Today, Bank of America Merrill Lynch opens applications for its seventh UK Returning Talent programme. Individuals who have been out of work for 12 months or longer (former stay-at-home parents or carers, or someone who has chosen to take a career break, for example), are invited to apply via the company's Careers site. The application closing date is 6 December.
Bank of America Merrill Lynch Seventh Returning Talent Programme Opens for Applications | Bank of America Newsroom
Tuesday, November 1, 2016
Getting Business Funding Can be Daunting, but There's Hope
Vendedy is the first social network designed to connect global travelers to street markets. Founded by Forbes30Under30 Entrepreneur Christine Souffrant Ntim, the small business’s goal is to digitize the $10 trillion dollar street market economy and make it accessible to anyone and everyone.
Getting Business Funding Can be Daunting, but There's Hope
Getting Business Funding Can be Daunting, but There's Hope
Feds Short-changed Small Businesses Out of $200 Billion in Contracts in 2015 Alone, Says Advocacy Group
The United States government agency responsible for supporting entrepreneurs has been accused of short-changing small business owners out of $2 trillion in federal contracts over the last ten years.
Federal law currently dictates that small businesses must receive a minimum of 23 percent of all government contracts granted, and the Small Business Administration (SBA) is responsible for helping to ensure that target is met by connecting government agencies with business owners.
Feds Short-changed Small Businesses Out of $200 Billion in Contracts in 2015 Alone, Says Advocacy Group
Meet the man who spent $9 million on a license plate - Oct. 31, 2016
For high-rolling drivers in the United Arab Emirates, no car is complete without a single-digit license plate.
The oil-rich country's wealthy elite are willing to drop millions of dollars to get their hands on one.
Meet the man who spent $9 million on a license plate - Oct. 31, 2016
The oil-rich country's wealthy elite are willing to drop millions of dollars to get their hands on one.
Meet the man who spent $9 million on a license plate - Oct. 31, 2016
New Bristol-Myers Squibb Research on Opdivo (nivolumab) Monotherapy and in Combination With Yervoy (ipilimumab) at SMR 2016 Congress Reinforces Immuno-Oncology Leadership and Scientific Expertise in Melanoma | BMS Newsroom
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced new data presentations from studies evaluating Opdivo (nivolumab) as monotherapy or in combination with Yervoy (ipilimumab) in the treatment of melanoma, including new research on the efficacy and safety of the combination in melanoma patients with high unmet need including those with elevated serum lactate dehydrogenase (LDH) and brain metastases. Additional presentations will also highlight new data on health economics and real-world outcomes in patients living with the disease.
New Bristol-Myers Squibb Research on Opdivo (nivolumab) Monotherapy and in Combination With Yervoy (ipilimumab) at SMR 2016 Congress Reinforces Immuno-Oncology Leadership and Scientific Expertise in Melanoma | BMS Newsroom
New Bristol-Myers Squibb Research on Opdivo (nivolumab) Monotherapy and in Combination With Yervoy (ipilimumab) at SMR 2016 Congress Reinforces Immuno-Oncology Leadership and Scientific Expertise in Melanoma | BMS Newsroom
Monday, October 31, 2016
Why Small Business Share of U.S. Inventions is Declining
Small businesses are accounting for a smaller fraction of new technology creation than they used to, at least according data from the U.S. Patent and Trademark Office (USPTO). That trend has many policy makers and pundits concerned that our innovation system is handicapping small business.
While that explanation is possible, I think a more basic story accounts for the trend. Small business is a shrinking fraction of the U.S. economy.
Why Small Business Share of U.S. Inventions is Declining
Flying Cars Make Your Business Commute Like Something Out of The Jetsons (Watch)
Anyone who watched episodes of “The Jetsons” as a kid likely dreamed about one day riding around in a flying car. And that dream might actually turn into a reality sooner than you’d think.
Uber recently released a paper detailing the company’s desire to start a network of electric aircraft that can take off and land vertically. The company doesn’t plan to actually make those vehicles themselves. But there are others working on it already.
Flying Cars Make Your Business Commute Like Something Out of The Jetsons (Watch)
Hispanic-Owned Businesses See Revenue Spike, Says Biz2Credit Report
Hispanic-owned businesses are on a roll, reveals a new study.
According to the Biz2Credit Hispanic Small Business Credit Study, Hispanic-owned companies had average annual revenues of $202,327 in 2016, up from $68,540 the previous year.
Hispanic-Owned Businesses See Revenue Spike, Says Biz2Credit Report
10 Awesome Marketing Books for Holiday Gift Giving
Lifelong learning is an admirable goal. And in the world of marketing, it’s a requirement. The constant barrage of new platforms, channels and ways to engage with customers means that marketers have to stay on top of the latest practices if they want to be successful.
Today’s roundup of books will introduce you to trends, strategies and techniques that will help you connect and engage with your customers in an authentic natural way.
10 Awesome Marketing Books for Holiday Gift Giving
NextCon, #SalaryWins Chat Offer Different Small Business Event Options
If you’re looking for a helpful business event to attend in the next month, NextCon in Scottsdale offers actionable insights and inspiration for entrepreneurs looking to take their businesses to the next level.
