Donald Trump's criticism of the media has reached Nixonian levels — only Trump isn't doing the name-calling in private. He's doing it right to reporters' faces.
On Tuesday, Trump pointed out ABC News reporter Tom Llamas and called him "a sleaze." Llamas' crime? Asking the presumptive Republican presidential nominee to explain why he had misled people about how much money he'd raised for veterans.
Donald Trump's 'sleaze' attack on reporter hits new level of media animosity - May. 31, 2016
Tuesday, May 31, 2016
Bristol-Myers Squibb to Take Part in Goldman Sachs 37th Annual Global Health Care Conference
From Bristol-Myers Squibb:
Bristol-Myers Squibb to Take Part in Goldman Sachs 37th Annual Global Health Care Conference
Tuesday, May 31, 2016 10:30 am EDT
NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) will take part in Goldman Sachs 37th Annual Global Health Care Conference on Tuesday, June 7, 2016, in Rancho Palos Verdes, CA. Michael Burgess, senior vice president, Exploratory Clinical and Translational Research, will answer questions about the company at 5 p.m. EDT (2 p.m. PDT).
Investors and the general public are invited to listen to a live webcast of the session athttp://investor.bms.com. An archived edition of the session will be available later that day.
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 onLinkedIn, Twitter, YouTube and Facebook.
U.S. FDA Approves Once-daily Jentadueto® XR (linagliptin and metformin hydrochloride extended-release) Tablets for Adults with Type 2 Diabetes (NYSE:LLY)
New formulation of medicines that helps lower blood sugar in type 2 diabetes can be taken once a day
U.S. FDA Approves Once-daily Jentadueto® XR (linagliptin and metformin hydrochloride extended-release) Tablets for Adults with Type 2 Diabetes (NYSE:LLY)
Bank of America, (RED)® and Chef Mario Batali Encourage Friends and Families to Dine Out to Help Support the Fight Against AIDS | Bank of America Newsroom
From June 1 Through June 10, Restaurant Transactions Made by Bank of America Debit Card Customers Enrolled in the Keep the Change® Savings Program Will Trigger Donations That Bring Us One Step Closer to Ending AIDS
Bank of America, (RED)® and Chef Mario Batali Encourage Friends and Families to Dine Out to Help Support the Fight Against AIDS | Bank of America Newsroom
Bank of America, (RED)® and Chef Mario Batali Encourage Friends and Families to Dine Out to Help Support the Fight Against AIDS | Bank of America Newsroom
Russia overtakes Saudi Arabian crude output — RT Business
Russian oil production in March outpaced Saudi Arabia, according to the data from the Russian Federal Statistics Service Rosstat published Monday. Russian producers extracted almost 10.92 million barrels a day compared to 10.12 produced by Saudi Arabia.
Russia overtakes Saudi Arabian crude output — RT Business
Russia overtakes Saudi Arabian crude output — RT Business
Monday, May 30, 2016
Merkel’s TTIP policy is ‘wrong:’ German Vice Chancellor criticizes US-EU free trade deal — RT News
TTIP Hastiness would lead to an unfavorable agreement, German Vice Chancellor and Economy Minister Sigmar Gabriel said, criticizing Chancellor Angela Merkel’s approach to reaching an agreement with the US on harmonizing trade and investment regulations.
Merkel’s TTIP policy is ‘wrong:’ German Vice Chancellor criticizes US-EU free trade deal — RT News
Merkel’s TTIP policy is ‘wrong:’ German Vice Chancellor criticizes US-EU free trade deal — RT News
Sunday, May 29, 2016
3D Printing On Demand With New UPS Service
Whether it is a toy or a hair clip, creating a product is a complicated process involving many people and just as many resources. In the past this meant hiring designers, engineers, a company to do the molding and eventually a manufacturer. If you are a small business with a great idea, you can see how the cost and process can be discouraging. But today, as in almost every industry in the world, digital technology is giving the little guy the same opportunity in manufacturing as large enterprises thanks to 3D printing.
3D Printing On Demand With New UPS Service
3D Printing On Demand With New UPS Service
The Incredible Transformation of Gregory Todd
“Transformation rarely happens accidentally.”
– – from The Incredible Transformation of Gregory Todd
– – from The Incredible Transformation of Gregory Todd
For business leaders, the problem of transformation isn’t about knowing what to do, it’s about know how to apply what we know to what we need to do. Written by a 15-year consultant in the manufacturing industry,The Incredible Transformation of Gregory Todd shows uses the story of a fictional company with real problems to demonstrate how complex (but solvable) business transformation can really be.
The Incredible Transformation of Gregory Todd
As Summer Begins, Be Sure to Make Time for Small Business Events
Small business owners and their employees will be taking some off this Memorial Day weekend. But early June holds some big activity on the events front.
In the first week of June, events in Minneapolis, New York and Chicago are on tap as well as some other events.
