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Monday, September 30, 2013

Payroll Card: An Alternative for Businesses and Employees

Payroll Card: An Alternative for Businesses and Employees

Merck Animal Health’s HomeAgain® Announces Finalists for Hero of the Year Award; Voting Begins

Merck Press Release:

Merck Animal Health’s HomeAgain® Announces Finalists for Hero of the Year Award; Voting Begins

Monday, September 30, 2013 8:00 am EDT

Public Company Information:

NYSE:
MRK
HomeAgain® Pet Recovery Service, a division of Merck Animal Health, today announced the five finalists for the HomeAgain Hero of the Year Award. Chosen by an esteemed panel of judges from the animal welfare community, each finalist was identified as having outstanding dedication to supporting the health and well-being of companion animals.
“We received hundreds of nominations detailing countless ways people are contributing to and making a difference in animal well-being,” said Linda Block, marketing director for HomeAgain. “These stories are a true testament to the amazing character of the people that make up the companion animal community. We are proud to be able to recognize these unsung heroes.”
The award winner will be determined by a public vote, which will run through October 21, 2013. Everyone is encouraged to read about the finalists and vote for their favorite onHomeAgainHeroes.com, as well as share these truly remarkable stories with friends, family and colleagues.
About the Finalists
  • Jeff Bennett, a volunteer pilot with Pilots N Paws, has used his time, money and personal airplane to transport nearly 2,000 animals from kill facilities to shelters and rescue groups in other areas. Because of his dedication of time and resources, these animals  have an opportunity to be placed in a permanent home, receive necessary medical care or become a service animal.
  • Joyce Gerardi, DVM, is the founder of Kindred-Canines In Motion Inc. and offers free veterinary services, including the latest in canine arthritis treatment, to companion and service dogs to keep them in motion and working with people with disabilities.  
  • Jennifer Leary is a Philadelphia Fire Fighter, Red Cross Emergency Responder and founder of Red Paw Emergency ReliefRed Paw works in conjunction with first responders to provide aid and services to pets involved in a fire or other disasters. The organization has responded to nearly 200 calls within the first year of service.
  • Vicki Phillips is a board member for Mid-Atlantic English Springer Spaniel Rescue. She grooms, shelters, shuttles, cares for and helps find permanent homes for countless dogs endangered by human mistreatment and natural disasters, such as Hurricanes Katrina and Sandy.
  • Theresa Strader, founder of National Mill Dog Rescue, rescues, rehabilitates and finds homes for dogs rescued from puppy mills. She also educates the general public about the cruel realities of the commercial dog breeding industry, and has rescued nearly 8,000 dogs since its inception.
In honor of these individuals’ efforts, HomeAgain will make a $10,000 donation in the name of the HomeAgain Hero of the Year award winner, as well as a donation in the name of each of the four finalists. Those donations will be made to Petfinder FoundationWinn Feline Foundation,Assistance Dogs International or Morris Animal Foundation.
About HomeAgain
The national HomeAgain Pet Recovery Service reunites more than 10,000 lost pets with their families each month and has brought more than one million lost pets home. HomeAgain is more than just a microchip. Once enrolled, a pet's microchip is registered in the HomeAgain National Pet Recovery Database for its lifetime and members receive additional services such as Lost Pet Posters and Alerts, a 24/7 Pet Emergency Hotline and travel reimbursement of up to $500 for dogs or cats found more than 500 miles from home. HomeAgain memberships are renewable annually for a fee of $17.99.  For more information, visit www.homeagain.com.
About Merck Animal Health
Today's Merck is a global healthcare leader working to help the world be well. Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck. Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com.

Lilly to host investment community meeting at its Indianapolis headquarters on Thursday, October 3, 2013 (NYSE:LLY)

Lilly to host investment community meeting at its Indianapolis headquarters on Thursday, October 3, 2013 (NYSE:LLY)

Verizon Earns Top 100 Spot in 2013 InformationWeek 500

Verizon Earns Top 100 Spot in 2013 InformationWeek 500

Shantanu Narayen Elected To Pfizer's Board Of Directors

Pfizer Press Release:

Shantanu Narayen Elected To Pfizer's Board Of Directors

Monday, September 30, 2013 11:00 am EDT

Dateline:

NEW YORK

Public Company Information:

NYSE:
PFE
US7170811035
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. today announced the election of Shantanu Narayen to its Board of Directors, effective September 27, 2013. Mr. Narayen also was appointed to the Corporate Governance and Science and Technology Committees of Pfizer’s Board.
Mr. Narayen, 50, is the President and Chief Executive Officer (CEO) of Adobe Systems Incorporated and serves on Adobe’s Board of Directors. Prior to his appointment as CEO in December 2007, he held various leadership positions at Adobe, including President and Chief Operating Officer, Executive Vice President of Worldwide Products, Senior Vice President of Product Development, and Vice President and General Manager of the Engineering Technology Group.
Mr. Narayen is a member of the U.S. President's Management Advisory Board, established in 2010 to provide advice on how to implement best business practices, including the application of technology, on matters related to federal government management and operation. He is a director of Dell Inc., serves on the Advisory Board of the Haas School of Business, University of California at Berkeley, and is President of the board of the Adobe Foundation, which funds philanthropic initiatives around the world. -2-
“We are pleased to welcome Shantanu Narayen to Pfizer’s Board of Directors. He brings both leadership experience and a strong technology background to Pfizer’s Board and will be an excellent asset to the company,” stated Ian Read, Pfizer’s chairman and chief executive officer. “The addition of Shantanu Narayen to our Board helps ensure that Pfizer will continue to benefit from a diversity of experience.”
Mr. Narayen received a bachelor's degree in electronics engineering from Osmania University in India, a master's degree in computer science from Bowling Green State University and a master's degree in business administration from the Haas School of Business.

Alcoa Foundation Announces US$1.25 Million Global Internship Program for Unemployed Youth

Alcoa Press Release:

September 30, 2013
Alcoa Foundation Announces US$1.25 Million Global Internship Program for Unemployed Youth
NEW YORK--(BUSINESS WIRE)--Today, Alcoa Foundation announced a US$1.25 million internship program for 500 students in eight countries over the next two years. The program is a community-wide initiative involving several manufacturing companies and will be managed by the Institute of International Education (IIE). The goal is to provide unemployed youth with the experience to start a successful career in manufacturing.

The announcement was made at Alcoa’s 125th anniversary celebration in Pittsburgh, PA, by Chairman and CEO Klaus Kleinfeld, who stressed the importance of youth receiving work-related experience and information about post-secondary education and technical training options.

“To educate and train young people well is fundamental for allowing them to create their own future. This is critically important for the individual as much as it strengthens the communities they live in. We are proud to work with our nonprofit partners around the world in bringing these opportunities to our Alcoa locations and offer attractive options for the youth to explore careers in manufacturing and engineering.”

Alcoa (NYSE: AA) leadership in Australia, Brazil, Canada, France, Jamaica, Spain, United Kingdom and the United States will select nonprofit organizations with job readiness programs to financially support, that will place students in internships with local manufacturers.

“This program will provide student interns with valuable hands-on learning experience and teach the skills necessary for a career in advanced manufacturing,” said Tricia Napor, Vice President, Alcoa Foundation. “In addition, local nonprofits will work with Alcoa locations to arrange volunteers to mentor interns, share manufacturing expertise, and host locations visits for all interns in the program.”

Each nonprofit will receive on average US$125,000 to deploy a paid-internship program in the community.

About Alcoa Foundation

Alcoa Foundation is one of the largest corporate foundations in the U.S., with assets of approximately $460 million. Founded 60 years ago, Alcoa Foundation has invested more than $570 million since 1952. In 2012, Alcoa Foundation contributed more than $21 million to nonprofit organizations throughout the world, building innovative partnerships to improve the environment and educate tomorrow’s leaders for careers in manufacturing and engineering. The work of Alcoa Foundation is further enhanced by Alcoa’s thousands of employee volunteers who share their talents and time to make a difference in the communities where Alcoa operates. Through the Company’s signature Month of Service program, in 2012, a record 60 percent of Alcoa employees took part in more than 1,050 events across 24 countries, benefiting more than 450,000 people and 2,050 nonprofit organizations. For more information, visit alcoafoundation.com and follow @AlcoaFoundation on Twitter.