But if you don’t have the time or resources to actually travel to a business event this month, you can still gain actionable tips and insights online. Small Business Trends, Accountemps and others are teaming up for a Twitter chat about salary levels and attracting the best employees this week.
NextCon, #SalaryWins Chat Offer Different Small Business Event Options
10 Ways to Keep Your Small Business Moving Forward
When you run a business, it’s important to always keep an eye on the future if you want your business to grow and improve. Members of our small business community understand what it takes to keep businesses moving forward. Here are some of their top tips.
10 Ways to Keep Your Small Business Moving Forward
10 Ways to Keep Your Small Business Moving Forward
25 Things You Need to Start a Photography Business
Looking to start a photography business? There are plenty of potential photography niches out there for small business owner. But no matter what you plan to actually photograph, there’s some essential equipment you’ll need. Here are 25 things you need to start a photography business.
25 Things You Need to Start a Photography Business
25 Things You Need to Start a Photography Business
Innovative Finance Provides the Link Between Capital and the Common Good
Capital and the Common Good: How Innovative Finance Is Tackling the World’s Most Urgent Problems challenges and transforms the often contentious relationship between business and social problems. Traditionally, businesses were seen as “profit first, social impact later”, but this is starting to change. Capital and the Common Good takes this renewed focus on business impact beyond the balance sheet to a whole new level. Instead of donating just things (like money or items), businesses can offer radically creative and profitable ways that can save the world and earn some money while doing it.
Innovative Finance Provides the Link Between Capital and the Common Good
Innovative Finance Provides the Link Between Capital and the Common Good
Donna Brazile out at CNN amid leaks to Clinton campaign - Oct. 31, 2016
Donna Brazile, the acting chairwoman of the Democratic National Committee, resigned from her role as a CNN contributor earlier this month.
Her departure was announced Monday amid fresh revelations that she sent questions to Hillary Clinton's campaign in advance of a CNN debate and a CNN-TV One town hall.
Donna Brazile out at CNN amid leaks to Clinton campaign - Oct. 31, 2016
Her departure was announced Monday amid fresh revelations that she sent questions to Hillary Clinton's campaign in advance of a CNN debate and a CNN-TV One town hall.
Donna Brazile out at CNN amid leaks to Clinton campaign - Oct. 31, 2016
‘China on European shopping tour’: German minister warns of Beijing’s takeovers of EU companies — RT Business
German Economy Minister Sigmar Gabriel has urged the European Union to adopt a tougher approach with China, citing his concerns over Beijing gaining the West's “strategically important key technologies.” He warned China’s WTO status was at stake.
‘China on European shopping tour’: German minister warns of Beijing’s takeovers of EU companies — RT Business
‘China on European shopping tour’: German minister warns of Beijing’s takeovers of EU companies — RT Business
Sunday, October 30, 2016
Guy Yehiav of Profitect: Prescriptive Analytics Gives You Next Best Actions to Go with Insights
You can’t go very long without hearing or reading about analytics today. And there’s no denying how important the insights coming from analytics is and will be to creating better customer experiences — and converting those experiences into revenue streams. But getting the insight is only part of the equation, as not knowing what to do with it can be just as bad as not having it.
Guy Yehiav of Profitect: Prescriptive Analytics Gives You Next Best Actions to Go with Insights
Guy Yehiav of Profitect: Prescriptive Analytics Gives You Next Best Actions to Go with Insights
UnitedHealth Group - Virginia Commonwealth University School of Nursing Receives Grant from UnitedHealthcare to Improve Access to Healthy Food for Seniors
RICHMOND, Va. (Oct. 27, 2016) —
UnitedHealth Group - Virginia Commonwealth University School of Nursing Receives Grant from UnitedHealthcare to Improve Access to Healthy Food for Seniors
A UnitedHealthcare grant to the Virginia Commonwealth University School of Nursing will help reduce hunger and social isolation among seniors by supporting the school's community-based care-coordination initiative, the Richmond Health and Wellness Program.
UnitedHealth Group - Virginia Commonwealth University School of Nursing Receives Grant from UnitedHealthcare to Improve Access to Healthy Food for Seniors
Bristol-Myers Squibb’s Yervoy (ipilimumab) Awarded Prix Galien USA Discovery of the Decade | BMS Newsroom
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that it received the Prix Galien USA Discovery of the Decade biotech award for Yervoy (ipilimumab), the Company’s recombinant, human monoclonal antibody. In honor of the 10th anniversary of the Prix Galien awards and recognizing this decade as one of history's most productive for research, this special honor distinguishes Bristol-Myers Squibb for its innovative discovery and development of Yervoy, which is now approved in more than 50 countries for treatment of unresectable or metastatic melanoma. The award is also a testament to Bristol-Myers Squibb’s efforts to establish Immuno-Oncology as a transformational approach to treating a wide range of malignancies.
Bristol-Myers Squibb’s Yervoy (ipilimumab) Awarded Prix Galien USA Discovery of the Decade | BMS Newsroom
Bristol-Myers Squibb’s Yervoy (ipilimumab) Awarded Prix Galien USA Discovery of the Decade | BMS Newsroom
Indian diamond dealer Savji Dholakia gives workers cars, apartments for Diwali - Oct. 28, 2016
Indian bosses traditionally give presents to staff at Diwali. Few can compete with the generosity of Savji Dholakia.
