
The most common adverse reactions (reported in ≥20% of patients) were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%), and diarrhea (20%).
The recommended dose of KEYTRUDA is 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity. No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA. It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA. Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.
About Syndax
Syndax is developing entinostat, an oral, highly selective HDAC inhibitor with epigenetic and immunomodulatory activity that is being evaluated in multiple combination regimens for the treatment of patients with therapy-resistant cancers. Entinostat has been designated a Breakthrough Therapy by the FDA when used in combination with exemestane in HR+ advanced (locally advanced or metastatic) breast cancer. A pivotal Phase 3 clinical study, being conducted under a special protocol assessment (SPA), combining entinostat with exemestane for the treatment of hormone receptor-positive metastatic breast cancer is currently enrolling. Syndax is also developing an immuno-oncology platform to improve responsiveness to checkpoint inhibitors based on entinostat’s ability to down-regulate immune suppressor cells. Syndax holds rights to entinostat in most major markets.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into biomedical innovations to help people with cancer worldwide. For Merck Oncology, helping people fight cancer is our passion, supporting accessibility to our cancer medicines is our commitment, and pursuing research in immuno-oncology is our focus to potentially bring new hope to people with cancer. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Merck Forward-Looking Statement
This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation in the United States and internationally; global trends toward healthcare cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information for KEYTRUDA (pembrolizumab) athttp://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and the Medication Guide for KEYTRUDA athttp://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf
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Toyota's Rav4 gets cheap automatic braking - Mar. 31, 2015
Toyota is bringing automatic braking to the masses.
The company is cutting the price of automatic braking and other crash-avoidance options, a move that could greatly increase the availability of the safety features.
Toyota's Rav4 gets cheap automatic braking - Mar. 31, 2015
The company is cutting the price of automatic braking and other crash-avoidance options, a move that could greatly increase the availability of the safety features.
Toyota's Rav4 gets cheap automatic braking - Mar. 31, 2015
7 Tools That Guarantee Great Project Management
You can accomplish amazing things in business when you have the right tools, both technological and social. This is especially true for managing company projects.
With some great tools in your arsenal, such as those that follow, you should be able to address all your project management needs.
7 Tools That Guarantee Great Project Management
Russia's Gazprom: Profits plunge 70% - Mar. 31, 2015
The crown jewel of Russian energy is losing its shine.
Gazprom (OGZPY), the world's biggest gas producer, saw its net profit fall 70% to 189 billion rubles ($3.3 billion) in 2014. The weak ruble was a big reason.
Russia's Gazprom: Profits plunge 70% - Mar. 31, 2015
Gazprom (OGZPY), the world's biggest gas producer, saw its net profit fall 70% to 189 billion rubles ($3.3 billion) in 2014. The weak ruble was a big reason.
Russia's Gazprom: Profits plunge 70% - Mar. 31, 2015
CBRE to purchase Johnson Controls' Global WorkPlace Solutions business for $1.475 billion
From Johnson Controls:
CBRE to purchase Johnson Controls' Global WorkPlace Solutions business for $1.475 billion
Strategic alliance expected to generate incremental revenues
MILWAUKEE, March 31, 2015 /PRNewswire/ -- Johnson Controls, Inc. (NYSE: JCI) announced today it has reached a definitive agreement for the sale of its Global WorkPlace Solutions (GWS) business to CBRE Group, Inc., for $1.475 billion. The company announced its intentions to divest the GWS business in September 2014 as part of its strategy to invest in product businesses that are core to its multi-industrial portfolio and growth objectives.
The agreement includes a 10-year strategic relationship between the two companies. Johnson Controls will be the preferred provider of HVAC equipment, building automation systems and related services to the 5 billion sq. ft. portfolio of real estate and corporate facilities managed globally by CBRE and GWS. The agreement provides Johnson Controls with new channels for its offerings and when fully operational is expected to generate up to $500 million of annual incremental revenue for the Johnson Controls Building Efficiency business.
"This agreement with CBRE is a great step for both companies that will allow each of us to build upon our core strengths to create new sources of value for our customers. GWS is a natural fit with CBRE's offerings, and together they will strategically take the business forward," said Alex Molinaroli, chairman and CEO, Johnson Controls. "In addition, the new strategic partnership provides another new, strong channel for Johnson Controls to serve CBRE and its clients around the world with our full portfolio of buildings technologies and services."
In connection with the agreement, CBRE will also provide Johnson Controls with a full suite of integrated corporate real estate services (including facilities management, project management and transaction services) on more than 50 million sq. ft. of Johnson Controls properties.
"The exceptionally talented GWS team will greatly enhance our service offering for occupiers around the world," said Bob Sulentic, president and chief executive officer of CBRE. "With GWS, we further our ability to create advantages for occupier clients by aligning every aspect of how they lease, own, use and operate real estate to enhance their competitive position."
In addition, the companies will jointly provide $40 million over 10 years to fund an innovation lab that will develop leading-edge energy management solutions to lower costs and enhance their clients' work environments. The joint innovation lab will evaluate, connect and leverage products, services and energy data to create value for occupiers and investors of real estate.