As Summer Begins, Be Sure to Make Time for Small Business Events
20 Habits of Successful Entrepreneurs
Successful entrepreneurs come from all different industries and all different backgrounds. But while there isn’t necessarily one prototypical entrepreneur, there are some habits of successful entrepreneurs that can serve as a common link. The list below includes some common habits of successful entrepreneurs.
20 Habits of Successful Entrepreneurs
20 Habits of Successful Entrepreneurs
Die Empty: Unleash Your Best Work Every Day
“How much of your day do you spend doing work that you’ll be proud of later?”
– – From “Die Empty: Unleash Your Best Work Every Day
– – From “Die Empty: Unleash Your Best Work Every Day
There are many books on how to become a success, but only a few on how to be a persistent success. Even fewer cover how to be a persistent success over your lifetime.
Die Empty is that kind of book. A new edition of Henry’s book, asks readers to realistically confront the value they offer to the world through their work, whether they are managing a corporation, delivering interoffice memos, or crafting the next artistic masterpiece. Small Business Trends reviewed an earlier edition of the book some time ago.
Die Empty: Unleash Your Best Work Every Day
Indictment: Hillsboro Man Made $7.9 Million With Oil and Gas Fraud Scheme
Department of Justice
U.S. Attorney’s Office
District of Kansas
FOR IMMEDIATE RELEASE
Tuesday, May 24, 2016
Indictment: Hillsboro Man Made $7.9 Million With Oil and Gas Fraud Scheme
WICHITA, KAN. - A Hillsboro man was indicted Tuesday on charges of carrying out a $7.9 million oil and gas fraud scheme, Acting U.S. Attorney Tom Beall said.
David K. Lawson, 70, Hillsboro, Kan., is charged with one count of wire fraud. The indictment alleges the crime occurred while Lawson was the owner and director of Sonstone Trading, LLC.
Lawson made a deal for Sonstone to sell 90 barrels a day of crude oil to Parnon Gathering, Inc. Crude oil is unrefined oil produced from oil wells. What Sonstone provided to Parnon was in fact not crude oil. It was raw gas oil (RGO), which is a mixture of various refined petroleum products with a very low vapor pressure and a lesser commercial value.
For more information on oil and gas fraud from the Financial Fraud Enforcement Task Force, seewww.stopfraud.gov/oil-gas-fwg.html
If convicted, Lawson faces a penalty of up to 20 years in federal prison, a fine up to $250,000 and restitution. The FBI investigated. Assistant U.S. Attorney Alan Metzger is prosecuting.
OTHER GRAND JURY INDICTMENTS
Drew Alan Reed, 42, El Dorado, Kan., and Timothy Wayne Rosenbaum, Augusta, Kan., are charged with making false statements to a federally licensed firearms dealer when purchasing a gun at Cabela’s, 2447 N. Greenwich in Wichita. The crimes are alleged to have occurred Dec. 3, 2014.
If convicted, they face a penalty of up to five years in federal prison and a fine up to $250,000. The Bureau of Alcohol, Tobacco, Firearms and Explosives investigated. Assistant U.S. Attorney Matt Treaster is prosecuting.
Jonathan C. Wolfinbarger, 54, Wakeeney, Kan., and Steven R. Hansen, 62, Fontana, Calif., are charged with one count of possession with intent to distribute methamphetamine and one count of using the U.S. mails in furtherance of drug trafficking. The crimes are alleged to have occurred in June and July 2015 in Trego County, Kan.
If convicted, they face a penalty of not less than 10 years in federal prison and a fine up to $10 million on the possession count, and up to five years and a fine up to $250,000 on the mail count. The U.S. Postal Inspection Service Investigated. Assistant U.S. Attorney Lanny Welch is prosecuting.
Random Shane Smith, 36, Wichita, Kan., is charged in counts one and two with aggravated sexual abuse, in count three with production of child pornography, in count four with possessing child pornography; and in count five with tampering with a witness. The crimes are alleged to have occurred in 2014, 2015, and 2016 at McConnell Air Force Base.
Smith initially was charged in a criminal complaint filed May 13 in U.S. District Court in Wichita. The indictment adds to the charges in the complaint one count of possession of child pornography and one count of tampering with a witness.
Upon conviction counts one and two carry a penalty of up to life and a fine up to $250,000 on each count; count three carries a penalty of not less than 15 years and not more than 30 years and a fine up to $250,000; count four carries a penalty of up to 10 years and a fine up to $250,000; and count five carries a penalty of up to 20 years and a fine up to $250,000. The FBI and the Air Force OSI investigated. Assistant U.S. Attorney Jason Hart is prosecuting.