The founder of diamond dealer Hari Krishna Exports is giving away about 1,200 cars and 400 apartments to 1,700 of the company's employees.
Indian diamond dealer Savji Dholakia gives workers cars, apartments for Diwali - Oct. 28, 2016
The founder of diamond dealer Hari Krishna Exports is giving away about 1,200 cars and 400 apartments to 1,700 of the company's employees.
Indian diamond dealer Savji Dholakia gives workers cars, apartments for Diwali - Oct. 28, 2016
U.S. economy posts best growth in 2 years - Oct. 28, 2016
America finally got some good economic growth.
The U.S. economy expanded at a 2.9% annual rate from July through September compared with the same time a year ago -- the fastest economic growth in two years.
U.S. economy posts best growth in 2 years - Oct. 28, 2016
The U.S. economy expanded at a 2.9% annual rate from July through September compared with the same time a year ago -- the fastest economic growth in two years.
U.S. economy posts best growth in 2 years - Oct. 28, 2016
The Story of the Self Destruction of Deutsche Bank - SPIEGEL ONLINE
For most of its 146 years, Deutsche Bank was the embodiment of German values: reliable and safe. Now, the once-proud institution is facing the abyss. SPIEGEL tells the story of how Deutsche's 1990s rush to join the world banking elite paved the way for its own downfall.
The Story of the Self Destruction of Deutsche Bank - SPIEGEL ONLINE
The Story of the Self Destruction of Deutsche Bank - SPIEGEL ONLINE
Saturday, October 29, 2016
UPS Forecasts Record-Breaking Holiday Shipments
UPS (NYSE:UPS) plans record seasonal global delivery volume with an increase of more than 14 percent above the peak delivery period last year. The company and its customers benefit from two additional delivery days during 2016. This year the company expects to surpass 700 million packages delivered globally in 25 days between Thanksgiving and New Year’s Eve.
UPS Forecasts Record-Breaking Holiday Shipments
UPS Forecasts Record-Breaking Holiday Shipments
Yuengling beer owner endorses Donald Trump - Oct. 27, 2016
Donald Trump doesn't drink alcohol, but that didn't stop the owner of Yuengling beer from endorsing him.
Richard "Dick" Yuengling Jr. threw his support to Trump this week. He even gave Eric Trump a tour of the popular brewery in Pottsville, Pennsylvania. Yuengling Jr. is a billionaire and head of the 187-year-old beer company, which his great-great grandfather founded.
Yuengling beer owner endorses Donald Trump - Oct. 27, 2016
Richard "Dick" Yuengling Jr. threw his support to Trump this week. He even gave Eric Trump a tour of the popular brewery in Pottsville, Pennsylvania. Yuengling Jr. is a billionaire and head of the 187-year-old beer company, which his great-great grandfather founded.
Yuengling beer owner endorses Donald Trump - Oct. 27, 2016
Meeting the China E-Commerce Challenge
From the #USDA:
Digital strategies help promote U.S. food and agricultural products online to Chinese consumers. Since becoming the world’s largest e-commerce market in 2013, online shopping in China has continued to thrive.
In the United States, farming and technology go hand-in-hand in production agriculture. Technology helps improve productivity, efficiency and safety. Now, we’re discovering new ways that technology and digital strategies can offer similar benefits when marketing U.S. farm and food products overseas.
I recently led a group of women agricultural leaders on a trade mission to Shanghai and Hong Kong in China. One of the most interesting things we saw and learned was how e-commerce is paving the way for Chinese consumers to gain quick and easy access to high-value U.S. food and agricultural products. As a young, Chinese shopper explained to me, he purchases nearly 80 percent of his groceries online – skipping the trip to a traditional wet market or Western-style grocery store.
In Shanghai, a panel of industry experts joined us to discuss the importance of e-commerce in China. Last year, Chinese consumers spent $589.6 billion purchasing goods online, up 33.3 percent from the previous year. China has continued to dominate this form of marketing ever since it surpassed the United States to become the world’s largest e-commerce market in 2013.
While the total value of goods purchased online by Chinese consumers is impressive, what’s amazing is that many people see e-commerce as a way to buy fresh food. More and more shoppers want to buy products like live seafood, fresh fruits and vegetables and have those items arrive the next day. This is both a unique challenge and a tremendous opportunity for U.S. agribusinesses.
Asia is a key market for the United States and is only going to become more and more important over the next several decades. By 2030, 66 percent of the world’s middle class are going to reside in Asia. In China alone, 160 million middle class households will be added to China in the next decade. That’s a lot of buying power. Chinese consumers are looking for high-value, safe, quality food products at an affordable price. Those are all things that U.S. agriculture is poised to provide.
Now back from this trade mission, I want to underscore how critical it is to look at next steps to meet this challenge head on. To successfully do business in China, companies of every size need to have a digital strategy. If they haven’t already, our U.S. agribusiness partners and cooperators should begin exploring how to integrate this approach into their operations to continue moving forward in China’s growing e-commerce market.