"This agreement is much more than a transaction," said Molinaroli. "It reflects our commitment to grow our buildings business, and is a long-term arrangement with significant mutual value and a strategic partnership that will drive sustainable growth for both companies."
Johnson Controls noted that it had recently completed the sale of its interests in two GWS-related joint ventures to Brookfield Asset Management, Inc. Including the joint venture transactions, aggregate proceeds from the GWS business divestitures are $1.675 billion.
Johnson Controls said it will treat GWS as a discontinued operation in the second quarter of fiscal 2015. The transaction is expected to close near the end of its 2015 fiscal year and is subject to regulatory clearance. BofA Merrill Lynch acted as the financial advisor to Johnson Controls, with Wachtell, Lipton, Rosen & Katz serving as legal advisor. The company will host an analyst call Tuesday March 31 at 10 a.m. CDT. It is available via webcast in the investor section ofhttp://www.johnsoncontrols.com/investors.
FORWARD-LOOKING STATEMENTS
Johnson Controls, Inc. has made statements in this document that are forward-looking and, therefore, are subject to risks and uncertainties. All statements in this document other than statements of historical fact are statements that are, or could be, deemed "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. In this document, statements regarding future financial position, sales, costs, earnings, cash flows, other measures of results of operations, capital expenditures or debt levels and plans, objectives, outlook, targets, guidance or goals are forward-looking statements. Words such as "may," "will," "expect," "intend," "estimate," "anticipate," "believe," "should," "forecast," "project" or "plan" or terms of similar meaning are also generally intended to identify forward-looking statements. Johnson Controls cautions that these statements are subject to numerous important risks, uncertainties, assumptions and other factors, some of which are beyond Johnson Controls' control, that could cause Johnson Controls' actual results to differ materially from those expressed or implied by such forward-looking statements. These factors include required regulatory approvals that are material conditions for proposed transactions to close, strength of the U.S. or other economies, currency exchange rates, and cancellation of or changes to commercial contracts, as well as other factors discussed in Item 1A of Part I of Johnson Controls' most recent Annual Report on Form 10-K for the year ended September 30, 2014. Shareholders, potential investors and others should consider these factors in evaluating the forward-looking statements and should not place undue reliance on such statements. The forward-looking statements included in this document are only made as of the date of this document, and Johnson Controls assumes no obligation, and disclaims any obligation, to update forward-looking statements to reflect events or circumstances occurring after the date of this document.
About Johnson Controls:
Johnson Controls is a global diversified technology and industrial leader serving customers in more than 150 countries. Our 170,000 employees create quality products, services and solutions to optimize energy and operational efficiencies of buildings; lead-acid automotive batteries and advanced batteries for hybrid and electric vehicles; and interior systems for automobiles. Our commitment to sustainability dates back to our roots in 1885, with the invention of the first electric room thermostat. Through our growth strategies and by increasing market share we are committed to delivering value to shareholders and making our customers successful. In 2014, Corporate Responsibility Magazine recognized Johnson Controls as the #12 company in its annual "100 Best Corporate Citizens" list. For additional information, please visit http://www.johnsoncontrols.com or follow @johnsoncontrols on Twitter.
About Johnson Controls Global WorkPlace Solutions
Johnson Controls Global WorkPlace Solutions (GWS) is a leading provider of facilities, corporate real estate and energy management for many of the world's largest companies. The company creates business advantage for its customers through tailored solutions that optimize their real estate performance and employee productivity while reducing total occupancy costs. Its 16,000 employees have delivered over $3 billion in savings for its customers over the last 10 years and ensures the business continuity for the 1.2 billion square feet of real estate that the company manages in 55 countries.
More CEOs join backlash over Indiana religious freedom law - Mar. 31, 2015
Indiana officials are facing a growing backlash from business leaders over a controversial law that critics say allows discrimination against gay people.
A group of CEOs representing nine leading Indiana businesses wrote to Governor Mike Pence and legislative leaders on Monday to express their concern about the impact of the law on the "reputation" of Indiana.
More CEOs join backlash over Indiana religious freedom law - Mar. 31, 2015
A group of CEOs representing nine leading Indiana businesses wrote to Governor Mike Pence and legislative leaders on Monday to express their concern about the impact of the law on the "reputation" of Indiana.
More CEOs join backlash over Indiana religious freedom law - Mar. 31, 2015
Hiring a Business Accountant: What You Need To Know
Tax time is fast approaching, and hopefully you have your financial records in order, but in case you don’t here’s some advice on how to hire an accountant. While there are many aspects of your business that you can handle on your own, accounting is one worth turning over to a professional. Accounting goes far beyond simply sending invoices and tracking expenses; a good accountant can also help you with your taxes, as well as find ways to keep cash flowing.
Hiring a Business Accountant: What You Need To Know
Hiring a Business Accountant: What You Need To Know
Biggest loser from the strong dollar: Emerging Markets - Mar. 31, 2015
The U.S. dollar is bullying the little guy: emerging markets.
