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Friday, October 31, 2014

FedEx Express Seeks National Mediation Board Assistance to Expedite Progress of Pilot Negotiations

From FedEx:


FedEx Express Seeks National Mediation Board Assistance to Expedite Progress of Pilot Negotiations

FedEx Express, a subsidiary of FedEx Corp. (NYSE:FDX), has formally requested assistance from the National Mediation Board (NMB) to expedite its ongoing pilot negotiations. The NMB is the U.S. governmental agency that oversees labor agreements for entities covered by the Railway Labor Act (RLA), such as airlines, railroads and express companies.
The company and its pilots, who are represented by the Air Line Pilots Association (ALPA), have been engaged in contract talks for more than a year. The current contract became amendable on February 25, 2013 and the two sides reached a tentative agreement on 20 of the 31 contract sections in September, 2014.
Under the RLA, the terms and conditions of the existing contract between the company and ALPA do not expire until the full multi-step RLA process is exhausted.  In the meantime, the progression of negotiations into the mediation stage has no impact on company operations or its ability to provide highly reliable service to customers. 
“FedEx Express is simply interested in expediting the negotiation process leading to a contract that is fair and reasonable for all parties,” said James R. Parker, executive vice president, air operations, FedEx Express.  “The majority of airline contracts require NMB mediation to reach a final agreement, and we believe the time has come for our negotiations to move to that phase.”
For more details on the NMB request, click here.

F-16

From Raytheon:




It's F-16 Friday! Free wallpaper downloads are here:http://rtn.co/1E8ssCN #avgeek

Bristol-Myers Squibb’s ZymoGenetics R&D Facility Earns LEED Silver Certification from U.S. Green Building Council

From Bristol-Myers Squibb:


Bristol-Myers Squibb’s ZymoGenetics R&D Facility Earns LEED Silver Certification from U.S. Green Building Council

Seattle site is one of only three laboratories worldwide to achieve LEED Silver designation
Friday, October 31, 2014 9:23 am EDT
"Buildings are a prime example of how human systems integrate with natural systems"
Since its founding 100 years ago, the historic Lake Union Steam Plant, now home to Bristol-Myers Squibb’s ZymoGenetics R&D subsidiary, has been a symbol of economic and civic importance to the Eastlake community. 
A century later, it also is a symbol of environmental sustainability. Today, ZymoGenetics is among an elite group of laboratories around the world that have earned the U.S. Green Building Council’s LEED® (Leadership in Energy and Environmental Design) Silver certification for Existing Buildings: Operations and Maintenance.
LEED certification is recognized worldwide as the premier mark of achievement in green building and is awarded at one of four levels – certified, silver, gold and platinum – based on points earned on a LEED scorecard. ZymoGenetics’ Silver certification is a formal acknowledgement of the numerous internal and external environmental considerations that were implemented to make the site a clean, energy-efficient laboratory complex.
“The LEED Silver certification awarded to Bristol-Myers Squibb’s ZymoGenetics R&D subsidiary is a demonstration of our commitment to economic, social and environmental sustainability,” says Susan Voigt, vice president, Environment, Health, Safety & Sustainability, Bristol-Myers Squibb. “We are proud of the improvements that have been implemented at the facility, which is at the forefront of the research, development and manufacturing of biologic medicines that help patients prevail over serious diseases.”
ZymoGenetics’ two-year LEED certification project began in July 2012. Since then, the site has met or surpassed LEED standards for air quality and temperature, indoor plumbing and fixture efficiency, energy efficiency, and acoustics. The site has a superior energy performance rating compared to laboratories of similar type and function using the Labs21 Environmental Performance Criteria. LED fixtures and occupancy sensors were installed as part of a lighting upgrade project, and the site has reduced water use by 42% since installing new plumbing fixtures.
“Beyond recognition as a green building, the certification also has pragmatic benefits,” says Mike Fitzpatrick, director, Site & Business Operations, ZymoGenetics. “We increased operational efficiency and reduced our year-over-year usage of electricity by 17%, natural gas by 38% and water by 17%, in addition to reducing our maintenance costs and improving the well-being of our employees, all while reducing our carbon footprint and impact on the environment.”
The site also has policies governing sustainable purchasing, solid waste management and green cleaning, and works with key vendors to ensure their processes, equipment and supplies meet rigorous standards.
Worldwide, only seven laboratories have earned LEED certification for existing building operations and maintenance, and ZymoGenetics is one of only three laboratories that are LEED Silver certified. Six of the LEED certified laboratory existing building operations and maintenance projects are in the U.S., and two of them are in the State of Washington.
ZymoGenetics focuses on the discovery and early manufacture of therapeutic proteins, or biologics, specifically those with potential applications in Immuno-Oncology (I-O). Bristol-Myers Squibb is at the forefront of this science,which represents a potentially transformational approach to fighting cancer. ZymoGenetics also has core expertise and process development capabilities in the early manufacturing of microbial- and mammalian-based proteins to support toxicology studies and early-stage clinical trials.
Over 50,000 projects are currently participating in the commercial and institutional LEED rating systems, comprising over 9.3 billion square feet or construction space in all 50 states and 135 countries.
“Buildings are a prime example of how human systems integrate with natural systems,” said Rick Fedrizzi, President, CEO & Founding Chair, U.S. Green Building Council. “The ZymoGenetics project efficiently uses our natural resources and makes an immediate, positive impact on our planet, which will tremendously benefit future generations to come.”
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, please visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