About Alcoa

Alcoa is the world’s leading producer of primary and fabricated aluminum, as well as the world’s largest miner of bauxite and refiner of alumina. In addition to inventing the modern-day aluminum industry, Alcoa innovation has been behind major milestones in the aerospace, automotive, packaging, building and construction, commercial transportation, consumer electronics and industrial markets over the past 125 years. Among the solutions Alcoa markets are flat-rolled products, hard alloy extrusions, and forgings, as well as Alcoa® wheels, fastening systems, precision and investment castings, and building systems in addition to its expertise in other light metals such as titanium and nickel-based super alloys. Sustainability is an integral part of Alcoa’s operating practices and the product design and engineering it provides to customers. Alcoa has been a member of the Dow Jones Sustainability Index for 11 consecutive years and approximately 75 percent of all of the aluminum ever produced since 1888 is still in active use today. Alcoa employs approximately 61,000 people in 30 countries across the world. For more information, visit www.alcoa.com, follow @Alcoa on Twitter at www.twitter.com/Alcoa and follow Alcoa on Facebook atwww.facebook.com/Alcoa.

About the Institute of International Education

The Institute of International Education is a world leader in the international exchange of people and ideas. An independent, not-for-profit organization founded in 1919, IIE has a network of 19 offices and affiliates worldwide and over 1,200 member institutions. IIE designs and implements programs of study and training for students, educators, young professionals and trainees from all sectors with funding from government agencies, foundations, and corporations. IIE also conducts policy research and program evaluations, and provides advising and counseling on international education and opportunities abroad. For more information, visitwww.iie.org.

Obamacare exchanges face delays, technical glitches - Sep. 30, 2013

The Obamacare insurance exchanges open for business on Tuesday ... sorta.


Obamacare exchanges face delays, technical glitches - Sep. 30, 2013

Advil® Becomes Official Pain Reliever of the National Hockey League and the 30 Team Athletic Trainers

Pfizer Press Release:

Advil® Becomes Official Pain Reliever of the National Hockey League and the 30 Team Athletic Trainers

Monday, September 30, 2013 10:00 am EDT

Dateline:

NEW YORK

Public Company Information:

NYSE:
PFE
US7170811035
NEW YORK--(BUSINESS WIRE)--Pfizer Consumer Healthcare, a unit of Pfizer, Inc. (NYSE:PFE) and the maker of Advil®, the #1 selling over-the-counter pain reliever in the United States, and the National Hockey League (NHL) today announced Advil® is an Official Partner and the Official Pain Reliever of the NHL® and the 30 NHL athletic trainers in North America for the 2013-14 season. Under the agreement, Advil® is also an Official Partner and the Official Pain Reliever of the 2014 Bridgestone NHL Winter Classic® and the 2014 Coors Light NHL Stadium Series™.
As an official partner of the NHL, Advil® will receive significant media exposure, including prominent in-ice brand position, camera-visible dasherboards and placement at accompanying fan festivals of League tent-pole events. Advil® will also benefit from custom integration throughout all NHL-controlled media properties including NHL.com, NHL Network™ and NHL Social™, in addition to the League’s U.S. national broadcast partner, NBC Sports Group.
“The Advil® brand has joined the NHL family at a very exciting time,” said Dave Lehanski, Senior Vice President, Integrated Sales, NHL. “With the most ambitious series of big events in League history planned for this season – six outdoor games over 61 days – we are delivering unprecedented fan engagement while offering our partners more opportunities to activate than ever before.”
"The NHL deal provides a terrific platform for driving the launch of our new, fast acting Advil® line,” said Brian Groves, U.S. Chief Marketing Officer at Pfizer Consumer Healthcare. “Advil® is built to be as fast as it is tough. We see the players and the League as embodying the fast acting Advil® promise of fast recovery from tough pain."
About Advil®
Advil® is the number-one selling over-the-counter pain reliever in the United States. Advil® provides relief from multiple aches and pains -- including headaches, backaches, muscle aches and minor arthritis pains. The Advil® line of products also includes Children’s Advil®, Advil® PM, Advil® Cold & Sinus, Advil® Allergy Sinus, and Advil® Congestion Relief and the new fast acting Advil®, available in stores now. Use as directed.
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.
About the NHL
The National Hockey League, founded in 1917, is the second-oldest of the four major professional team sports leagues in North America. Today, the NHL® consists of 30 Member Clubs, each reflecting the League’s international makeup, with players from more than 20 countries represented on team rosters. According to a Simmons Market Research study, NHL fans are younger, more educated, more affluent, and access content through digital means more than any other sport. The NHL entertains more than 250 million fans each season in-arena and through its partners in national television (NBCSN, NBC, TSN, CBC, RDS, RIS, and NHL Network™) and radio (NHL Radio™, Sirius XM Radio). Through the NHL Foundation, the League’s charitable arm, the NHL raises money and awareness for Hockey Fights Cancer™ and NHL Youth Development, and supports the charitable efforts of NHL players. For more information on the NHL, log on to NHL.com.