The dollar's rapid rally -- the fastest in 40 years -- is great for the American traveler, but it's painful for many foreign countries and big businesses that operate abroad. Emerging market countries are arguably getting the worst of it.
Biggest loser from the strong dollar: Emerging Markets - Mar. 31, 2015
The dollar's rapid rally -- the fastest in 40 years -- is great for the American traveler, but it's painful for many foreign countries and big businesses that operate abroad. Emerging market countries are arguably getting the worst of it.
Biggest loser from the strong dollar: Emerging Markets - Mar. 31, 2015
The Biggest Branding Mistake Small Businesses Make
Whether you’re just starting a new small business or you’re already a successful small business owner, it’s very possible that you’re about to make (or you’ve already made) biggest branding mistake.
Don’t feel bad. You’re not alone, but it’s a mistake you should definitely fix as soon as possible because it could destroy your business.
The Biggest Branding Mistake Small Businesses Make
How Hong Kong's subway turns a $2 billion annual profit - Mar. 30, 2015
You can find one of Hong Kong's most profitable businesses about 30 meters below the earth's surface.
The city's subway is the face of the Mass Transit Railway Corporation (MTR) -- a publicly traded company that pulled in $5.2 billion in revenue last year.
How Hong Kong's subway turns a $2 billion annual profit - Mar. 30, 2015
The city's subway is the face of the Mass Transit Railway Corporation (MTR) -- a publicly traded company that pulled in $5.2 billion in revenue last year.
How Hong Kong's subway turns a $2 billion annual profit - Mar. 30, 2015
Lawn Care Services Offered on Amazon Soon
Could Amazon be the next place people go to hire a landscaper?
Starting today Monday March 30, small businesses in select markets nationwide will be able to offer services to customers through the eCommerce site up until now known mostly for selling products.
Lawn Care Services Offered on Amazon Soon
Magruder Hospital Signs Up For CommonWell Services
From Cerner:
Magruder Hospital Signs Up For CommonWell Services
March 30, 2015
Magruder Hospital will begin using CommonWell Health Alliance services to advance interoperability
KANSAS CITY, Mo. and PORT CLINTON, Ohio. — March 30, 2015 — Magruder Hospital announced today it signed up to use CommonWell Health Alliance™ services to enable health care providers to see patient health data from outside organizations within its Cerner electronic health record (EHR). Patients who receive care at its facilities will be able to give their doctors and nurses access to medical records from outside health care organizations that participate in CommonWell.
“Magruder Hospital is committed to providing treatment to people beyond the walls of the hospital,” said Chuck Dellick, Magruder Hospital director of information technology. “Signing up to use CommonWell services was an easy decision for us, since their approach to interoperability will help us connect to important patient information that happens outside of the hospital walls.”
By offering CommonWell services to its patients, Magruder Hospital is breaking through organizational and technological boundaries to advance interoperability and help patients give their care providers a more complete picture of their medical history. CommonWell services are expected to be live in July.
“Magruder Hospital is helping lead the charge for interoperability across health care,” said Bob Robke, CommonWell treasurer and Cerner vice president of Network Services. “Our organizations share a common belief that every person’s medical record should follow them, regardless of where they receive medical treatment or the type of EHR system that houses their records.”
CommonWell was founded by a group of health care IT suppliers committed to advancing interoperability by allowing different systems to work together in order to share patient health data with their care providers. The services offered by CommonWell will address four of the key challenges in health care interoperability:
- Patient identification and linking – Assist health IT suppliers to more quickly and accurately identify patients as they transition through care facilities
- Record locator and retrieval – Help providers locate and access their patient records, regardless of where the encounter occurred, by providing a “virtual table of contents” that documents available data from each encounter location
- Patient access, privacy and consent management – Expected future capabilities include a patient-authorized means to simplify management of data sharing consents and authorizations
- Trusted data access – Provide authentication and auditing services that facilitate secure data sharing among member systems
Interoperability in health care enables organizations to share patient information regardless of organizational, geographic or technological boundaries. When people can securely share important medical information with providers, they can help improve care quality by giving providers a more complete picture of their medical history.
About Magruder Hospital
Magruder Hospital, located in Port Clinton, Ohio, is a nonprofit critical access hospital. As a state-of-the-art hospital, Magruder employs nearly 400 people. The hospital has 30 active and 120 courtesy staff physicians in an array of specialties. Its 24-hour emergency room, physician practices, and a large variety of outpatient and inpatient services, allows it to meet the healthcare needs of the communities it serves. Magruder’s personal commitment to “service excellence” has made it one of the leading hospitals in the nation for patient satisfaction, quality and outcomes. For more information about Magruder, go to magruderhospital.com or join us on facebook at facebook.com/magruderhospital.
About CommonWell Health Alliance
CommonWell Health Alliance is a not-for-profit trade association of health IT companies working together to create universal access to health care data. The Alliance is open to all organizations that are committed to making patient’s data available to providers regardless of where care occurs. Alliance members support the belief that provider access to this data must be built into health information technologies at a reasonable cost for use by a broad range of health care providers and the populations and people they serve.