Vernon J. Walker, 45, Wichita, Kan., and Tabitha A. Hanchett, 35, Wichita, Kan., are charged in count one with possession with intent to distribute methamphetamine. In addition, Walker is charged in count two with unlawful possession of a firearm in furtherance of drug trafficking, in count three with unlawful possession of a firearm following a felony conviction and in count four with unlawful possession of a firearm by a user of controlled substances. The crimes are alleged to have occurred Jan. 15, 2016, in Sedgwick County, Kan.
Upon conviction, count one carries a penalty of not less than five years and not more than 40 years and a fine up to $5 million; count two carries a penalty of not less than five years and a fine up to $250,000; and counts three and four carry a penalty of up to 10 years and a fine up to $250,000. The Wichita Police Department investigated. Assistant U.S. Attorney Lanny Welch is prosecuting.
Rhonda J. Smith, 47, Wichita, Kan., is charged with two counts of money laundering to conceal funds from a bankruptcy trustee. The crimes are alleged to have occurred in 2013 in Sedgwick County, Kan.
If convicted, she faces a penalty of up to 20 years and a fine up to $500,000 on each count. The FBI investigated. Assistant U.S. Attorney Alan Metzger is prosecuting.
Carlos Alejandro Casas-Pulido, 33, a citizen of Mexico, is charged with one count of unlawful possession of a firearm by a person unlawfully in the United States, and one count of unlawfully re-entering the United States after being deported. The crimes are alleged to have occurred Feb. 23 and Feb. 24, 2016, in Ford County, Kan.
If convicted, he faces a penalty of up 10 years in federal prison and a fine up to $250,000 on the firearm charge, and a penalty of up to two years and a fine up to $250,000 on the re-entry charge. Immigration and Customs Enforcement’s Enforcement and Removal Operations investigated. Assistant U.S. Attorney Brent Anderson is prosecuting.
Fidelina Morales-Escobar, 25, a citizen of Guatemala, is charged in count one with document fraud, in count two with making a false statement on an employment verification form, in count three with misusing a Social Security number, and in count four with aggravated identity theft. The crimes are alleged to have occurred in 2014 and 2016 in Harper County, Kan.
If convicted, she faces a penalty in count one of up to 10 years in federal prison and a fine up to $250,000; in counts two and three a penalty of up to five years and fine up to $250,000; and in count four a mandatory penalty of two years in prison consecutive to the underlying sentence and a fine up to $250,000. Homeland Security Investigations investigated. Assistant U.S. Attorney Brent Anderson is prosecuting.
Angel Adan Prado-Neri, 36, a citizen of Mexico, is charged with one count of unlawfully re-entering the United States after being deported. He was found May 3, 2016, in Sedgwick County, Kan.
If convicted, he faces a maximum penalty of two years in federal prison and a fine up to $250,000. Immigration and Customs Enforcement’s Enforcement Removal Operations investigated. Assistant U.S. Attorney Brent Anderson is prosecuting.
Nicholas A. Moore, 33, who is in custody in Lyon County, is charged with unlawful possession of a firearm following a felony conviction. The crime is alleged to have occurred Jan. 5, 2016, in Emporia, Kan.
If convicted, he faces a penalty of up to 10 years in federal prison and a fine up to $250,000. The Bureau of Alcohol, Tobacco, Firearms and Explosives investigated. Assistant U.S. Attorney Brent Anderson is prosecuting.
In all cases, defendants are presumed innocent until and unless proven guilty. The indictments merely contain allegations of criminal conduct.
Lee's Summit Woman Indicted for Additional Embezzlement Schemes, Identity Theft
Department of Justice
U.S. Attorney’s Office
Western District of Missouri
FOR IMMEDIATE RELEASE
Tuesday, May 24, 2016
Lee's Summit Woman Indicted for Additional Embezzlement Schemes, Identity Theft
KANSAS CITY, Mo. – Tammy Dickinson, United States Attorney for the Western District of Missouri, announced that additional charges have been filed against a Lee’s Summit, Mo., woman who was previously indicted for embezzling more than $300,000 from her employer.
Patricia Webb, 43, of Lee’s Summit, was charged in a 24-count indictment returned by a federal grand jury in Kansas City, Mo. Today’s superseding indictment replaces an indictment returned on March 31, 2016, and includes additional charges related to two more fraud schemes. Webb is in federal custody after having her bond revoked by the court for unrelated fraudulent conduct.
In addition to the scheme to embezzle approximately $302,183 from Black and Veatch, which was charged in the original indictment, today’s superseding indictment charges Webb with a scheme to embezzle $1.2 million from Garmin International, a previous employer, and a scheme to embezzle $7,385 from a healthcare benefits program for Garmin employees.
TriStar Embezzlement Scheme
According to today’s indictment, Webb stole the identity of another employee while she was working at Garmin in order to embezzle $7,385 from TriStar Benefit Administrators, the company which managed Garmin’s healthcare savings accounts.