Global Study Reveals Online Shoppers Want More Convenience - UPS Pressroom

Global Study Reveals Online Shoppers Want More Convenience - UPS Pressroom

Global Study Reveals Online Shoppers Want More Convenience - UPS Pressroom

Global Study Reveals Online Shoppers Want More Convenience - UPS Pressroom

Crest® + Oral-B® Relaunches Pros in the Profession® Awards Program

News Release:

Crest® + Oral-B® Relaunches Pros in the Profession® Awards Program
Four standout dental hygienists to be honored for their devotion to oral health
CINCINNATI--(BUSINESS WIRE)--Sep. 30, 2013-- Crest® + Oral-B® continues to recognize Registered Dental Hygienists (RDHs) who go above and beyond the call of duty with the third year of the Pros in the Profession® awards program. These awards acknowledge the pivotal role hygienists play in their patients’ lives in addition to their unwavering personal commitment to promoting good oral health.
“We have seen extraordinary entries over the past several years, which is why we must continue to honor those hygienists whose passion shine through in their everyday work,” said John ScarchilliScientific Communications for P&G Oral Care. “These individuals dedicate countless hours to furthering the oral health cause, so we are pleased to be able to applaud them publicly.”
Throughout the year, Crest + Oral-B will reward four exceptional RDHs who consistently display dedication towards both their patients and their craft. Winners will receive:
  • An all-expense paid trip to visit the Procter & Gamble German Innovation Center at Kronberg, Germany
  • $1,000 USD monetary prize
  • A recognition plaque
  • Recognition in dental periodicals and announcements on Crest + Oral-B for Dental Professionals Facebook page and Dentalcare.com.
From September 2013 until March 2014, nominations can be submitted via a nomination tab on the Crest + Oral-B for Dental Professionals Facebook page. For the first time in the program, hygienists may nominate themselves for this coveted honor. Nominations can also be submitted by dentists, fellow hygienists, dental assistants, professional colleagues and collegiate colleagues, conveying why their nominee is a Pro in the Profession. Additionally, Crest + Oral-B will be present at dental conventions throughout year where applications can be submitted on-site.
In order to be considered for the program, nominees must meet the following criteria:
  • RDHs with two years or more of clinical/professional experience after graduation from dental hygiene school.
  • RDHs who participate in community service.
  • RDHs with examples of work that goes above and beyond the call of duty.
“It is an honor, as a previous recipient of the award, that Crest + Oral-B has decided to continue rewarding those in our profession,” said Ann Benson Ross, Pros in the Profession winner. “I’ve learned an immense amount from the experience and have been afforded so many new opportunities, so I encourage all to take part as I know so many of us out there deserve the honor.”
To learn more about Pros in the Profession, including how to nominate yourself or a Pro for consideration, along with rules and regulations, please visit facebook.com/professionalcrestoralb or prosintheprofession.com. For information about Crest + Oral-B products and resources, visit the updated dentalcare.com website.
About Crest
A trusted leader in oral health, Crest was the first oral care brand to secure the ADA Seal of Acceptance for a clinically proven fluoride toothpaste. Since first introducing fluoride toothpaste 54 years ago, it is estimated that Crest has helped prevent more than half a billion cavities in the United States. Headquartered in Cincinnati, OH, Crest is owned and distributed by Procter & Gamble.
About Oral-B
Oral-B is the worldwide leader in the over $5 billion brushing market. Part of the Procter & Gamble Company, the brand includes manual and electric toothbrushes for children and adults, oral irrigators and interdental products, such as dental floss. Oral-B manual toothbrushes are used by more dentists than any other brand in the U.S. and many international markets.
About Procter & Gamble
P&G serves approximately 4.8 billion people around the world with its brands. The Company has one of the strongest portfolios of trusted, quality, leadership brands, including Ace®, Always®, Ambi Pur®, Ariel®, Bounty®, Charmin®, Crest®, Dawn®, Downy®, Duracell®, Fairy®, Febreze®, Fusion®, Gain®, Gillette®, Head & Shoulders®, Iams®, Lenor®, Mach3®, Olay®, Oral-B®, Pampers®, Pantene®, Prestobarba®, SK-II®, Tide®, Vicks®, Wella®, and Whisper®. The P&G community includes operations in approximately 70 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.
Source: Procter & Gamble

Should You Allow Damage Insurance in Place of a Security Deposit?