Can anything save Sony? - Oct. 30, 2014

Sony is in dire straits.

Major rating agencies Fitch and Moody's have downgraded the company to "junk" status. Standard & Poor's has warned it could soon do the same. The company has announced plans to scale back its smartphone business.


Can anything save Sony? - Oct. 30, 2014

Thursday, October 30, 2014

FedEx Freight Reports Teamsters Withdraw Petition at North Harrisburg Facility

From FedEx:


FedEx Freight Reports Teamsters Withdraw Petition at North Harrisburg Facility

After months of trying to convince FedEx Freight drivers in Middletown, PA (the North Harrisburg facility) to join the Teamsters, the union has withdrawn its election petition on the eve of the vote.  FedEx Freight has been notified by the National Labor Relations Board that the election at North Harrisburg - previously scheduled for tomorrow - has been officially cancelled.  The union would only take this action if it recognized that it would not win the election.
“We are extremely grateful to our team members at North Harrisburg for their support of the company.  We continue to believe that the attempted Teamster interference in our working relationship is unnecessary and unwelcome,” said William J. Logue, President and CEO of FedEx Freight.   “We look forward to building on our direct relationships and further enhancing our employee and customer experiences.”

MedStar Health Signs Expanded Agreement with Cerner

From Cerner:


MedStar Health Signs Expanded Agreement with Cerner

October 30, 2014
New Strategic Alliance Designed to Advance Quality, Efficiency of Care through Health Information Technology
KANSAS CITY, Mo. — Oct. 30, 2014 — MedStar Health, the largest healthcare provider in Maryland and the Washington, D.C. region, and Cerner (Nasdaq: CERN) today announced an expanded partnership with a seven-year agreement that will streamline operations, help improve the quality of patient care and develop technologies that align with MedStar’s vision to be the trusted leader in caring for people and advancing health.

The new alignment will allow access to all Cerner solutions and services throughout MedStar’s 10 hospitals and 3,000 plus beds, as well as the ambulatory and post-acute network. Cerner will provide MedStar an expanded enterprise Electronic Health Record (EHR) that will provide clinicians seamless access to patient information across the continuum of care.

“Our new partnership represents an opportunity to change the future of care delivery,” said Kenneth A. Samet, FACHE, President and CEO of MedStar. “With our mix of clinical and IT expertise, we can proactively develop innovative solutions that adapt to the ever changing healthcare landscape while meeting the needs of our patients and their families.”

In addition, Cerner will provide an onsite, Maryland-based team to collaborate on the execution of MedStar’s IT goals.

MedStar and Cerner have been partners since 1999. As part of the new long-term strategic agreement, Cerner and MedStar will focus on optimizing, extending and leveraging MedStar’s IT footprint, working collaboratively to integrate data and process in order to deliver the highest quality and most cost-effective health care possible. Further, Cerner and MedStar together will work on joint innovation and performance improvement initiatives.