Webb allegedly created a flexible spending account for another Garmin employee without his knowledge or consent. Webb allegedly submitted a request for reimbursement to TriStar on July 18, 2011. The request was for hospital treatment in the amount of $7,385, the indictment says, and the payment from TriStar was sent to Webb’s bank account.
Today’s indictment charges Webb with one count of wire fraud and one count of aggravated identity theft in relation to this embezzlement scheme.
Garmin Embezzlement Scheme
According to today’s indictment, Webb embezzled $1,224,410 million from Garmin while employed as a senior payroll specialist.
Webb was hired by Garmin on Feb. 28, 2011, and promoted to payroll team leader in August 2011. Webb allegedly caused Garmin to send 16 unauthorized payments to her own business bank account under the corporate name Beauty Within Me from Feb. 24, 2012, to May 30, 2014.
Today’s indictment charges Webb with 16 counts of wire fraud in relation to this embezzlement scheme.
Black and Veatch Embezzlement Scheme
According to today’s indictment, Webb embezzled $302,183 from Black and Veatch while employed as a global payroll manager. Webb was employed by Black and Veatch from January 2015 until March 4, 2016 and earned $90,000 per year.
The indictment alleges that Webb facilitated unauthorized wire transfers and Automated Clearing House transactions (fund transfers, such as direct deposits and business-to-business payments) from the company’s payroll account to her Beauty Within Me business bank account. To conceal her fraud, the indictment says, Webb manipulated the direct deposit information of Black and Veatch employees, who were either based overseas or deceased, to funnel company funds into her own bank account.
Webb allegedly embezzled approximately $302,183 from Black and Veatch in a series of six transfers that ranged from $8,588 to $92,862 over approximately seven months in 2015 and 2016.
During the scheme, according to court documents, Webb made $106,529 in withdrawals and expenditures at casinos; spent $8,986 on travel-related expenses (including airfare and hotels for trips to Bangkok, Thailand, Las Vegas, Nev., and Miami, Fla.; made $14,449 in payments to multiple higher education universities; and made $61,745 in ATM withdrawals.
On March 4, 2016, an accounts manager at Commerce Bank contacted Black and Veatch’s executive management regarding payroll deposits that seemed suspicious. On the same day, Webb was confronted about the suspicious transactions and was suspended without pay.
Today’s indictment charges Webb with six counts of wire fraud in relation to this embezzlement scheme.
Dickinson cautioned that the charges contained in this indictment are simply accusations, and not evidence of guilt. Evidence supporting the charges must be presented to a federal trial jury, whose duty is to determine guilt or innocence.
This case is being prosecuted by Assistant U.S. Attorney Paul S. Becker. It was investigated by the FBI.
Kansas City Man Sentenced to 17 Years In Violent Overland Park Bank Robbery
Department of Justice
U.S. Attorney’s Office
District of Kansas
FOR IMMEDIATE RELEASE
Monday, May 23, 2016
Kansas City Man Sentenced to 17 Years In Violent Overland Park Bank Robbery
KANSAS CITY, KAN. - A Kansas City man who threatened employees with a gun and dragged a woman by her hair during a bank robbery was sentenced Monday to 17 years in federal prison , Acting U.S. Attorney Tom Beall said.
Clifton B. Cloyd, 54, Kansas City, Mo., pleaded guilty to one count of bank robbery and one count of brandishing a firearm during the robbery. On Oct. 29, 2014, he and another man robbed the Bank of America at 9500 Mission in Overland Park, Kan. In his plea, Cloyd admitted:
- He and his accomplice held five bank employees and one customer at gunpoint.
- Cloyd, who was carrying a handgun, grabbed one of the bank employees and pulled her by the hair and scarf to the teller station. He struck her in the face with a handgun.
- Cloyd struck a customer so hard her glasses flew off and she was knocked to the floor.
- Cloyd struck a male bank employee with such force that his head started bleeding.
Co-defendant Steve A. Watts, 55, Kansas City, Mo., is awaiting sentencing.
Beall commended the Overland Park Police Department, the Prairie Village Police Department, the Leawood Police Department, the FBI and Assistant U.S. Attorney David Zabel for their work on the case.
Woman Pleads Guilty To Embezzlement From Real Estate Firm in Salina
Department of Justice
U.S. Attorney’s Office
District of Kansas
FOR IMMEDIATE RELEASE
Monday, May 23, 2016
Woman Pleads Guilty To Embezzlement From Real Estate Firm in Salina
TOPEKA, KAN. - An Ottawa County woman pleaded guilty Tuesday to embezzling from a real estate company in Salina where she worked, Acting U.S. Attorney Tom Beall said.
Janetta Marie Buttery, 42, Bennington, Kan., pleaded guilty to one count of interstate transportation of stolen funds. A criminal information filed in March alleged Buttery embezzled more than $109,000 from her employer.