Should You Allow Damage Insurance in Place of a Security Deposit?

GlaxoSmithKline reaches agreement with Aspen to divest thrombosis brands and related manufacturing site for £0.7 billion

GSK Press Release:

GlaxoSmithKline reaches agreement with Aspen to divest thrombosis brands and related manufacturing site for £0.7 billion

Issued: Monday 30 September 2013, London UK – LSE Announcement
GlaxoSmithKline (LSE:GSK) today announced it has reached agreement to sell its thrombosis brands, Arixtra® and Fraxiparine®, and the Notre-Dame de Bondeville (NDB) manufacturing site to The Aspen Group (Aspen), the South African pharmaceuticals company, for £0.7 billion in cash, of which £0.1 billion relates to inventory. The agreement is a further example of GSK’s commitment to increase focus on products with the most growth potential and the delivery of its late-stage pipeline. 
The net cash proceeds from the transaction after tax and transaction costs are expected to be approximately £0.6 billion. The proceeds will be used for general corporate purposes. The net profit on disposal will be excluded from core operating profit and core EPS in 2013. 
Aspen will acquire global rights to the Arixtra® and Fraxiparine® brands (excluding China, India and Pakistan) and certain dedicated commercial employees, along with the related NDB manufacturing site and the majority of employees at NDB in France. In Indonesia, GSK will continue to distribute and market the brands under licence from Aspen. Subject to regulatory approvals, it is expected that the majority of commercial operations will transfer to Aspen by the end of the year with the remainder, along with the NDB site, to follow in the first half of 2014. Total sales of these products in the territories subject to this transaction were £177 million in the first half of 2013.
David Redfern, Chief Strategy Officer, GSK, said: “Arixtra® and Fraxiparine® are established products that have consistently delivered strong revenues. However, our focus is on delivering an unprecedented late-stage pipeline and preparing for the launch of approved medicines. Aspen is a long-term partner of GSK and will be able to dedicate the resources that these products deserve to take them forward. Importantly, we are pleased to be able to preserve the vast majority of jobs through this agreement.”  
GSK already has an 18.6% holding in Aspen, a leading generics manufacturer in the southern hemisphere and Africa’s largest pharmaceutical manufacturer. 
Notes to editors
GlaxoSmithKline - One of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
About Aspen – Aspen, listed on South Africa's JSE Limited, continues to increase the number of lives benefiting from its products, reaching approximately 150 countries across the world. The extensive basket of Aspen products provides treatment for a broad spectrum of acute and chronic conditions experienced throughout all stages of life. Aspen is ranked as Australia’s number one generic pharmaceutical company and has 17 manufacturing facilities at 12 pharmaceutical manufacturing sites on six continents and approximately 7,400 employees.

Amgen Presents New Data From Phase 3 Study Of Talimogene Laherparepvec In Patients With Metastatic Melanoma

Amgen - Investors - RSS Content

"One click, then boom": Spear-phishing could "black out" energy companies, expert warns - We Live Security

"One click, then boom": Spear-phishing could "black out" energy companies, expert warns - We Live Security

China cuts ribbon on free trade zone - Sep. 30, 2013

China cut the ribbon on its new free trade zone in Shanghai on Sunday, with the government promising to deliver a wide range of reforms to develop the economy.


China cuts ribbon on free trade zone - Sep. 30, 2013

Nissan, Mazda recall cars - Sep. 29, 2013

Automakers Nissan and Mazda have announced separate recalls that total nearly 260,000 cars.


Nissan, Mazda recall cars - Sep. 29, 2013

3 Questions for You to Ask Yourself About Employee Health Care

3 Questions for You to Ask Yourself About Employee Health Care

Are You Ready to Unbundle It?

Are You Ready to Unbundle It?