For USDA, this growing opportunity drives home the importance of our market development programs. Along with our industry partners, we will need to explore ways we can help U.S. exporters meet China’s demand for U.S. food and agricultural products by capitalizing on the country’s e-commerce boom.
UPS Purchases 14 New 747-8F Jumbo Freighters
UPS (NYSE:UPS) today announced it has ordered 14 new Boeing 747-8 cargo jets to meet increased demand for the company’s air shipping services. UPS’s long term strategy is to increase customers’ access to global markets and air shipments are a major growth opportunity for the company. The 747-8s will enable UPS to begin a cascade of aircraft route reassignments that will add significant air capacity to the company’s busiest lanes, thereby optimizing global air network capacity well beyond the impact of adding new cargo jets.
UPS Purchases 14 New 747-8F Jumbo Freighters
UPS Purchases 14 New 747-8F Jumbo Freighters
I'm Ready to Offer Cloud as a Service, How Do I Assemble My Dream Team?
Information technology companies transitioning to become cloud-ready not only have to rethink their approach to servicing their small business clients but also hiring the types and categories of employees they will need to be successful.
Following is a list of roles, broken out by category, that comprise what might be referred to as a cloud-based IT business “dream team.” To some extent, it differs from the roles played by employees in traditional IT companies.
I'm Ready to Offer Cloud as a Service, How Do I Assemble My Dream Team?
The world's busiest Rolls-Royce dealership is in the Middle East - Oct. 27, 2016
Middle Eastern economies are reeling from low oil prices but that hasn't put a serious dent in Rolls-Royce sales.
Some customers have postponed purchases over the last few months, but Abu Dhabi -- capital of the United Arab Emirates -- is still home to the luxury automaker's busiest dealership in the world, Rolls-Royce CEO Torsten Muller-Otvos told CNNMoney.
The world's busiest Rolls-Royce dealership is in the Middle East - Oct. 27, 2016
Some customers have postponed purchases over the last few months, but Abu Dhabi -- capital of the United Arab Emirates -- is still home to the luxury automaker's busiest dealership in the world, Rolls-Royce CEO Torsten Muller-Otvos told CNNMoney.
The world's busiest Rolls-Royce dealership is in the Middle East - Oct. 27, 2016
Friday, October 28, 2016
UPS Drives Higher Profit In 3Q16
UPS (NYSE:UPS) today announced third-quarter 2016 diluted earnings per share of $1.44, a 3.6% increase over the same period last year. International operating profit increased 14% to $576 million, achieving the seventh consecutive quarter of double-digit growth.
UPS Drives Higher Profit In 3Q16
UPS Drives Higher Profit In 3Q16
86 Percent of Businesses Plan to Hire Part-Timers on Full Time After the Holiday
Most small businesses are more likely to retain their temporary workers after the holidays, a new survey has found.
According to Snagajob’s Holiday Hiring 2016 Annual Report, 86 percent of employers are likely to hire temporary workers full time after the holidays.
86 Percent of Businesses Plan to Hire Part-Timers on Full Time After the Holiday
Bristol-Myers Squibb Reports Third Quarter Financial Results | BMS Newsroom
NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today reported results for the third quarter of 2016 which were highlighted by strong sales and operating performance, and continued growth for key products including Opdivo andEliquis . The company raised full-year guidance for 2016 and provided guidance expectations for 2017, announced a new $3 billion share repurchase authorization, and announced an evolution of the company’s operating model to focus resources behind the company’s highest priorities, accelerate its pipeline and simplify infrastructure.
Bristol-Myers Squibb Reports Third Quarter Financial Results | BMS Newsroom
Bristol-Myers Squibb Reports Third Quarter Financial Results | BMS Newsroom
Tesla is Innovative - But Is It Reliable? (Watch)
Innovation and reliability don’t always go hand in hand – at least not for Tesla. The automotive company ranked 25 out of 29 in Consumer Reports’ latest reliability survey, which is a known standard in the industry.
Of course, the car company is known for being more innovative and cutting edge than many others in the industry. But some of its innovative features, like falcon wing doors, were sources of reliability problems. And then there are the well-documented issues with the company’s autopilot feature, which is still being tested. So this survey isn’t likely to do anything to calm people’s concerns.
Tesla is Innovative - But Is It Reliable? (Watch)
Thursday, October 27, 2016
Dirty Secrets of Small Business Revealed in New Radio Show
First time business owners often struggle to find their footing when setting up a new enterprise. Each hurdle presents new questions, and sometimes aspiring entrepreneurs haven’t got anywhere to turn to find answers.
Business partners Jack Mencini and Adam Sonnhalter have set out to change that through their weekly radio show.
Dirty Secrets of Small Business Revealed in New Radio Show
25 Legit Green Business Certifications
Consumers are becoming more savvy about green businesses and products. So if you want to make a claim about the environmental impact of your company, you may want to look into some certifications to offer some proof about your business’s environmental claims. Here are 25 green business certifications for you to consider.
25 Legit Green Business Certifications
25 Legit Green Business Certifications
VW and Dieselgate: Wolfgang Porsche and Hans Michel Piëch - SPIEGEL ONLINE
Volkswagen is struggling. The diesel emissions scandal, slim profit margins and a leadership shake-up have challenged the automobile company. SPIEGEL sat down with senior members of the family, Wolfgang Porsche and Hans Michel Piëch, to discuss the path out of the disaster.