To learn more about CommonWell Health Alliance, please visit www.commonwellalliance.org, and read CommonWell Community blog. Also follow CommonWell on Twitter at @CommonWell, join us on CommonWell’s LinkedIn page, and like CommonWell’s Facebook page.
CommonWell Health Alliance and the CommonWell logo are licensed trademarks of CommonWell Health Alliance in the U.S. and other jurisdictions.
About Cerner
Cerner’s health information technologies connect people, information and systems at more than 18,000 facilities worldwide. Recognized for innovation, Cerner solutions assist clinicians in making care decisions and enable organizations to manage the health of populations. The company also offers an integrated clinical and financial system to help health care organizations manage revenue, as well as a wide range of services to support clients’ clinical, financial and operational needs. Cerner’s mission is to contribute to the improvement of health care delivery and the health of communities. On February 2, 2015, Cerner Corporation acquired substantially all of the assets, and assumed certain liabilities, of the Siemens Health Services business from Siemens AG. Nasdaq: CERN. For more information about Cerner, visit cerner.com, read our blog at cerner.com/blog, connect with us on Twitter at twitter.com/cerner and on Facebook at facebook.com/cerner.
Certain trademarks, service marks and logos set forth herein are property of Cerner Corporation and/or its subsidiaries. All other non-Cerner marks are the property of their respective owners.
Why You Should Use Credit Reports to Vet B2B Customers
You probably wouldn’t dream of loaning large amounts of money without credit information on the borrower, right?
But do you pull credit reports on the companies with whom you do business?
Why You Should Use Credit Reports to Vet B2B Customers
Monday, March 30, 2015
Amgen To Present At The Goldman Sachs Key Debates In Biosimilars Conference
From Amgen:
Amgen To Present At The Goldman Sachs Key Debates In Biosimilars Conference
THOUSAND OAKS, Calif., March 30, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) will present at the Goldman Sachs Key Debates in Biosimilars conference at 9:05 a.m. ET on Thursday, April 2, 2015, at the Goldman Sachs Conference Center in New York City. Scott Foraker, vice president and general manager of biosimilars at Amgen, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen's website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen's website for 90 days following the event.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
Amgen To Present At The Goldman Sachs Key Debates In Biosimilars Conference
THOUSAND OAKS, Calif., March 30, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) will present at the Goldman Sachs Key Debates in Biosimilars conference at 9:05 a.m. ET on Thursday, April 2, 2015, at the Goldman Sachs Conference Center in New York City. Scott Foraker, vice president and general manager of biosimilars at Amgen, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen's website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen's website for 90 days following the event.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
Linear Technology PR: LTC3887 Dual Synchronous Step-Down DC/DC Controller with Digital Power System Management & Fast 70ms Start-Up
MILPITAS, CA - March 30, 2015 - Linear Technology Corporation announces the LTC3887, a dual output synchronous step-down DC/DC controller with I²C-based PMBus interface for digital power system management. The LTC3887 differs from the previously released LTC3880 with an enhanced feature set that includes a faster 70ms power-up time, higher output voltage capability and a fast ADC mode that provides an 8ms update rate for one parameter. In addition, the LTC3887 and LTC3880 have a common board footprint. The LTC3887 combines best in class analog switching regulator performance with precision mixed signal data conversion for unsurpassed ease of power system design and management, supported by the LTpowerPlay™ software development system with easy-to-use graphical user interface (GUI).
Linear Technology PR: LTC3887 Dual Synchronous Step-Down DC/DC Controller with Digital Power System Management & Fast 70ms Start-Up
Linear Technology PR: LTC3887 Dual Synchronous Step-Down DC/DC Controller with Digital Power System Management & Fast 70ms Start-Up
Retired Entrepreneur Launches Coconut's Fish Cafe in Paradise
Entrepreneur and cat lover Michael Phillips decided to return to the business world with his latest restaurant franchise … after retiring to paradise.
Phillips founded Coconut’s Fish Café in Khei, Hawai’i, on the island of Maui, opening the doors of the flagship restaurant in 2009.
CFO's viral video leaves him on food stamps - Mar. 30, 2015
A protest video against Chick-fil-A that went viral two years ago has left a former CFO on food stamps, unable to find work or support his family of six.
Adam Smith, 37, says that he and his family have had to move out of their dream house on 3-1/2 acres and into a small rented home near train tracks and an airport's flight path.
CFO's viral video leaves him on food stamps - Mar. 30, 2015
Adam Smith, 37, says that he and his family have had to move out of their dream house on 3-1/2 acres and into a small rented home near train tracks and an airport's flight path.
CFO's viral video leaves him on food stamps - Mar. 30, 2015
McDonald's will test all-day breakfast - Mar. 30, 2015
McDonald's is giving late sleepers and big breakfast fans something to smile about by serving McMuffins all day, everyday at some locations.