“Our enhanced agreement will reinforce MedStar’s position as one of the nation’s top health systems,” said Neal Patterson, Chairman and Chief Executive Officer of Cerner Corporation. “We’re proud to continue our relationship with MedStar and look forward to shared work that delivers an even higher standard of care for the communities that MedStar serves.”
Through the new alliance with Cerner, MedStar plans to further the work of the MedStar Institute for Innovation by aligning more closely around technology innovation.
MedStar cares for more than a half million patients each year across Maryland and the Washington, D.C., region in its hospitals, urgent care and ambulatory care facilities, and physician offices. As the largest healthcare provider in Maryland and the Washington, D.C., region, MedStar’s 10 hospitals, the MedStar Institute for Innovation, MedStar Physician Partners, and our other programs and services are recognized regionally and nationally for excellence in medical care. Many of MedStar’s hospitals are continuously recognized as Best Hospitals by U.S.News and World Report. Recently, the health system also was named one of the nation’s Most Wired by Hospital and Health Networks Magazine.
About Cerner
Cerner’s health information technologies connect people, information and systems at more than 14,000 facilities worldwide. Recognized for innovation, Cerner solutions assist clinicians in making care decisions and enable organizations to manage the health of populations. The company also offers an integrated clinical and financial system to help health care organizations manage revenue, as well as a wide range of services to support clients’ clinical, financial and operational needs. Cerner’s mission is to contribute to the improvement of health care delivery and the health of communities. Nasdaq: CERN. For more information about Cerner, visit cerner.com, read our blog at cerner.com/blog, connect with us on Twitter at twitter.com/cerner and on Facebook at facebook.com/cerner. Certain trademarks, service marks and logos set forth herein are property of Cerner Corporation and/or its subsidiaries. All other non-Cerner marks are the property of their respective owners.

About MedStar Health
MedStar Health is a not-for-profit health system dedicated to caring for people in Maryland and the Washington, D.C., region, while advancing the practice of medicine through education, innovation and research. MedStar’s 30,000 associates, 6,000 affiliated physicians, 10 hospitals, ambulatory care and urgent care centers, and the MedStar Health Research Institute are recognized regionally and nationally for excellence in medical care. As the medical education and clinical partner of Georgetown University, MedStar trains more than 1,100 medical residents annually. MedStar Health’s patient-first philosophy combines care, compassion and clinical excellence with an emphasis on customer service. For more information, visit MedStarHealth.org.

Bristol-Myers Squibb and Lonza Expand Manufacturing Agreement

Bristol-Myers Squibb News Release:


Bristol-Myers Squibb and Lonza Expand Manufacturing Agreement

Category: 

Thursday, October 30, 2014 1:00 pm EDT
"We are pleased to extend our relationship with Bristol-Myers Squibb for the commercial production of their innovative drug substance, said Marc Funk, COO of Lonza’s Pharma & Biotech Segment."
NEW YORK & BASEL, Switzerland--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Lonza today announced a multi-year expansion of their existing biologics manufacturing agreement. The contract expansion will include the production of commercial quantities of a second Bristol-Myers Squibb biologic medicine at Lonza’s mammalian manufacturing facility in Portsmouth, New Hampshire. Financial terms were not disclosed.
Biologic medicines that treat serious diseases are an integral part of Bristol-Myers Squibb’s specialty care portfolio and R&D pipeline. Bristol-Myers Squibb and Lonza have been collaborating since 2003 to produce commercial supplies of a biologics medicine marketed by Bristol-Myers Squibb worldwide. Currently, Lonza also produces clinical supplies of an investigational biologics medicine for Bristol-Myers Squibb.
“Our expanded relationship with Lonza is an important example of our global manufacturing strategy to meet anticipated demand for our commercial biologics portfolio and prepare to bring our late-stage clinical assets to patients by supplementing our in-house manufacturing capabilities,” said Lou Schmukler, president, Global Manufacturing & Supply, Bristol-Myers Squibb.
Lonza’s development and manufacturing facilities offer proven expression systems and established platform processes for streamlined scale-up throughout the clinical pipeline. In addition to its state-of-the-art Portsmouth facility, Lonza offers three additional clinical-to-commercial mammalian production facilities in Tuas, Singapore; Porrino, Spain; and Slough, United Kingdom.
"We are pleased to extend our relationship with Bristol-Myers Squibb for the commercial production of their innovative drug substance, said Marc Funk, COO of Lonza’s Pharma & Biotech Segment. “This reinforces Lonza’s mission to support life-saving medicines by being a reliable supplier of drug substance for our customers with high-quality commercial GMP manufacturing services delivered to the market.”
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, please visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
About Lonza
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life.
Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 10,000 employees worldwide. The company generated sales of about CHF 3.6 billion in 2013 and is organized into two market-focused segments: Pharma & Biotech and Specialty Ingredients. Further information can be found atwww.lonza.com.

Duke Energy Florida warns Tampa Bay area restaurants and small businesses to beware of utility payment scams - Duke Energy

ST. PETERSBURG, FLA. -
Duke Energy Florida has seen an increase in utility payment scams in the area. The latest targets appear to be local restaurants and other small businesses.
Several business owners have reported receiving unsolicited calls from someone who falsely claims to be a Duke Energy representative. The thief tells the customer his or her last electric payment wasn’t paid in full and service will be disconnected if a large payment isn’t made – usually within less than an hour.