In her plea, Buttery admitted the crime occurred while she worked as a secretary, bookkeeper and executive assistant at Realty Associates of Salina. Buttery used her access to the company’s credit cards, bank accounts, books and records to divert the company’s funds to herself, her mother and her husband.
Sentencing is set for Aug. 22. She faces a penalty of up to 10 years in federal prison, a fine up to $250,000 and restitution. Beall commended the FBI and Assistant U.S. Attorney Rich Hathaway for their work on the case.
Saturday, May 28, 2016
Friday, May 27, 2016
Free eCommerce Platform GoSpaces Goes Global, Launches in 20 Languages
GoSpaces, a free website builder and ecommerce platform, this week announced on its blog that it is expanding into 38 countries and 20 languages, making it accessible to more than one-third of the world’s population (2.7 billion people) in their native tongue.
The platform will be tailored to each country’s needs regarding use of language and will include local payment gateways, full translations on the backend and, soon to come, auto-currency settings that will help international customers see how much products cost in their local currency.
Free eCommerce Platform GoSpaces Goes Global, Launches in 20 Languages
Verizon reaches deal with 36,000 striking workers - May. 27, 2016
Verizon and its striking labor unions reached a tentative deal on Friday, potentially ending a six-week labor dispute involving 36,000 workers.
U.S. Labor Secretary Thomas Perez announced that Verizon and the unions have reached an "agreement in principle" on a four-year contract. He said he expects Verizon's (VZ, Tech30) striking workers to be "back on the job next week."
Verizon reaches deal with 36,000 striking workers - May. 27, 2016
U.S. Labor Secretary Thomas Perez announced that Verizon and the unions have reached an "agreement in principle" on a four-year contract. He said he expects Verizon's (VZ, Tech30) striking workers to be "back on the job next week."
Verizon reaches deal with 36,000 striking workers - May. 27, 2016
UnitedHealth Group - National Military Family Association, Give an Hour and United Health Foundation to Launch Initiative Supporting Military Spouse Mental Health Professionals
- United Health Foundation donates $200,000 to fund the Military Spouse Mental Health Profession Network, which will strengthen resources available to military spouses pursuing careers in behavioral health
- Capitol Hill forum brings together experts to discuss shortage of mental health professionals in the military community
UnitedHealth Group - National Military Family Association, Give an Hour and United Health Foundation to Launch Initiative Supporting Military Spouse Mental Health Professionals
Still anemic: U.S. growth picks up to only 0.8% - May. 27, 2016
America's economy grew a little more at the beginning of the year than first thought, but it's still not much to celebrate.
U.S. economic growth between January and March was 0.8% compared to the same time frame a year ago. That's better than the initial estimate of 0.5%, which came in April, but still pretty sluggish.
Still anemic: U.S. growth picks up to only 0.8% - May. 27, 2016
U.S. economic growth between January and March was 0.8% compared to the same time frame a year ago. That's better than the initial estimate of 0.5%, which came in April, but still pretty sluggish.
Still anemic: U.S. growth picks up to only 0.8% - May. 27, 2016
Brexit divides English dairy farming family as EU referendum nears - May. 27, 2016
The green pastures of Dauntley Vale in the west of England offer an unlikely backdrop to a Brexit battle royale.
But mention Britain's referendum on whether to remain a member of the European Union in the Cryer household and things get heated.
Brexit divides English dairy farming family as EU referendum nears - May. 27, 2016
But mention Britain's referendum on whether to remain a member of the European Union in the Cryer household and things get heated.
Brexit divides English dairy farming family as EU referendum nears - May. 27, 2016
Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union
From #Merck:
Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union
Friday, May 27, 2016 7:46 am EDT
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER™ (elbasvir and grazoprevir), an investigational, once-daily, fixed-dose combination tablet for the treatment of chronic hepatitis C virus (HCV) in adult patients. The CHMP positive opinion will be reviewed by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. Merck anticipates that the European Commission decision will be made in mid-2016. The company continues to work to achieve manufacturing readiness to supply the EU market, with product launches estimated to begin in the fourth quarter of 2016 or the first quarter of 2017.
The U.S. Food and Drug Administration and Health Canada approved ZEPATIER 50mg/100mg tablets in January 2016. In the United States, ZEPATIER is indicated for the treatment of adult patients with chronic HCV genotype 1 or 4 infection, with or without ribavirin (RBV).
“We are pleased with the CHMP’s positive opinion recommending the marketing authorization of ZEPATIER in the European Union, which marks an important step forward in the European regulatory process,” said Dr. Roy Baynes, senior vice president and head of clinical development, Merck Research Laboratories. “Our application was based on the findings from a broad clinical development program evaluating the efficacy and safety of ZEPATIER across diverse populations of patients with chronic hepatitis C, including patients with compensated cirrhosis and those with stage 4 or 5 chronic kidney disease.”