It will test out all-day breakfast at certain restaurants in the San Diego area beginning next month, the company said Monday.
McDonald's will test all-day breakfast - Mar. 30, 2015
It will test out all-day breakfast at certain restaurants in the San Diego area beginning next month, the company said Monday.
McDonald's will test all-day breakfast - Mar. 30, 2015
Preparation Is Personal for Those with Chronic Illnesses (NYSE:LLY)
My Diabetes Emergency Plan helps patients with diabetes prepare for severe weather emergencies and unexpected predicaments
Preparation Is Personal for Those with Chronic Illnesses (NYSE:LLY)
National Lineman Appreciation Day: When the lights go out, Duke Energy heroes shine - Duke Energy
CHARLOTTE, N.C. -
The lights go out. You see and hear tree limbs falling. Power poles and wire once powering your home lay on the ground.
The service that powers the lives of your family is no longer there.
The service that powers the lives of your family is no longer there.
National Lineman Appreciation Day: When the lights go out, Duke Energy heroes shine - Duke Energy
DreamWorks scores win with 'Home'. Thank Rihanna? - Mar. 30, 2015
The nightmare for DreamWorks Animation may be over. The beleaguered studio can thank Rihanna and Sheldon from "The Big Bang Theory" for the turnaround.
Shares of DreamWorks Animation (DWA) surged as much as 10% Monday thanks to the surprise box office success of "Home" -- which features the voices of Jim Parsons as an alien and "Umbrella" singer Rihanna as the little girl who befriends him.
DreamWorks scores win with 'Home'. Thank Rihanna? - Mar. 30, 2015
Shares of DreamWorks Animation (DWA) surged as much as 10% Monday thanks to the surprise box office success of "Home" -- which features the voices of Jim Parsons as an alien and "Umbrella" singer Rihanna as the little girl who befriends him.
DreamWorks scores win with 'Home'. Thank Rihanna? - Mar. 30, 2015
Ben Bernanke: from Fed Chair to blogger - Mar. 30, 2015
Ben Bernanke is stepping up his social media game.
Bernanke, who led the Federal Reserve through the recession, launched his economics blog with the Brookings Institution Monday.
Ben Bernanke: from Fed Chair to blogger - Mar. 30, 2015
Bernanke, who led the Federal Reserve through the recession, launched his economics blog with the Brookings Institution Monday.
Ben Bernanke: from Fed Chair to blogger - Mar. 30, 2015
Boom! The Dow surged more than 260 points - Mar. 30, 2015
Remember all those worries about earnings and the economy that caused a big slump on Wall Street last week?
Yup, investors have forgotten all that. The market is back in rally mode. The Dow rose more than 260 points Monday, or 1.5%. The S&P 500 and Nasdaq both rose more than 1% as well.
Boom! The Dow surged more than 260 points - Mar. 30, 2015
Yup, investors have forgotten all that. The market is back in rally mode. The Dow rose more than 260 points Monday, or 1.5%. The S&P 500 and Nasdaq both rose more than 1% as well.
Boom! The Dow surged more than 260 points - Mar. 30, 2015
GNC boosts quality control of herbal supplements - Mar. 30, 2015
GNC, the leading retailer of dietary supplements, agreed Monday to beef up its testing and quality control standards for herbal supplements.
The announcement comes after New York Attorney General Eric Schneiderman accused GNC and other major retailers of selling herbal supplements that contained fillers and contaminants that could be harmful to consumers.
GNC boosts quality control of herbal supplements - Mar. 30, 2015
The announcement comes after New York Attorney General Eric Schneiderman accused GNC and other major retailers of selling herbal supplements that contained fillers and contaminants that could be harmful to consumers.
GNC boosts quality control of herbal supplements - Mar. 30, 2015
This man bet $100K that there's a startup bubble - Mar. 30, 2015
One man is betting $100,000 that there is -- in fact -- a tech bubble. But he's hardly an adamant bubble theorist.
Many in the industry have been sounding warning bells about a possible bubble, citing early-stage startups attracting millions in investment at sky-high valuations, despite having little or no revenue.
This man bet $100K that there's a startup bubble - Mar. 30, 2015
Land Rover's new $200,000 SUV is most expensive ever - Mar. 30, 2015
The most expensive SUV just got even pricier.
Land Rover unveiled the new high end version of the Range Rover, the SVAutobiography at the New York auto show Monday, which has a $199,495 price tag. That's up about $12,000 from the suggested price on the Autobiography Black model, which it replaces.
Land Rover's new $200,000 SUV is most expensive ever - Mar. 30, 2015
Land Rover unveiled the new high end version of the Range Rover, the SVAutobiography at the New York auto show Monday, which has a $199,495 price tag. That's up about $12,000 from the suggested price on the Autobiography Black model, which it replaces.