Duke Energy Florida warns Tampa Bay area restaurants and small businesses to beware of utility payment scams - Duke Energy

Phase 2 Objective Response Rate and Survival Data for Opdivo (nivolumab) in Heavily Pre-treated Advanced Squamous Cell Non-Small Cell Lung Cancer to be Presented at the 2014 Chicago Multidisciplinary Symposium on Thoracic Oncology

Bristol-Myers Squibb News Release:


Phase 2 Objective Response Rate and Survival Data for Opdivo (nivolumab) in Heavily Pre-treated Advanced Squamous Cell Non-Small Cell Lung Cancer to be Presented at the 2014 Chicago Multidisciplinary Symposium on Thoracic Oncology

  • In CheckMate -063, the objective response rate was 15% in patients treated with single agent Opdivo and median duration of response was not reached
  • 41% of Opdivo-treated patients were alive at one year
  • Types and frequency of treatment-related adverse events were consistent with early clinical experience and managed using recommended treatment algorithms
  • Rolling submission initiated with FDA in April based on CheckMate 063; company expects to complete submission by year end

Category: 

Thursday, October 30, 2014 9:00 am EDT
"The Phase 2 findings from CheckMate -063 are encouraging as there are no effective treatment options for patients with refractory squamous cell lung cancer after their disease has progressed through two prior therapies"
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced results from CheckMate -063, a Phase 2 single-arm, open-label study ofOpdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, administered as a single agent in patients with advanced squamous cell non-small cell lung cancer (NSCLC) who have progressed after at least two prior systemic treatments with 65% receiving three or more prior therapies (n=117). With approximately 11 months of minimum follow up, the objective response rate (ORR, the study’s primary endpoint) was 15% (95% CI = 8.7, 22.2) as assessed by an independent review committee (IRC) using RECIST 1.1 criteria and the median duration of response was not reached. The estimated one-year survival rate was 41% (95% CI = 31.6, 49.7) and median overall survival (mOS) was 8.2 months (95% CI = 6.05, 10.91). These data will be presented during the Plenary Session at the 2014 Chicago Multidisciplinary Symposium on Thoracic Oncology on October 31 (Abstract #3462).
“The Phase 2 findings from CheckMate -063 are encouraging as there are no effective treatment options for patients with refractory squamous cell lung cancer after their disease has progressed through two prior therapies,” said Suresh S. Ramalingam, MD, Professor and Director of Medical Oncology, Winship Cancer Institute of Emory University. “The results are also consistent with Phase 1 data previously reported from Study -003.” Historically, the expected one-year survival rate for third-line squamous cell NSCLC patients is approximately 5.5% - 18%.1,2
Grade 3-4 drug-related adverse events (AEs) were reported in 17.1% of patients. The most common Grade 3-4 AEs (greater than or equal to 2%) were fatigue (4.3%), pneumonitis (3.4%), and diarrhea (2.6%). Discontinuations due to drug-related AEs of any grade occurred in 12% of patients and there were two drug-related deaths in patients with multiple comorbidities and in the setting of progressive disease.
“Results from CheckMate -063 offer further clinical evidence of the potential of immuno-oncology as an innovative approach to treating this disease,” said Michael Giordano, senior vice president, Head of Development, Oncology. “We are committed to addressing the significant unmet medical needs of patients with lung cancer and have the broadest development program evaluating our approved and investigational immuno-oncology agents across multiple lines of therapy and histology.”
Bristol-Myers Squibb’s lung cancer research and development program is evaluating its approved and investigational immunotherapies – either as single agents or as part of combination regimens – across lines of therapy, histologies and biomarker expression. Among these are six ongoing Phase 3 trials. Four Phase 3 trials are evaluating Opdivo (nivolumab) as a single agent – three in previously treated patients (CheckMate -017, CheckMate -057 and CheckMate -153 ) and one in chemotherapy-naïve patients (CheckMate -026). Two Phase 3 trials evaluating Yervoy in combination with chemotherapy in newly diagnosed small cell lung cancer (Study -156) and squamous cell NSCLC (Study -104) are ongoing.
Bristol-Myers Squibb has proposed the name Opdivo (pronounced op-dee-voh),which, if approved by health authorities, will serve as the trademark for nivolumab.
About the Checkmate -063 Trial Design & Detailed Results
Checkmate -063 is a Phase 2 single arm, open-label study designed to assess advanced squamous cell NSCLC patients who progressed after both platinum-based therapy and at least one additional systemic therapy with an ECOG Performance Status of 0 or 1 who were treated with Opdivo as a single agent 3mg/kg by intravenous infusion every two weeks until disease progression or treatment discontinuation (n=117). The primary endpoint was ORR as assessed by an IRC using RECIST 1.1 criteria. Responders were further characterized by duration of response. Secondary endpoints included investigator-assessed ORR. Overall survival, PFS and efficacy by PD-L1 expression status were exploratory endpoints. All treated patients had received at least two prior systemic regimens with 65% receiving greater than or equal to three prior therapies. Seventy-six percent of patients were within three months of completion of their most recent therapy. The best response to the most recent prior systemic therapy was progressive disease in 61% of patients.