VW and Dieselgate: Wolfgang Porsche and Hans Michel Piëch - SPIEGEL ONLINE
VW and Dieselgate: Wolfgang Porsche and Hans Michel Piëch - SPIEGEL ONLINE
Travelmate Represents Latest Attempt to Automate, Robotify Your Suitcase
From a suitcase you can ride known as Modobag to one that follows you loyally called Cowarobot, there is an evolution taking place in the luggage industry. The latest suitcase to incorporate connectivity, motorization and robotics is Travelmate, and it has features that can be very useful for the demanding business traveler.
Travelmate is a fully autonomous suitcase that uses your smartphone and GPS technology to ensure it will always be by your side. Although it is comparable to the Cowarobot, the technology and mechanics of the Travelmate are much more advanced.
Travelmate Represents Latest Attempt to Automate, Robotify Your Suitcase
Spotlight: Vacasa Takes the Work Out of Vacation Rentals
If you have a second home or rental property, you might think you have to utilize peer-to-peer services like Airbnb in order to gain some extra income from those properties. But some homeowners may not want to go through all the work of renting out their spaces on those platforms. That’s where Vacasa comes in.
You can read more about Vacasa and the services it provides to homeowners and vacationers in this week’s Small Business Spotlight.
Spotlight: Vacasa Takes the Work Out of Vacation Rentals
Merck Highlights Ongoing Commitment to Fighting Infectious Diseases with More than 30 Data Presentations at ID Week 2016 | Merck Newsroom Home
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that researchers will provide more than 30 scientific data presentations on the company’s established and investigational infectious disease medicines and vaccines at ID Week 2016 in New Orleans from Oct. 26-30.
Merck Highlights Ongoing Commitment to Fighting Infectious Diseases with More than 30 Data Presentations at ID Week 2016 | Merck Newsroom Home
Merck Highlights Ongoing Commitment to Fighting Infectious Diseases with More than 30 Data Presentations at ID Week 2016 | Merck Newsroom Home
4 Ways Small Businesses Can Do Advertising Right
Advertising can bring you quick success. That’s the reason it’s still in vogue and will continue to be so.
Small businesses need to shrug off the preconceived notion that advertising is uber-expensive. It’s not always expensive; getting started with Facebook ads costs only $50. Cost is not a legitimate concern because to fully harness the power of advertising, things must be done in the right ways.
The right ways include:
4 Ways Small Businesses Can Do Advertising Right
New Zealand is the easiest place in the world to do business - Oct. 26, 2016
Starting a new business in New Zealand takes less than one day. In Venezuela, it takes 230.
That startling difference helps explain why the World Bank has rated New Zealand as the easiest place on the planet to do business -- and why Venezuela languishes 187th out of 190 economies.
New Zealand is the easiest place in the world to do business - Oct. 26, 2016
That startling difference helps explain why the World Bank has rated New Zealand as the easiest place on the planet to do business -- and why Venezuela languishes 187th out of 190 economies.
New Zealand is the easiest place in the world to do business - Oct. 26, 2016
Big Banks Fall Behind, Try to Compete With Venmo (Watch)
U.S. banks are trying to take a chunk out of Venmo’s business. The money-transfer app has gained a lot of popularity in recent years. And banks are worried that it could cut into their business.
So big names like JPMorgan Chase & Co., S.S. Bancorp and Citibank have teamed up to create an app called Zelle. The app will have similar functionality but could stand apart because of its support from major financial institutions. Users will also get immediate access to funds for free on Zelle, which is something you don’t get with other transfer apps.
Big Banks Fall Behind, Try to Compete With Venmo (Watch)
Wednesday, October 26, 2016
UnitedHealth Group - More Than 360 Kids Participated in the New Hanover Regional Medical Center IRONKIDS North Carolina Fun Run
WILMINGTON, N.C. (Oct. 21, 2016) —
UnitedHealth Group - More Than 360 Kids Participated in the New Hanover Regional Medical Center IRONKIDS North Carolina Fun Run
More than 360 kids participated in the New Hanover Regional Medical Center IRONKIDS North Carolina Fun Run presented by UnitedHealthcare today at the Wilmington Downtown Riverwalk. UnitedHealthcare mascot Dr. Health E. Hound kicked off the fun run joined by Rebecca Bannister, regional marketing director of UnitedHealthcare.
UnitedHealth Group - More Than 360 Kids Participated in the New Hanover Regional Medical Center IRONKIDS North Carolina Fun Run
50 Business Ideas for Moms
Business ownership can certainly be time consuming. But if you’re a mom (or dad) and want to start a business while still having time to spend with your family, there are options out there.
There are so many successful mom entrepreneurs that can inspire your own entrepreneurial journey. Or you can start any of the businesses listed below that are perfect for mom (or dad) entrepreneurs.