Land Rover's new $200,000 SUV is most expensive ever - Mar. 30, 2015
FDA Grants Amgen Priority Review for Kyprolis® (Carfilzomib) Supplemental New Drug Application for the Treatment of Relapsed Multiple Myeloma
From Amgen:
FDA Grants Amgen Priority Review for Kyprolis® (Carfilzomib) Supplemental New Drug Application for the Treatment of Relapsed Multiple Myeloma
Application Designed to Support Conversion of Accelerated to Full FDA Approval
THOUSAND OAKS, Calif., March 30, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is designed to support the conversion of accelerated approval to full approval and expand the current Kyprolis indication. As part of the acceptance, the FDA granted Kyprolis priority review with a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2015.
"Achieving deep and durable responses for patients with relapsed multiple myeloma is critical towards extending the time they live without their disease progressing," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The FDA's priority review designation for Kyprolis underscores the need for new treatment options for patients with relapsed multiple myeloma, and we look forward to working with regulatory authorities throughout the review process."
The sNDA is based on data from the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial and other relevant data.
Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.1
Kyprolis is currently approved by the FDA for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy.
About ASPIRE
The international, randomized Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial evaluated Kyprolis in combination with lenalidomide and low-dose dexamethasone, versus lenalidomide and low-dose dexamethasone alone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens. The primary endpoint of the trial was progression-free survival, defined as the time from treatment initiation to disease progression or death. Secondary endpoints included overall survival, overall response rate, duration of response, disease control rate, health-related quality of life and safety. Patients were randomized to receive Kyprolis (20 mg/m2 on days 1 and 2 of cycle 1 only, escalating to 27 mg/m2 on days 8, 9, 15 and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15 and 16 of subsequent cycles), in addition to a standard dosing schedule of lenalidomide (25 mg per day for 21 days on, 7 days off) and low-dose dexamethasone (40 mg per week in 4 week cycles), versus lenalidomide and low-dose dexamethasone alone. The study randomized 792 patients at sites in North America, Europe and Israel.
The ASPIRE data were presented at the 56th Annual Meeting of the American Society of Hematology in December 2014 and published in the New England Journal of Medicine.
The European Medicines Agency (EMA) provided Scientific Advice on the design and planned analysis of the ASPIRE trial and it was conducted under a Special Protocol Assessment (SPA) from the FDA.
About Multiple Myeloma
Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow.1,2 Worldwide, nearly 230,000 people are living with multiple myeloma and approximately 114,000 new cases are diagnosed annually.3 In the U.S., there are nearly 96,000 people living with, or in remission from, multiple myeloma. The estimated number of new cases of multiple myeloma in 2014 was more than 24,000 and the estimated number of deaths was 11,090.4 In Europe, approximately 89,000 people are living with the disease and in 2012 there was an estimated 39,000 newly diagnosed cases and 24,000 deaths.3
About Kyprolis® (carfilzomib) for Injection
On July 20, 2012, the U.S. FDA granted accelerated approval of Kyprolis® (carfilzomib) for Injection for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD) and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx Pharmaceuticals is a subsidiary of Amgen and holds development and commercialization rights to Kyprolis globally, excluding Japan. Kyprolis is also approved for use in Argentina, Israel and Mexico. For more information about Kyprolis, visit www.kyprolis.com.
Important Safety Information Regarding Kyprolis® (carfilzomib) for Injection
This safety information is specific to the current U.S. approved indication, which is based on Phase 2 studies.
Safety data have been evaluated in 526 patients with relapsed and/or refractory multiple myeloma who received single-agent Kyprolis. There were 37 deaths in the Phase 2 studies, or 7 percent of patients. The most common causes of death, other than disease progression, were cardiac events (5 patients), end-organ failure (4 patients) and infection (4 patients). Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia, pulmonary hypertension, pulmonary complications, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity and embryo-fetal toxicity.
Death due to cardiac arrest has occurred within a day of Kyprolis administration. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months and conduction abnormalities uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2 percent of patients treated with Kyprolis and was Grade 3 or greater in less than 1 percent of patients. Dyspnea was reported in 35 percent of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5 percent; no Grade 4 events and 1 death (Grade 5) was reported.
Infusion reactions, characterized by a spectrum of systemic symptoms including fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina can occur immediately following or up to 24 hours after administration of Kyprolis. Administration of dexamethasone prior to Kyprolis reduces the incidence and severity of reactions. Tumor lysis syndrome (TLS) occurred following Kyprolis administration in <1 percent of patients. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS.
Thrombocytopenia following Kyprolis administration resulted in a dose reduction in 1 percent of patients and discontinuation of treatment with Kyprolis in <1 percent of patients.
Cases of hepatic failure, including fatal cases, have been reported (<1 percent). Kyprolis can cause elevations of serum transaminases and bilirubin.
There are no adequate and well-controlled studies in pregnant women using Kyprolis. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis.
The most common serious adverse reactions were pneumonia, acute renal failure, pyrexia and congestive heart failure. The most common adverse reactions (incidence of 30 percent or greater) observed in clinical trials of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea and pyrexia. Serious adverse reactions were reported in 45 percent of patients.