With approximately 11 months of minimum follow up, the ORR was 15% (95% CI = 8.7, 22.2) as assessed by an IRC using RECIST 1.1 criteria and the median duration of response was not reached. The estimated one-year survival rate was 41% (95% CI = 31.6, 49.7) and mOS was 8.2 months (95% CI = 6.05, 10.91). An additional 26% of patients had stable disease with a median duration of six months (95% CI, 4.73, 10.91) giving a disease control rate (defined as partial response + stable disease) of 41%. For patients with quantifiable PD-L1 expression, responses were observed independent of PD-L1 status.
Grade 3-4 drug-related AEs were reported in 17.1% of patients. The most common (greater than or equal to 2%) Grade 3-4 AEs were fatigue (4.3%), pneumonitis (3.4%), and diarrhea (2.6%). Drug-related AEs generally were manageable with corticosteroids and/or supportive care as per established safety algorithms. Discontinuations due to drug-related AEs of any grade occurred in 12% of patients and there were two drug-related deaths in patients with muliple comorbidities and in the setting of progressive disease.
About Opdivo (nivolumab)
Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is an investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells.
Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 35 trials – as monotherapy or in combination with other therapies – in which more than 7,000 patients have been enrolled worldwide. Among these are several potentially registrational trials in NSCLC, melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma and non-Hodgkin lymphoma.
In 2013, the FDA granted Fast Track designation for Opdivo in NSCLC, melanoma and RCC. In April 2014, the company initiated a rolling submission with the FDA forOpdivo in third-line pre-treated squamous cell NSCLC based on CheckMate -063 and expects to complete the submission by year-end. The FDA granted OpdivoBreakthrough Therapy Designation in May 2014 for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab. On July 4, Ono Pharmaceutical Co. announced that Opdivo received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma, making Opdivo the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. On September 26, Bristol-Myers Squibb announced that the FDA accepted for priority review the Biologics License Application for previously treated advanced melanoma, and the Prescription Drug User Fee Act (PDUFA) goal date for a decision is March 30, 2015. The FDA also granted Opdivo Breakthrough Therapy status for this indication. In the European Union, the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for Opdivo in advanced melanoma and lung cancer. The advanced melanoma application has also been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally, resulting in more than 1.5 million deaths each year according the World Health Organization. NSCLC is one of the most common types of the disease and accounts for approximately 85 percent of cases. Survival rates vary depending on the stage and type of the cancer when it is diagnosed. Globally, the five-year survival rate for Stage I NSCLC is between 47 and 50 percent; for Stage IV NSCLC, the five-year survival rate drops to two percent. Historically, the expected one-year survival rate for third-line squamous cell NSCLC patients is approximately 5.5% - 18%.i, ii
Immuno-Oncology at Bristol-Myers Squibb
Surgery, radiation, cytotoxic or targeted therapies have represented the mainstay of cancer treatment over the last several decades, but long-term survival and a positive quality of life have remained elusive for many patients with advanced disease.
To address this unmet medical need, Bristol-Myers Squibb is leading advances in the innovative field of immuno-oncology, which involves agents whose primary mechanism is to work directly with the body’s immune system to fight cancer. The company is exploring a variety of compounds and immunotherapeutic approaches for patients with different types of cancer, including researching the potential of combining immuno-oncology agents that target different and complementary pathways in the treatment of cancer.
Bristol-Myers Squibb is committed to advancing the science of immuno-oncology, with the goal of changing survival expectations and the way patients live with cancer.
About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivoglobally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono Pharmaceutical further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical 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.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that Opdivo will receive regulatory approval in the U.S. or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
1 Massarelli E, et al. Lung Cancer 2003;39: 55-61
2 Penrod JR, et al. Poster presentation at ASCO 2014. Poster 45

ATK Reports FY15 Second Quarter Operating Results - Oct 30, 2014

ATK Reports FY15 Second Quarter Operating Results - Oct 30, 2014

AmerisourceBergen Reports Fourth Quarter and Fiscal Year 2014 Results

RSS Feeds - AmerisourceBergen

Johnson Controls reports strong 2014 fourth quarter earnings; higher revenues in all primary businesses