Selected Safety Information about ZEPATIER (elbasvir and grazoprevir)
ZEPATIER is not for use in patients with moderate or severe hepatic impairment (Child Pugh B or C). ZEPATIER is also not for use with organic anion transporting polypeptides 1B1/3 (OATP1B1/3) inhibitors (e.g., atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cyclosporine), strong cytochrome P450 3A (CYP3A) inducers (e.g., carbamazepine, phenytoin, rifampin, St. John’s Wort), and efavirenz. If ZEPATIER is administered with RBV, healthcare professionals should refer to the prescribing information for RBV as the contraindications, warnings and precautions, adverse reactions and dosing for RBV also apply to this combination regimen.
Elevations of alanine transaminase (ALT) to greater than 5 times the upper limit of normal (ULN) occurred in 1% of subjects, generally at or after treatment week 8. These late ALT elevations were typically asymptomatic and most resolved with ongoing or completion of therapy. Healthcare professionals should perform hepatic lab testing on patients prior to therapy, at treatment week 8, and as clinically indicated. For patients receiving 16 weeks of therapy, additional hepatic lab testing should be performed at treatment week 12.
Patients should be instructed to consult their healthcare professional without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discolored feces. Healthcare providers should consider discontinuing ZEPATIER if ALT levels remain persistently greater than 10 times ULN. ZEPATIER should be discontinued if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalized ratio.
The concomitant use of ZEPATIER with certain drugs may lead to adverse reactions or reduced therapeutic effect due to drug interactions. Certain strong CYP3A inhibitors may increase the plasma concentration of ZEPATIER, leading to possibly clinically significant adverse reactions. Moderate CYP3A inducers may decrease the plasma concentration of ZEPATIER, leading to reduced therapeutic effect and possible development of resistance. Coadministration of ZEPATIER with these drugs is not recommended. Physicians should consult the Prescribing Information for potential drug interactions.
In subjects receiving ZEPATIER for 12 weeks, the most commonly reported adverse reactions of all intensity (greater than or equal to 5% in placebo-controlled trials) were fatigue, headache and nausea. In subjects receiving ZEPATIER with RBV for 16 weeks, the most commonly reported adverse reactions of moderate or severe intensity (greater than or equal to 5%) were anemia and headache.
About ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg Tablets
ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated with or without ribavirin for treatment of chronic HCV genotype 1 or 4 infection in adults. ZEPATIER is a single tablet taken once daily. The recommended dosing is 12 or 16 weeks with or without RBV, depending on HCV genotype, prior treatment history and, for patients with genotype 1a infection, presence of certain baseline NS5A resistance-associated polymorphisms. See Prescribing Information for ZEPATIER for specific dosage regimens and durations. Refer to RBV prescribing information for RBV dosing and dosage modifications when ZEPATIER is given with RBV. To determine dosage regimen and duration of ZEPATIER for genotype 1a patients, testing for the presence of virus with one or more baseline NS5A resistance-associated polymorphisms at positions 28, 30, 31, or 93 is recommended prior to initiating treatment.
Merck’s Commitment to HCV
For more than 30 years, Merck has been at the forefront of the response to the HCV epidemic. Merck employees are dedicated to applying their scientific expertise, resources and global reach to develop and deliver innovative healthcare solutions to support people living with chronic HCV worldwide.
About Merck
For 125 years, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside 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 health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. 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 health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’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 the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company 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 the company’s 2015 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 ZEPATIER (elbasvir and grazoprevir) at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf and the Patient Information for ZEPATIER at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_ppi.pdf
Amgen Receives Positive CHMP Opinion To Extend Indication Of Kyprolis® (Carfilzomib) For The Treatment Of Relapsed Multiple Myeloma
Pivotal Head-to-Head ENDEAVOR Study Shows Kyprolis Plus Dexamethasone Doubled Progression-Free Survival Compared to Velcade® (Bortezomib) and Dexamethasone
Amgen - Investors - RSS Content
Amgen - Investors - RSS Content
Fashion Brand Feedback Provides Insights to Fashion Retailers
The fashion industry’s growth has been enviable. When dissected, the remarkable growth points at the factors below:
- Customer feedback in fashion commerce
- Mobile commerce
- Millennials making up the target audience
- Harnessing big data
Fashion Brand Feedback Provides Insights to Fashion Retailers
Kyprolis® (Carfilzomib) Demonstrates Economic Value In Relapsed Or Refractory Multiple Myeloma Manuscript Published In "Journal of Medical Economics"
Analysis Based on Head-to-Head Trial Shows Kyprolis With Lenalidomide and Dexamethasone Offers Substantial Value Over Previous Standard of Care in Relapsed or Refractory Multiple Myeloma
Amgen - Investors - RSS Content
Amgen - Investors - RSS Content
UnitedHealth Group - UnitedHealthcare Donates $50,000 to Support Health and Wellness Programs in Indiana
- Grants awarded to community-based organizations that help low-income Hoosiers live healthier lives
UnitedHealth Group - UnitedHealthcare Donates $50,000 to Support Health and Wellness Programs in Indiana
How to Define Value: Patient Outcomes or Modeling?