Merck Animal Health Proudly Supports Vaccination Programs Targeted at Reducing Disease in Domestic Pets

Merck Press Release:

Merck Animal Health Proudly Supports Vaccination Programs Targeted at Reducing Disease in Domestic Pets

More Than One Million Doses of Rabies Vaccine Donated
Saturday, September 28, 2013 9:00 am EDT

Public Company Information:

NYSE:
MRK
SUMMIT, N.J.--(BUSINESS WIRE)--In recognition of World Rabies Day, and in an effort to reduce the number of people dying of the disease, Merck Animal Health (known as MSD Animal Health outside the USA and Canada) is proud to support canine rabies vaccination programs in some of the most at-risk regions in the world. To date, more than one million doses of veterinary rabies vaccine have been donated in the effort to eliminate the risk to human health in these regions.
Rabies is a debilitating and deadly problem that affects people and their pets all over the world. According to the World Health Organization, more than 55,000 people die of rabies every year, mostly in Asia and Africa. For this reason, Merck Animal Health has donated up to 300,000 doses of lifesaving veterinary rabies vaccine to those regions this year alone. The program runs in more than 20 developed countries, where participating veterinarians and pet owners who chose Merck Animal Health’s Nobivac® vaccine, have their usage matched by a company donation of rabies vaccine.
“We are extremely proud to have been able to provide more than one million doses of rabies vaccine supporting important programs targeted in the most at-risk regions in the world,“ states David Hallas, Associate Vice President, Merck Animal Health. “These volunteer-based programs work to prevent, control and ultimately eradicate rabies from these regions.”
Afya Serengeti Program in Africa – Means ‘Health in Serengeti’ in Swahili
The Afya Serengeti program, founded as a university-based research project by Professor Sarah Cleaveland in 1997, has prevented thousands of cases of rabies around the Serengeti National Park in Africa. Research has shown that domestic dogs acted as the reservoir of rabies, accounting for 85% of human exposures in the region.
Since the start of the program, deaths attributed to rabies have been reduced by 86% in vaccinated areas and since 2006, no rabies deaths have been reported in any vaccinated African Maasai villages.
‘Mission Rabies’ in India
‘Mission Rabies’ is an initiative of Luke Gamble, organized through his charity, Worldwide Veterinary Service (WVS). The mission has been working toward its goal to vaccinate 50,000 street dogs in 10 rabies hot spots in India throughout September. Of the worldwide deaths attributed to rabies, over a third are reported to occur in India, affecting mostly people of poor or low-income socioeconomic status. Between 30-60% of those deaths being children under 16. It is estimated that 15 million people in India are bitten by animals annually.
Continued Commitment
“We have aspirations to create a world free of rabies, which we believe is achievable through programs like those we support today,” says David Sutton, Technical Director, Merck Animal Health. “Our goal is to not only donate vaccines to help eliminate rabies in the countries with the greatest risk, but to gain additional scientific data that will help us to understand the spread of rabies and how best to control it.”
Merck Animal Health encourages pet owners to help veterinary professionals continue in the fight against rabies and vaccinate their pets today. For more information visitwww.worldrabiesday.orgwww.afya.orgwww.wvs.org.uk and www.nobivac.com.
About Merck Animal Health
Today's Merck is a global healthcare leader working to help the world be well. Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck. Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com.

Saturday, September 28, 2013

Phase 3 Trial Comparing Vectibix® (Panitumumab) to Erbitux® (Cetuximab) Meets Primary Endpoint Of Non-Inferiority Of Overall Survival

Amgen - Investors - RSS Content

Lilly Disappointed in Medicare Decision to Deny Appropriate Patient Access to Beta-Amyloid Imaging Agents, Including Amyvid™ (Florbetapir F 18 Injection), Despite Support From Experts, Patients and the Alzheimer's Disease Community (NYSE:LLY)

Lilly Disappointed in Medicare Decision to Deny Appropriate Patient Access to Beta-Amyloid Imaging Agents, Including Amyvid™ (Florbetapir F 18 Injection), Despite Support From Experts, Patients and the Alzheimer's Disease Community (NYSE:LLY)

A BlackBerry Acquisition, Online Fakes and More

A BlackBerry Acquisition, Online Fakes and More

Online Signup for Small Biz SHOP Exchanges Under Obamacare Delayed A Month

Online Signup for Small Biz SHOP Exchanges Under Obamacare Delayed A Month

ExxonMobil to extend benefits to same-sex couples - Sep. 27, 2013

ExxonMobil to extend benefits to same-sex couples


ExxonMobil to extend benefits to same-sex couples - Sep. 27, 2013

Friday, September 27, 2013

Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analysis of Yervoy® (ipilimumab) Treatment in More Than 1,800 Patients with Metastatic or Locally Advanced or Unresectable Melanoma