News & Press

Lilly Shares Insights from Decade-Long Technology Transfer Experience (NYSE:LLY)

INDIANAPOLISOct. 30, 2014 /PRNewswire/ -- Today Eli Lilly and Company (NYSE: LLY) published details of its long-standing technology transfer program to increase the global supply of medicines for multidrug-resistant tuberculosis (MDR-TB). Begun in 2003, the effort included Lilly donating manufacturing technology and know-how for two antibiotics to pharmaceutical manufacturers in ChinaIndiaRussia and South Africa - all MDR-TB 'hot spots.' It also served as the foundation for the Lilly MDR-TB Partnership, the company's largest-ever philanthropic effort.



Lilly Shares Insights from Decade-Long Technology Transfer Experience (NYSE:LLY)

Samsung profit plunges 60% amid smartphone troubles - Oct. 29, 2014

Samsung earnings plunged in the third quarter as the company's smartphone business was squeezed by competitors at both ends of the cost spectrum.

The South Korea-based firm posted operating profit of 4.1 trillion won ($3.9 billion) for the third quarter -- a 60% decline from the previous year.


Samsung profit plunges 60% amid smartphone troubles - Oct. 29, 2014

Wednesday, October 29, 2014

ATK Supports ULA Atlas V Rocket Launch of U.S. Air Force GPS Satellite

From ATK:


ATK Supports ULA Atlas V Rocket Launch of U.S. Air Force GPS Satellite

Highly-Engineered ATK Products Enable Improved Global Positioning On Earth

Oct 29, 2014
Integrated ATK (NYSE: ATK) products enabled the successful launch of both the United Launch Alliance (ULA) Atlas V vehicle and the GPS satellite launched today from Cape Canaveral Air Force Station, Florida.
Now in Medium Earth Orbit (MEO), approximately 11,000 miles above the Earth, the eighth GPS IIF satellite in the constellation will replace older, first-generation GPS satellites and provide improved accuracy, signal strength and quality to America’s warfighters, allies and civilian users worldwide. Boeing (NYSE: BA) designed and built the GPS IIF satellite for the U.S. Air Force.
“The Atlas V and GPS programs encompass the scope and scale of ATK’s highly engineered products and affordable innovation,” said Blake Larson, President of ATK’s Aerospace Group. “Both military and civilian GPS users around the world will benefit from increased capability as a result of our team’s collective dedication and execution excellence.”
The ATK components, in both the Atlas V launch vehicle and satellite, utilize the latest, cutting-edge technology across multiple ATK facilities. These include large composite structures, retro motors, state-of-the art solar arrays and other critical components on the GPS IIF satellite.
For the ULA Atlas V rocket, ATK produced the 10-foot diameter composite heat shield, which provides higher performance with lower weight, and essential protection for the first stage of the launch vehicle from engine exhaust temperatures in excess of 4,000 degrees Fahrenheit. The assembly was fabricated using advanced fiber placement manufacturing techniques at ATK's Iuka, Mississippi facility. This is the 50th Atlas V launch using ATK-built composite structures.
This launch also marked the 16th successful flight of ATK-produced retro motors. Eight of these solid motors supported separation of the spent first stage. The Atlas retrorocket is built at ATK’s Missile Defense and Controls facility in Elkton, Maryland.
The Block IIF series will replace the GPS Block IIA satellites that were launched between 1990 and 1997. The IIF space vehicles provide improved accuracy, enhanced internal atomic clocks, better anti-jam resistance, a civil signal for commercial aviation and a longer design life. The GPS IIF-8 satellite provides space-based system global location and time information in all weather conditions.
For the GPS IIF-8 satellite, ATK provided a host of products and services. ATK’s Goleta, California facility designed and manufactured the satellite solar arrays and a deployment boom. ATK has achieved 100 percent on-orbit success on all solar arrays and deployable systems delivered and launched to date. ATK’s San Diego, California facility manufactured the composite solar array substrates. ATK’s Commerce, California facility had responsibility for the ullage tank assembly, including the blankets, heaters, thermistors and pressurant lines. This tank is a spherical vessel constructed of titanium.
As a leader in space thermal control technology, ATK’s Beltsville, Maryland facility provided heat pipes for the GPS IIF equipment and radiator panels. The company has delivered more than 50,000 heat pipes to the space industry with perfect on-orbit mission success record. ATK’s Rancho Bernardo, California facility performed final assembly and RF (Radio Frequency) testing of the antenna suite for GPS IIF between 2003 and 2010.
ATK is an aerospace, defense, and outdoor sports and recreation company with operations in 21 states, Puerto Rico, and internationally. News and information can be found on the Internet at www.atk.com, on Facebook at www.facebook.com/atk, or on Twitter @ATK.