50 Business Ideas for Moms
Morbark selects Syncron for aftermarket revenue optimization - Renewable Energy From Waste
Syncron, a Sweden-based aftermarket service provider with U.S. offices in Atlanta, that exclusively focuses on service parts management and pricing for the world’s leading manufacturers, has announced Morbark, a Winn, Michigan-based manufacturer of heavy-duty, high-performance equipment for the forestry, recycling, tree care, sawmill and biomass markets, has selected Syncron’s price management solution to optimize its aftermarket revenue and provide a better experience to both its dealers and customers
Morbark selects Syncron for aftermarket revenue optimization - Renewable Energy From Waste
Morbark selects Syncron for aftermarket revenue optimization - Renewable Energy From Waste
CUSTOMER RETENTION STATISTICS - The Ultimate Collection for Small Business
We’ve collected these customer retention statistics for small businesses from a variety of sources. Enjoy the list and see if any catch your attention that might be especially relevent to your company.
CUSTOMER RETENTION STATISTICS - The Ultimate Collection for Small Business
CUSTOMER RETENTION STATISTICS - The Ultimate Collection for Small Business
2016 U.S. Trust Study of High Net Worth Philanthropy Reveals Positive Giving and Volunteering Forecasts for the Coming Years | Bank of America Newsroom
New Study Offers Insight Into the Motivations, Expectations and Behaviors of Various Demographic Segments of Wealthy Donors
2016 U.S. Trust Study of High Net Worth Philanthropy Reveals Positive Giving and Volunteering Forecasts for the Coming Years | Bank of America Newsroom
2016 U.S. Trust Study of High Net Worth Philanthropy Reveals Positive Giving and Volunteering Forecasts for the Coming Years | Bank of America Newsroom
New Results Presented for Opdivo (nivolumab) Demonstrate Encouraging Response Rate in an Expanded Population of Heavily Pre-Treated Classical Hodgkin Lymphoma Patients
From Bristol-Myers Squibb:
New Results Presented for Opdivo (nivolumab) Demonstrate Encouraging Response Rate in an Expanded Population of Heavily Pre-Treated Classical Hodgkin Lymphoma Patients
First presentation of Phase 2 CheckMate -205 cohort C data in classical Hodgkin lymphoma patients following treatment with autologous hematopoietic stem cell transplantation and brentuximab vedotin
After a median follow-up of 8.8 months, Opdivo demonstrated an objective response rate as assessed by an independent radiologic review committee of 73% overall and median progression-free survival of 11.2 months
The safety profile of Opdivo was consistent with previously reported data in this tumor type, and no new clinically meaningful safety signals were identified
Tuesday, October 25, 2016 8:00 am EDT
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced new results from CheckMate -205, a multi-cohort, single-arm, Phase 2 trial evaluating Opdivo (nivolumab) in patients with classical Hodgkin lymphoma (cHL). These results from cohort C (n=100) of the trial included patients with cHL who had received brentuximab vedotin before and/or after autologous hematopoietic stem cell transplantation (auto-HSCT). After a median follow-up of 8.8 months, the primary endpoint of objective response rate (ORR) per an independent radiologic review committee (IRRC) was 73% (n=73; 95% CI: 63.2-81.4) overall, which was consistent across patient subgroups regardless of the timing of prior brentuximab vedotin relative to auto-HSCT. The ORR was 70% (n=23; 95% CI: 51.3-84.4) in patients who received brentuximab vedotin only before auto-HSCT; 72% (n=41; 95% CI: 58.5-83.0) in patients who received brentuximab vedotin only after auto-HSCT; and 88% (n=7; 95% CI: 47.3-99.7) in patients who received brentuximab vedotin before and after auto-HSCT. The safety profile of Opdivo was consistent with previously reported data in this tumor type, and no new clinically meaningful safety signals were identified.
These data will be presented at the 10th International Symposium on Hodgkin Lymphoma (ISHL) in Cologne, Germany on Tuesday, October 25 at 3:00 p.m. CEST (Abstract #0149). This abstract was awarded the Karl Musshoff Prize for the Best Clinical Research Abstract, which is granted every three years in conjunction with ISHL for outstanding results in the field of Hodgkin lymphoma.
“These data from cohort C build on existing evidence supporting the benefit of Opdivo in classical Hodgkin lymphoma patients who have relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin,” said Andreas Engert, M.D., study investigator and professor of Internal Medicine, Hematology and Oncology, University Hospital of Cologne, Cologne, Germany. “Results from cohort C indicated a benefit with Opdivo regardless of the order of prior treatment with autologous hematopoietic stem cell transplantation and brentuximab vedotin, providing important insights as we continue researching the potential role Opdivo could provide for heavily pre-treated classical Hodgkin lymphoma patients.”
In May 2016, the U.S. Food and Drug Administration approved Opdivo for the treatment of patients with cHL who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin based on a combined analysis of data from cohort B of CheckMate -205 and the Phase 1 CheckMate -039 trial. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
In October 2016, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended the approval of Opdivo for the treatment of adult patients with relapsed or refractory cHL after auto-HSCT and treatment with brentuximab vedotin based on data from cohort B of CheckMate -205 and CheckMate -039. The CHMP recommendation is now being reviewed by the European Commission, which has the authority to approve medicines for the European Union. Opdivo also is currently under regulatory review for cHL in Japan.
Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb, commented, “We continue to expand our Immuno-Oncology science in hematology, and these latest results from CheckMate -205 will help inform our research into classical Hodgkin lymphoma and aid us in determining whether Opdivo may provide benefit to a broader population of patients living with this difficult-to-treat disease.”
About CheckMate -205 Cohort C
Key efficacy results from cohort C of CheckMate -205 are summarized below.
Cohort C
Overall (n=100) |
BV Only Before
Auto-HSCT Subgroup (n=33) |
BV Only After
Auto-HSCT Subgroup (n=57) |
BV Before and
After Auto- HSCT Subgroup (n=8) | ||||
| ORR per IRRC, n (%)
[95% CI]
| 73 (73)
[63.2, 81.4]
| 23 (70)
[51.3, 84.4]
| 41 (72)
[58.5, 83.0]
| 7 (88)
[47.3, 99.7]
| |||
| Complete response, n (%)
[95% CI]
| 17 (17.0)
[10.2, 25.8]
| 6 (18.2)
[7.0, 35.5]
| 7 (12.3)
[5.1, 23.7]
| 3 (38)
[8.5, 75.5]
| |||
| Partial response, n (%)
[95% CI]
| 56 (56.0)
[45.7, 65.9]
| 17 (51.5)
[33.5, 69.2]
| 34 (59.6)
[45.8, 72.4]
| 4 (50.0)
[15.7, 84.3]
| |||
| 6-month PFS rate per IRRC, %
[95% CI]
| 76.6
[66.3, 84.2]
| 83.7
[65.1, 92.9]
| 71.2
[56.7, 81.6]
| 83.3
[27.3, 97.5]
| |||
| Median PFS, months
[95% CI]
| 11.2
[8.5, NA]
| 11.2
[8.5, NA]
| 8.9
[8.3, NA]
| NA
[5.6, NA]
| |||
| Median DOR, months
[95% CI]
| 7.0
[6.7, NA]
| 7.0
[6.7, NA]
| NA
[5.4, NA]
| NA
[3.3, NA]
| |||
| 6-month OS, %
[95% CI]
| 93.9
[86.9, 97.2]
| 97
[80, 100]
| 91
[80, 96]
| 100
[100, 100]
| |||
In CheckMate -205 cohort C, the safety profile of Opdivo was consistent with previously reported data in this tumor type, and no new clinically meaningful safety signals were identified. Treatment-related adverse events (AE) occurred in 68% of patients between the first dose and 30 days after the last dose of Opdivo. The most common treatment-related AEs were diarrhea, infusion-related reaction and fatigue (11% each). Grade 3/4 AEs occurred in 19% of patients. Serious treatment-related AEs were reported in 17% of patients, and treatment-related AEs leading to discontinuation occurred in 6% of patients. At present, no treatment-related deaths have been reported.
About CheckMate -205
CheckMate -205 is a Phase 2, open-label, international, multicenter, non-comparative, multi-cohort study that evaluated the safety and efficacy of Opdivo in adult patients with classical Hodgkin lymphoma (cHL). Cohort A included cHL patients who had received autologous hematopoietic stem cell transplantation (auto-HSCT) and who were brentuximab vedotin-naïve (n=63); cohort B included cHL patients who had received auto-HSCT followed by brentuximab vedotin (n=80); and cohort C included cHL patients who had received brentuximab vedotin before and/or after auto-HSCT (n=100). CheckMate -205 also includes cohort D, which is currently enrolling and evaluating Opdivo in combination with chemotherapy in newly diagnosed, advanced-stage cHL patients who are treatment-naïve (n=50).
Patients enrolled in this trial were treated with Opdivo 3 mg/kg intravenously every two weeks until disease progression or unacceptable toxicity; in cohort C, patients also were treated until investigator-assessed complete response (CR) lasting one year.
The primary endpoint of the study was objective response rate by independent radiologic review committee (IRRC) assessment. Secondary and other exploratory endpoints included duration of response (DOR) by IRRC assessment for CR rate and partial response rate, progression-free survival (PFS) by IRRC assessment, overall survival (OS) and safety.
About Classical Hodgkin Lymphoma
Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. Worldwide, there are about 66,000 new HL cases and 25,500 deaths from HL estimated each year. The disease is most often diagnosed in early adulthood (ages 20-40) and late adulthood (older than 55 years of age). Classical Hodgkin lymphoma is the most common type of HL, accounting for 95% of cases. There remains a significant unmet need for patients who relapse or who become refractory to approved treatments that are currently available.
Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research
At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines that will raise survival expectations in hard-to-treat cancers and will change the way patients live with cancer.
We are leading the scientific understanding of I-O through our extensive portfolio of investigational and approved agents, including the first combination of two I-O agents in metastatic melanoma, and our differentiated clinical development program, which is studying broad patient populations across more than 20 types of cancers with 11 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs uniquely position us to advance the science of combinations across multiple tumors and potentially deliver the next wave of I-O combination regimens with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and inform which patients will benefit most from I-O therapies.
We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 57 countries, including the United States, the European Union and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 47 countries, including the United States and the European Union.
INDICATIONS
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.
Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests at baseline and before each dose.
Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.