Full prescribing information is available at www.kyprolis.com.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen Inc., including Amgen Inc.'s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen's business. Unless otherwise noted, Amgen is providing this information as of March 30, 2015, and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen and its partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen's products after they are on the market. Amgen's business may be impacted by government investigations, litigation and product liability claims. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.
In addition, sales of Amgen's products (including products of Amgen's wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of Amgen's products. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen and its partners routinely obtain patents for their products and technology, the protection of Amgen's products offered by patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen's or its partners' ability to obtain or maintain patent protection for Amgen's products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen's business and results of operations. Amgen's efforts to integrate the operations of companies it has acquired may not be successful. Cost saving initiatives may result in Amgen incurring impairment or other related charges on its assets. Amgen may experience difficulties, delays or unexpected costs and not achieve anticipated cost savings from its recently announced restructuring plan. Amgen's business performance could affect or limit the ability of Amgen's Board of Directors to declare a dividend or their ability to pay a dividend or repurchase Amgen common stock.
The scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
CONTACT:
Danielle Bertrand, 650-266-2114 (Media)
Cuyler Mayer, 805-447-6332 (Media)
Arvind Sood, 805-447-1060 (Investors)
References
Dimopoulos, M.A. Multiple Myeloma. Annals of Oncology 21 (Supplement 7): vii143–vii150, 2010.
National Cancer Institute. SEER Stat Fact Sheets: Myeloma. Available at: http://seer.cancer.gov/statfacts/html/mulmy.html. Accessed June 2014.
International Agency for Research on Cancer, GLOBOCAN 2012 database. Available at http://globocan.iarc.fr/. Accessed February 2014.
Leukemia & Lymphoma Society. Facts 2014-2015. http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/generalcancer/pdf/facts.pdf
Amgen Logo.
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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/fda-grants-amgen-priority-review-for-kyprolis-carfilzomib-supplemental-new-drug-application-for-the-treatment-of-relapsed-multiple-myeloma-300057440.html
SOURCE Amgen
FDA Grants Amgen Priority Review for Kyprolis® (Carfilzomib) Supplemental New Drug Application for the Treatment of Relapsed Multiple Myeloma
Application Designed to Support Conversion of Accelerated to Full FDA Approval
THOUSAND OAKS, Calif., March 30, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The sNDA is designed to support the conversion of accelerated approval to full approval and expand the current Kyprolis indication. As part of the acceptance, the FDA granted Kyprolis priority review with a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2015.
"Achieving deep and durable responses for patients with relapsed multiple myeloma is critical towards extending the time they live without their disease progressing," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The FDA's priority review designation for Kyprolis underscores the need for new treatment options for patients with relapsed multiple myeloma, and we look forward to working with regulatory authorities throughout the review process."
The sNDA is based on data from the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial and other relevant data.
Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.1
Kyprolis is currently approved by the FDA for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent (IMiD), and have demonstrated disease progression on or within 60 days of completion of the last therapy.
About ASPIRE
The international, randomized Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial evaluated Kyprolis in combination with lenalidomide and low-dose dexamethasone, versus lenalidomide and low-dose dexamethasone alone, in patients with relapsed multiple myeloma following treatment with one to three prior regimens. The primary endpoint of the trial was progression-free survival, defined as the time from treatment initiation to disease progression or death. Secondary endpoints included overall survival, overall response rate, duration of response, disease control rate, health-related quality of life and safety. Patients were randomized to receive Kyprolis (20 mg/m2 on days 1 and 2 of cycle 1 only, escalating to 27 mg/m2 on days 8, 9, 15 and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15 and 16 of subsequent cycles), in addition to a standard dosing schedule of lenalidomide (25 mg per day for 21 days on, 7 days off) and low-dose dexamethasone (40 mg per week in 4 week cycles), versus lenalidomide and low-dose dexamethasone alone. The study randomized 792 patients at sites in North America, Europe and Israel.
The ASPIRE data were presented at the 56th Annual Meeting of the American Society of Hematology in December 2014 and published in the New England Journal of Medicine.
The European Medicines Agency (EMA) provided Scientific Advice on the design and planned analysis of the ASPIRE trial and it was conducted under a Special Protocol Assessment (SPA) from the FDA.
About Multiple Myeloma
Multiple myeloma is the second most common hematologic cancer and results from an abnormality of plasma cells, usually in the bone marrow.1,2 Worldwide, nearly 230,000 people are living with multiple myeloma and approximately 114,000 new cases are diagnosed annually.3 In the U.S., there are nearly 96,000 people living with, or in remission from, multiple myeloma. The estimated number of new cases of multiple myeloma in 2014 was more than 24,000 and the estimated number of deaths was 11,090.4 In Europe, approximately 89,000 people are living with the disease and in 2012 there was an estimated 39,000 newly diagnosed cases and 24,000 deaths.3
About Kyprolis® (carfilzomib) for Injection
On July 20, 2012, the U.S. FDA granted accelerated approval of Kyprolis® (carfilzomib) for Injection for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent (IMiD) and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval was based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified.