Bristol-Myers Squibb Press Release:

Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analysis of Yervoy® (ipilimumab) Treatment in More Than 1,800 Patients with Metastatic or Locally Advanced or Unresectable Melanoma

  • In this pooled analysis of 12 studies, a plateau in the survival curve begins at approximately three years, with some patients followed for up to ten years
  • Three-year estimated survival rate of 22% observed in patients treated with Yervoy
  • Findings based on different doses and regimens and show consistency of long-term survival data for Yervoy in metastatic melanoma
  • Data presented as a late-breaker at the 2013 European Cancer Congress and highlighted at Congress press briefing

Category: 

Friday, September 27, 2013 4:09 pm EDT
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced results from a pooled analysis of survival data for 12 studies (n=1,861) in patients with metastatic or locally advanced or unresectable melanoma who were treated with Yervoy® (ipilimumab) at different doses and regimens. A plateau in the survival curve begins at approximately three years, with follow-up of up to ten years in some patients. Approximately 22% of patients were alive at three years. The data will be presented at the 2013 European Cancer Congress on September 28 at 1:00 p.m. CEST and were highlighted at a Congress press briefing (Abstract # 24LBA, “Pooled analysis of long-term survival data from Phase 2 and Phase 3 trials of ipilimumab in metastatic or locally advanced, unresectable melanoma”).
Safety data were not included in this analysis. However, safety data from these individual studies have been reported. Overall, the types of adverse events (AEs) attributed to Yervoy are generally mechanism (immune)-based. Yervoy can result in severe and fatal immune-related adverse reactions due to T-cell activation and proliferation. In these clinical trials, adverse events associated with Yervoy were managed with protocol-specific guidelines, including the administration of systemic corticosteroids, dose interruption/discontinuation and/or other immunosuppressants.
“This pooled analysis reinforces the long-term survival data seen in the individual studies and provides additional insight into the overall survival of metastatic melanoma patients treated with Yervoy,” said Brian Daniels, senior vice president, Global Development and Medical Affairs. “The durability and consistency of long-term survival observed in this analysis is encouraging as we continue to advance the research and development of our immuno-oncology portfolio.”
“In this analysis, approximately 26% of treatment-naïve and 20% of previously-treated patients were alive at three years after being treated with an ipilimumab regimen,” said F. Stephen Hodi, M.D., Department of Medicine, Harvard Medical School, Dana-Farber Cancer Institute. “This pooled analysis is encouraging, particularly when considering that metastatic melanoma is one of the most aggressive forms of cancer and historically, average survival was just six to nine months.”
About The Analysis
This pooled analysis was conducted to provide a more precise estimate of the long-term survival effect of Yervoy in patients with metastatic melanoma. It is comprised of patient-level data from 12 prospective and retrospective studies, including two Phase 3 trials (n=790), eight Phase 2 trials (n=821), and two retrospective, observational studies (n=250), which have been or will be reported on as individual studies. Three studies included overall survival follow-up in some patients for up to ten years.
The analysis included both previously-treated (n=1,257) and previously untreated patients (n=604) who received Yervoy at different doses and regimens. The majority of patients received Yervoy 3 mg/kg (n=965) or 10 mg/kg (n=706). Yervoy was given every 3 weeks for 4 doses, and most studies included the option to receive either Yervoy retreatment or Yervoy maintenance therapy for eligible patients.
About Yervoy
Yervoy, which is a recombinant, human monoclonal antibody, blocks the cytotoxic T- lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of Yervoy’s effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumor immune responses. On March 25, 2011, the FDA approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 40 countries.
YERVOY® (ipilimumab) INDICATION & IMPORTANT SAFETY INFORMATION
YERVOY (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma.
Important Safety Information
WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. 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) 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.
Recommended Dose Modifications
Withhold dose for any moderate immune-mediated adverse reactions or for symptomatic endocrinopathy until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5 mg prednisone or equivalent per day.
Permanently discontinue YERVOY for any of the following:
  • Persistent moderate adverse reactions or inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day
  • Failure to complete full treatment course within 16 weeks from administration of first dose
  • Severe or life-threatening adverse reactions, including any of the following:
    • Colitis with abdominal pain, fever, ileus, or peritoneal signs; increase in stool frequency (≥7 over baseline), stool incontinence, need for intravenous hydration for >24 hours, gastrointestinal hemorrhage, and gastrointestinal perforation
    • AST or ALT >5 × the upper limit of normal (ULN) or total bilirubin >3 × the ULN
    • Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full-thickness dermal ulceration or necrotic, bullous, or hemorrhagic manifestations
    • Severe motor or sensory neuropathy, Guillain-Barré syndrome, or myasthenia gravis
    • Severe immune-mediated reactions involving any organ system
    • Immune-mediated ocular disease which is unresponsive to topical immunosuppressive therapy
Immune-mediated Enterocolitis:
  • In the pivotal Phase 3 study in YERVOY (ipilimumab)-treated patients, 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%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 (5%) patients
  • Across all YERVOY-treated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis
  • Infliximab was administered to 5 of 62 (8%) patients with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids
  • Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms
  • Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients
  • Withhold YERVOY (ipilimumab) for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent)
Immune-mediated Hepatitis:
  • In the pivotal Phase 3 study in YERVOY-treated patients, 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%
  • 13 (2.5%) additional YERVOY-treated patients experienced moderate hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations >2.5x but ≤5x the ULN or total bilirubin elevation >1.5x but ≤3x the ULN; Grade 2)
  • Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution
  • Permanently discontinue YERVOY in patients with Grade 3-5 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids
  • Withhold YERVOY in patients with Grade 2 hepatotoxicity
Immune-mediated Dermatitis:
  • In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening, or fatal immune-mediated dermatitis (e.g., 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
  • There were 63 (12%) YERVOY-treated patients with moderate (Grade 2) dermatitis
  • Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated
  • Permanently discontinue YERVOY (ipilimumab) in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. Withhold YERVOY in patients with moderate to severe signs and symptoms
  • Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically. Administer topical or systemic corticosteroids if there is no improvement within 1 week
Immune-mediated Neuropathies:
  • In the pivotal Phase 3 study in YERVOY-treated patients, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported
  • Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-Barré syndrome have been reported
  • Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities) such as Guillain-Barré–like syndromes
  • Institute medical intervention as appropriate for management of severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities)
Immune-mediated Endocrinopathies:
  • In the pivotal Phase 3 study in YERVOY- treated patients, 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
  • Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 (2.3%) YERVOY (ipilimumab)-treated patients and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing’s syndrome
  • Median time to onset of moderate to severe immune-mediated endocrinopathy was 11 weeks and ranged up to 19.3 weeks after the initiation of YERVOY
  • Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism
    • Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms should be considered immune-mediated
    • Monitor thyroid function tests and clinical chemistries at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland
  • Withhold YERVOY in symptomatic patients. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. Long-term hormone replacement therapy may be necessary
Other Immune-mediated Adverse Reactions, Including Ocular Manifestations:
  • In the pivotal Phase 3 study in YERVOY-treated patients, clinically significant immune-mediated adverse reactions seen in <1% were: nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, and hemolytic anemia
  • Across the clinical development program for YERVOY, likely immune-mediated adverse reactions also reported with <1% incidence were: myocarditis, angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, pancreatitis, arthritis, autoimmune thyroiditis, sarcoidosis, neurosensory hypoacusis, autoimmune central neuropathy (encephalitis), myositis, polymyositis, and ocular myositis
  • Permanently discontinue YERVOY (ipilimumab) for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions
  • Administer corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy
Pregnancy & Nursing:
  • YERVOY is classified as pregnancy category C. There are no adequate and well-controlled studies of YERVOY in pregnant women. Use YERVOY during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • Human IgG1 is known to cross the placental barrier and YERVOY is an IgG1; therefore, YERVOY has the potential to be transmitted from the mother to the developing fetus
  • It is not known whether YERVOY is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants from YERVOY, a decision should be made whether to discontinue nursing or to discontinue YERVOY
Common Adverse Reactions:
  • 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%)
Please see Full Prescribing Information, including Boxed WARNING regarding immune-mediated adverse reactions available at www.bms.com.
YERVOY is a registered trademark of Bristol-Myers Squibb Company.
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, visitwww.bms.com, or follow us on Twitter at http://twitter.com/bmsnews.