From Bristol-Myers Squibb:
How to Define Value: Patient Outcomes or Modeling?
Bristol-Myers Squibb’s Response to ICER’s Report,“Treatment Options for Relapsed or Refractory Multiple Myeloma: Effectiveness, Value, and Value-based Price Benchmarks”
Thursday, May 26, 2016 10:55 am EDT
At Bristol-Myers Squibb, we are committed to putting patients and their families first in their fight against serious diseases. Through our pioneering Immuno-Oncology research, we are transforming the way cancer is treated and expanding our approach to provide meaningful, long-term outcomes. It is essential that the healthcare community continues to foster an environment of innovation in order to fulfill the promise of Immuno-Oncology therapies: longer survival and enhanced quality of life for patients and their families. This is particularly important in cancers with a high unmet need, such as relapsed or refractory multiple myeloma.
Today only 49% of multiple myeloma patients survive for five or more years after diagnosis. Many of these patients experience a cycle of remission and relapse, and once a patient first relapses, their prognosis worsens with progressively faster relapses through each subsequent line of therapy. That is why we have focused on leveraging our Immuno-Oncology science to bring Empliciti™ (elotuzumab) to multiple myeloma patients most in need of new options. Empliciti in combination with Revlimid®(lenalidomide) and dexamethasone provides multiple myeloma patients who do not respond to, or relapse on their current therapies, a fundamentally different treatment approach by directly activating their own immune systems to fight the disease.
Empliciti has demonstrated clinical effectiveness for patients fighting multiple myeloma, and its breakthrough therapy designation with the U.S. Food and Drug Administration speaks to the unmet need it was designed to help address. However, when discussingEmpliciti’s value in “Treatment Options for Relapsed or Refractory Multiple Myeloma: Effectiveness, Value, and Value-based Price Benchmarks,” the Institute for Clinical and Economic Review (ICER) fails to recognize the patient perspective and the value Emplicitiand other novel therapies may bring to people with relapsed or refractory multiple myeloma and the healthcare system that serves them.
In the spirit of putting patient needs first, we fundamentally disagree with ICER’s approach to value assessment, which led to the questionable conclusions outlined in its report. Our view is based on the following points:
- The report does not reflect the true value of health outcomes in cancer care: With the application of cost-effectiveness thresholds, ICER has imposed arbitrary barriers to patient access. Well-known limitations of quality-adjusted life years (QALY) as a measure of benefit might result in the undervaluing of treatment benefits in older populations—a salient point in multiple myeloma given a median age at diagnosis of 69. Thus, drawing conclusions using ICER’s cost-effectiveness threshold approach risks denying patients access to life-saving cancer treatments that are now the standard of care.
- It is based on uncertainties in comparative effectiveness research: The ICER model exhibits a number of limitations that even the organization itself acknowledges. These include (i) inaccurate and incomplete assessments of costs and cost savings for each therapy, (ii) use of immature data that does not capture potential changes in efficacy that could occur after longer-term patient follow-up, (iii) differences between clinical trials and real-world dosing regimens, (iv) availability of evidence for all relevant treatments and (v) uncertainty of the point estimates. Moreover, ICER’s own analyses have produced highly inconsistent results between the draft and revised versions of the report, thus illustrating the uncertainty of these results.
- It does not adhere to established Health Technology Assessment best practices: Health Technology Assessments should be based on a clear, transparent, sophisticated and differentiated view of what constitutes value. The assessments also should include early and ongoing dialogue with the patients and reflect comprehensive understanding of the disease management benefits as well as the indirect benefits provided.
While assessments of cost-effectiveness may prove useful in comparing treatments, they have significant limitations, and the lack of available mature data sources preclude the drawing of valid conclusions. Therefore, these assessments should not be used for decision-making that determines access to innovative medicines. As a company focused on improving the lives of patients worldwide, Bristol-Myers Squibb actively encourages the healthcare community to join us in advocating for keeping treatment decisions where they ultimately and rightfully belong―between a patient and his or her healthcare team.
INDICATION
EMPLICITI™ (elotuzumab) is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.
IMPORTANT SAFETY INFORMATION
Infusion Reactions
- EMPLICITI can cause infusion reactions. Common symptoms include fever, chills, and hypertension. Bradycardia and hypotension also developed during infusions. In the trial, 5% of patients required interruption of the administration of EMPLICITI for a median of 25 minutes due to infusion reactions, and 1% of patients discontinued due to infusion reactions. Of the patients who experienced an infusion reaction, 70% (23/33) had them during the first dose. If a Grade 2 or higher infusion reaction occurs, interrupt the EMPLICITI infusion and institute appropriate medical and supportive measures. If the infusion reaction recurs, stop the EMPLICITI infusion and do not restart it on that day. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment.