Kyprolis is a product of Onyx Pharmaceuticals, Inc. Onyx Pharmaceuticals is a subsidiary of Amgen and holds development and commercialization rights to Kyprolis globally, excluding Japan. Kyprolis is also approved for use in Argentina, Israel and Mexico. For more information about Kyprolis, visit www.kyprolis.com.
Important Safety Information Regarding Kyprolis® (carfilzomib) for Injection
This safety information is specific to the current U.S. approved indication, which is based on Phase 2 studies.
Safety data have been evaluated in 526 patients with relapsed and/or refractory multiple myeloma who received single-agent Kyprolis. There were 37 deaths in the Phase 2 studies, or 7 percent of patients. The most common causes of death, other than disease progression, were cardiac events (5 patients), end-organ failure (4 patients) and infection (4 patients). Important warnings and precautions include cardiac arrest, congestive heart failure, myocardial ischemia, pulmonary hypertension, pulmonary complications, infusion reactions, tumor lysis syndrome, thrombocytopenia, hepatic toxicity and embryo-fetal toxicity.
Death due to cardiac arrest has occurred within a day of Kyprolis administration. Patients with New York Heart Association Class III and IV heart failure, myocardial infarction in the preceding 6 months and conduction abnormalities uncontrolled by medications were not eligible for the clinical trials. These patients may be at greater risk for cardiac complications.
Pulmonary arterial hypertension (PAH) was reported in 2 percent of patients treated with Kyprolis and was Grade 3 or greater in less than 1 percent of patients. Dyspnea was reported in 35 percent of patients enrolled in clinical trials. Grade 3 dyspnea occurred in 5 percent; no Grade 4 events and 1 death (Grade 5) was reported.
Infusion reactions, characterized by a spectrum of systemic symptoms including fever, chills, arthralgia, myalgia, facial flushing, facial edema, vomiting, weakness, shortness of breath, hypotension, syncope, chest tightness, or angina can occur immediately following or up to 24 hours after administration of Kyprolis. Administration of dexamethasone prior to Kyprolis reduces the incidence and severity of reactions. Tumor lysis syndrome (TLS) occurred following Kyprolis administration in <1 percent of patients. Patients with multiple myeloma and a high tumor burden should be considered to be at greater risk for TLS.
Thrombocytopenia following Kyprolis administration resulted in a dose reduction in 1 percent of patients and discontinuation of treatment with Kyprolis in <1 percent of patients.
Cases of hepatic failure, including fatal cases, have been reported (<1 percent). Kyprolis can cause elevations of serum transaminases and bilirubin.
There are no adequate and well-controlled studies in pregnant women using Kyprolis. Females of reproductive potential should be advised to avoid becoming pregnant while being treated with Kyprolis.
The most common serious adverse reactions were pneumonia, acute renal failure, pyrexia and congestive heart failure. The most common adverse reactions (incidence of 30 percent or greater) observed in clinical trials of patients with multiple myeloma were fatigue, anemia, nausea, thrombocytopenia, dyspnea, diarrhea and pyrexia. Serious adverse reactions were reported in 45 percent of patients.
Full prescribing information is available at www.kyprolis.com.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen Inc., including Amgen Inc.'s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.'s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen's business. Unless otherwise noted, Amgen is providing this information as of March 30, 2015, and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen and its partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen's products after they are on the market. Amgen's business may be impacted by government investigations, litigation and product liability claims. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.
In addition, sales of Amgen's products (including products of Amgen's wholly-owned subsidiaries) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of Amgen's products. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen's products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen and its partners routinely obtain patents for their products and technology, the protection of Amgen's products offered by patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen's or its partners' ability to obtain or maintain patent protection for Amgen's products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen's stock price may be affected by actual or perceived market opportunity, competitive position and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen's business and results of operations. Amgen's efforts to integrate the operations of companies it has acquired may not be successful. Cost saving initiatives may result in Amgen incurring impairment or other related charges on its assets. Amgen may experience difficulties, delays or unexpected costs and not achieve anticipated cost savings from its recently announced restructuring plan. Amgen's business performance could affect or limit the ability of Amgen's Board of Directors to declare a dividend or their ability to pay a dividend or repurchase Amgen common stock.
The scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.
CONTACT:
Danielle Bertrand, 650-266-2114 (Media)
Cuyler Mayer, 805-447-6332 (Media)
Arvind Sood, 805-447-1060 (Investors)
References
Dimopoulos, M.A. Multiple Myeloma. Annals of Oncology 21 (Supplement 7): vii143–vii150, 2010.
National Cancer Institute. SEER Stat Fact Sheets: Myeloma. Available at: http://seer.cancer.gov/statfacts/html/mulmy.html. Accessed June 2014.
International Agency for Research on Cancer, GLOBOCAN 2012 database. Available at http://globocan.iarc.fr/. Accessed February 2014.
Leukemia & Lymphoma Society. Facts 2014-2015. http://www.lls.org/content/nationalcontent/resourcecenter/freeeducationmaterials/generalcancer/pdf/facts.pdf
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