Immune-Mediated Pneumonitis
OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated pneumonitis occurred in 6% (25/407) of patients.
In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 4.9% (13/263) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 3.4% (9/263) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=8).
Immune-Mediated Colitis
OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis.
Immune-Mediated Hepatitis
OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated hepatitis occurred in 13% (51/407) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%.
Immune-Mediated Neuropathies
In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported.
Immune-Mediated Endocrinopathies
OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.
In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO with YERVOY, hypophysitis occurred in 9% (36/407) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO with YERVOY, adrenal insufficiency occurred in 5% (21/407) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO with YERVOY, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving OPDIVO with YERVOY. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO with YERVOY, diabetes occurred in 1.5% (6/407) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. 6 of the 9 patients were hospitalized for severe endocrinopathies.
Immune-Mediated Nephritis and Renal Dysfunction
OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients.
Immune-Mediated Skin Adverse Reactions and Dermatitis
OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO with YERVOY, immune-mediated rash occurred in 22.6% (92/407) of patients.
In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis.
Immune-Mediated Encephalitis
OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO with YERVOY (0.2%) after 1.7 months of exposure.
Other Immune-Mediated Adverse Reactions
Based on the severity of adverse reaction, permanently discontinue or withhold treatment, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO the following clinically significant immune-mediated adverse reactions occurred in <1.0% of patients receiving OPDIVO: uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), myositis, myocarditis, rhabdomyolysis, motor dysfunction, vasculitis, and myasthenic syndrome.
Infusion Reactions
OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy, infusion-related reactions occurred in 6.4% (127/1994) of patients. In patients receiving OPDIVO with YERVOY, infusion-related reactions occurred in 2.5% (10/407) of patients.
Complications of Allogeneic HSCT after OPDIVO
Complications, including fatal events, occurred in patients who received allogeneic HSCT after OPDIVO. Outcomes were evaluated in 17 patients from Checkmate 205 and 039, who underwent allogeneic HSCT after discontinuing OPDIVO (15 with reduced-intensity conditioning, 2 with myeloablative conditioning). Thirty-five percent (6/17) of patients died from complications of allogeneic HSCT after OPDIVO. Five deaths occurred in the setting of severe or refractory GVHD. Grade 3 or higher acute GVHD was reported in 29% (5/17) of patients. Hyperacute GVHD was reported in 20% (n=2) of patients. A steroid-requiring febrile syndrome, without an identified infectious cause, was reported in 35% (n=6) of patients. Two cases of encephalitis were reported: Grade 3 (n=1) lymphocytic encephalitis without an identified infectious cause, and Grade 3 (n=1) suspected viral encephalitis. Hepatic veno-occlusive disease (VOD) occurred in one patient, who received reduced-intensity conditioned allogeneic HSCT and died of GVHD and multi-organ failure. Other cases of hepatic VOD after reduced-intensity conditioned allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptor blocking antibody before transplantation. Cases of fatal hyperacute GVHD have also been reported. These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT.
Follow patients closely for early evidence of transplant-related complications such as hyperacute GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile syndrome, hepatic VOD, and other immune-mediated adverse reactions, and intervene promptly.
Embryo-Fetal Toxicity
Based on their mechanisms of action, OPDIVO and YERVOY 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 an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO.
Lactation
It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue nursing during treatment with YERVOY and for 3 months following the final dose.
Serious Adverse Reactions
In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (73% and 37%), adverse reactions leading to permanent discontinuation (43% and 14%) or to dosing delays (55% and 28%), and Grade 3 or 4 adverse reactions (72% and 44%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.6%), colitis (10% and 1.6%), and pyrexia (10% and 0.6%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, among all patients (safety population [n=263]), adverse reactions leading to discontinuation (4.2%) or to dosing delays (23%) occurred. The most frequent serious adverse reactions reported in ≥1% of patients were infusion-related reaction, pneumonia, pleural effusion, pyrexia, rash and pneumonitis. Ten patients died from causes other than disease progression, including 6 who died from complications of allogeneic HSCT. Serious adverse reactions occurred in 21% of patients in the safety population (n=263) and 27% of patients in the subset of patients evaluated for efficacy (efficacy population [n=95]).
Common Adverse Reactions
In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (59%), rash (53%), diarrhea (52%), nausea (40%), pyrexia (37%), vomiting (28%), and dyspnea (20%). The most common (≥20%) adverse reactions in the OPDIVO (n=313) arm were fatigue (53%), rash (40%), diarrhea (31%), and nausea (28%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were asthenic conditions (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, among all patients (safety population [n=263]) and the subset of patients in the efficacy population (n=95), respectively, the most common adverse reactions (≥20%) were fatigue (32% and 43%), upper respiratory tract infection (28% and 48%), pyrexia (24% and 35%), diarrhea (23% and 30%), and cough (22% and 35%). In the subset of patients in the efficacy population (n=95), the most common adverse reactions also included rash (31%), musculoskeletal pain (27%), pruritus (25%), nausea (23%), arthralgia (21%), and peripheral neuropathy (21%).
In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).
About the Bristol-Myers Squibb and Ono Pharmaceutical Co., Ltd. Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Ltd (Ono), Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivoglobally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2015 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
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