- Premedicate with dexamethasone, H1 Blocker, H2 Blocker, and acetaminophen prior to infusing with EMPLICITI.
Infections
- In a clinical trial of patients with multiple myeloma (N=635), infections were reported in 81.4% of patients in the EMPLICITI with lenalidomide/dexamethasone arm (ERd) and 74.4% in the lenalidomide/dexamethasone arm (Rd). Grade 3-4 infections were 28% (ERd) and 24.3% (Rd). Opportunistic infections were reported in 22% (ERd) and 12.9% (Rd). Fungal infections were 9.7% (ERd) and 5.4% (Rd). Herpes zoster was 13.5% (ERd) and 6.9% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5% (ERd) and 2.2% (Rd). Monitor patients for development of infections and treat promptly.
Second Primary Malignancies
- In a clinical trial of patients with multiple myeloma (N=635), invasive second primary malignancies (SPM) were 9.1% (ERd) and 5.7% (Rd). The rate of hematologic malignancies were the same between ERd and Rd treatment arms (1.6%). Solid tumors were reported in 3.5% (ERd) and 2.2% (Rd). Skin cancer was reported in 4.4% (ERd) and 2.8% (Rd). Monitor patients for the development of SPMs.
Hepatotoxicity
- Elevations in liver enzymes (AST/ALT greater than 3 times the upper limit, total bilirubin greater than 2 times the upper limit, and alkaline phosphatase less than 2 times the upper limit) consistent with hepatotoxicity were 2.5% (ERd) and 0.6% (Rd). Two patients experiencing hepatotoxicity discontinued treatment; however, 6 out of 8 patients had resolution and continued treatment. Monitor liver enzymes periodically. Stop EMPLICITI upon Grade 3 or higher elevation of liver enzymes. After return to baseline values, continuation of treatment may be considered.
Interference with Determination of Complete Response
- EMPLICITI is a humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.
Pregnancy/Females and Males of Reproductive Potential
- There are no studies with EMPLICITI with pregnant women to inform any drug associated risks.
- There is a risk of fetal harm, including severe life-threatening human birth defects associated with lenalidomide and it is contraindicated for use in pregnancy. Refer to the lenalidomide full prescribing information for requirements regarding contraception and the prohibitions against blood and/or sperm donation due to presence and transmission in blood and/or semen and for additional information.
Adverse Reactions
- Infusion reactions were reported in approximately 10% of patients treated with EMPLICITI with lenalidomide and dexamethasone. All reports of infusion reaction were Grade 3 or lower. Grade 3 infusion reactions occurred in 1% of patients.
- Serious adverse reactions were 65.4% (ERd) and 56.5% (Rd). The most frequent serious adverse reactions in the ERd arm compared to the Rd arm were: pneumonia (15.4%, 11%), pyrexia (6.9%, 4.7%), respiratory tract infection (3.1%, 1.3%), anemia (2.8%, 1.9%), pulmonary embolism (3.1%, 2.5%), and acute renal failure (2.5%, 1.9%).
- The most common adverse reactions in ERd and Rd, respectively (>20%) were fatigue (61.6%, 51.7%), diarrhea (46.9%, 36.0%), pyrexia (37.4%, 24.6%), constipation (35.5%, 27.1%), cough (34.3%, 18.9%), peripheral neuropathy (26.7%, 20.8%), nasopharyngitis (24.5%, 19.2%), upper respiratory tract infection (22.6%, 17.4%), decreased appetite (20.8%, 12.6%), and pneumonia (20.1%, 14.2%).
Please see the full Prescribing Information for Empliciti.
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Endnotes
Empliciti is a trademark of Bristol-Myers Squibb Company.
Revlimid is a registered trademark of Celgene Corporation. All other trademarks are property of their respective owners.
How to Manage a Handmade Business of One
At the start of your business, you are doing everything yourself. As you grow, may decide to hire people to help you act on and manage certain tasks. But not everyone wants to hire help. Some people enjoy making products and managing a business on their own. They want to be a handmade business of one and “stay small and keep it all.”
Whichever camp you fall into, if you happen to be a handmade business of one, there are some specific things you’ll need to do on a regular basis to build a profitable and sustainable venture. Here are 11 of them.
How to Manage a Handmade Business of One
Thursday, May 26, 2016
Small Business Retirement Plans On The Wane Study Shows
The number of small businesses offering their employees a retirement plan has dropped by almost 50 percent.
According to Capital One’s Spark Business Barometer, political uncertainty and poor retail conditions have forced a vast number of small businesses to scale back hiring plans — with just 26 percent of owners saying they plan to take on new staff in the next six months.
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Small Business Retirement Plans On The Wane Study Shows
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