Rents are soaring -- and so are evictions - Oct. 29, 2014

In cities across the United States, millions of people will be kicked out of their homes this year.

Some can't afford their soaring rent, others are getting evicted over minor violations by landlords eager to get higher paying tenants in place.


Rents are soaring -- and so are evictions - Oct. 29, 2014

Stuck in cycle of debt, domestic violence victims battle banks - Oct. 29, 2014

Amy Kukec thought leaving her abusive husband would be the beginning of a new life, but so far she's hit one debilitating financial roadblock after another.

Weeks before the couple separated in January, Kukec says her husband overdrew her Chase bank account by several hundred dollars.


Stuck in cycle of debt, domestic violence victims battle banks - Oct. 29, 2014

Costco isn't the only store closed on Thanksgiving day - Oct. 29, 2014

Once upon a time, you could eat Thanksgiving dinner without worrying whether you might miss a doorbuster deal.

But in the last couple of years, stores have been falling over each other to offer Black Friday sales on Thursday itself, opening their doors before many people are even done with their turkey.


Costco isn't the only store closed on Thanksgiving day - Oct. 29, 2014

Pfizer Receives FDA Accelerated Approval for TRUMENBA® (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Adolescents and Young Adults

From Pfizer:


Pfizer Receives FDA Accelerated Approval for TRUMENBA® (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Adolescents and Young Adults

TRUMENBA is the First and Only Approved Vaccine in the U.S. for the Prevention of Meningococcal Meningitis B
Wednesday, October 29, 2014 2:44 pm EDT

Dateline:

NEW YORK

Public Company Information:

NYSE:
PFE
US7170811035
"The approval of TRUMENBA is an important public health advance in helping to protect adolescents and young adults from invasive meningococcal serogroup B disease, also known as meningitis B"
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TRUMENBA® (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidisserogroup B in individuals 10 through 25 years of age. Approval of TRUMENBA is based on demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed. As part of the accelerated approval process, Pfizer will complete its ongoing studies to confirm the effectiveness of TRUMENBA against diverse serogroup B strains.
TRUMENBA was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs.
“The approval of TRUMENBA is an important public health advance in helping to protect adolescents and young adults from invasive meningococcal serogroup B disease, also known as meningitis B,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer Inc. “Pfizer is proud to have developed the first and only FDA-approved vaccine that addresses an existing and urgent need in the efforts to help prevent this uncommon but life-threatening and devastating disease in the U.S. As a next step, we look forward to participating in discussions with the CDC regarding potential meningococcal group B vaccination recommendations.”
Meningococcal disease can be unpredictable and occur quickly and without warning in otherwise healthy individuals.1,2 Outbreaks and cases of meningococcal group B disease occurred in the U.S. in 2013 and 2014.3,4,5,6
“Meningococcal meningitis B is a devastating disease, which though rare, significantly impacts affected individuals and families,” said Frankie Milley, Meningitis Angels, Founder/National Executive Director and mother to an only child who died from meningitis. “Vaccines have been available and recommended since 2005 to help protect against four other serogroups of meningococcal disease, and we hope that TRUMENBA will become a recommended vaccine in routine adolescent immunization programs to help prevent meningococcal B disease.”
“Meningococcal disease can progress from initial symptoms to death within 24 hours, and is often challenging to diagnose and distinguish from diseases that are more common and less serious, making preventative vaccination critically important,” said study investigator Stanley L. Block, MD, pediatrician at Kentucky Pediatric/Adult Research. “In clinical trials, TRUMENBA demonstrated the ability to induce functional immune responses to four serogroup B strains representative of prevalent strains in the United States. As a physician, I am pleased that a meningococcal meningitis B vaccine is now available to help protect adolescents and young adults.”
TRUMENBA is to be administered as a 3-dose series at months 0, 2 and 6 in the 10 through 25 year old age group.7
For the full prescribing information for TRUMENBA, please visit www.pfizer.com.
About TRUMENBA® (meningococcal group B vaccine)
TRUMENBA is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidisserogroup B, one from fHBP subfamily A and one from subfamily B (A05 and B01, respectively). fHBP is one of many proteins found on the surface of meningococci and contributes to the ability of the bacterium to avoid host defenses. fHBPs can be categorized into two immunologically distinct subfamilies, A and B. The susceptibility of serogroup B meningococci to complement-mediated, antibody-dependent killing following vaccination with TRUMENBA is dependent on both the antigenic similarity of the bacterial and vaccine fHBPs, as well as the amount of fHBP expressed on the surface of the invading meningococci.7
As with any vaccine, TRUMENBA may not prevent disease in all vaccinated individuals. The frequency of meningococcal disease caused by serogroup B varies geographically, and could influence the ability to evaluate effectiveness of the vaccine in any given country. Based on the low incidence of meningococcal disease, placebo-controlled clinical trials for TRUMENBA were considered unfeasible due to the size of the study that would be required and were not performed. Licensure of TRUMENBA was based on demonstration of immune responses measured using a serum bactericidal assay with human complement (hSBA).
About Meningococcal B Disease
The majority of invasive meningococcal disease cases worldwide can be attributed to five Neisseria meningitidis serogroups (A, B, C, W and Y).8 In 2012, approximately 40 percent of all meningococcal disease cases in the U.S. were caused by serogroup B.9Meningococcal disease affects all age groups in the U.S., but incidence is highest among infants younger than one year, adolescents and young adults, and the elderly.10
Meningococcal disease may result in life-altering, significant long-term and permanent medical disabilities.11,12,13 Despite the availability of antibiotic treatment, between 10 and 15 percent of patients with meningococcal disease die and 11 to 19 percent of those who survive are afflicted with long-term disabilities, such as brain damage, hearing loss, learning disabilities or limb amputations.14
U.S. Indication for TRUMENBA® (meningococcal group B vaccine)
TRUMENBA (meningococcal group B vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years of age. Approval of TRUMENBA is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed.
Important Safety Information
  • TRUMENBA should not be given to anyone with a history of a severe allergic reaction after a previous dose of TRUMENBA.
  • Individuals with weakened immune systems may have a reduced immune response.
  • The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, and chills.
  • Data are not available on the safety and effectiveness of using TRUMENBA and other meningococcal group B vaccines interchangeably to complete the vaccination series.
  • Tell your healthcare provider if you are pregnant, or plan to become pregnant.
  • Ask your healthcare provider about the risks and benefits of TRUMENBA. Only a healthcare provider can decide if TRUMENBA is right for you or your child.
You are encouraged to report negative side effects of vaccines to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.
For the full prescribing information for TRUMENBA, please visit www.pfizer.com.
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.
DISCLOSURE NOTICE: The information contained in this release is as of October 29, 2014. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about TRUMENBA® (meningococcal group B vaccine), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of TRUMENBA; uncertainties regarding whether and when the CDC will make any potential recommendations regarding meningococcal group B vaccination; the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results; whether and when any biologics license applications may be filed in any jurisdictions other than the United States for TRUMENBA; whether and when any such other applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of TRUMENBA; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information That May Affect Future Results,” as well as in its subsequent reports on Form 8-K, all of which are filed with the SEC and available at www.sec.gov and www.pfizer.com.
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1 Sáfadi MAP, McIntosh EDG. Epidemiology and prevention of meningococcal disease: a critical appraisal of vaccine policies. Expert Rev Vaccines. 2011; 10: 1717-1730.
2 Poland GA. Prevention of meningococcal disease: current use of polysaccharide and conjugate vaccines. Clin Infect Dis. 2010; 50: S45-S53.
3 Jaslow, R. CBS News. Seventh possible meningitis case reported at Princeton University. November 11, 2013.http://www.cbsnews.com/news/seventh-possible-meningitis-case-reported-at-princeton-university/. Accessed October 27, 2014.
4 Landau, E. CNN.com. 3 meningococcal disease cases at Calif. college. http://www.cnn.com/2013/11/21/health/california-students-illness/. Updated November 21, 2013. Accessed October 27, 2014.
5 Hayes, A. CNN.com. Philadelphia meningitis death tied to Princeton outbreak. http://www.cnn.com/2014/03/18/health/drexel-meningitis-death/. Updated March 18, 2014. Accessed October 27, 2014.
6 Zauzmer, J. The Washington Post. Georgetown offering preventive antibiotics to close friends of meningitis victim. September 18, 2014. http://www.washingtonpost.com/local/education/georgetown-offering-preventive-antibiotics-to-close-friends-of-meningitis-victim/2014/09/18/d6831604-3fa7-11e4-b0ea-8141703bbf6f_story.html. Accessed October 27, 2014.
7 TRUMENBA® (meningococcal group B vaccine Prescribing Information, Pfizer, Inc. October 2014.
8 Pinto VB, Burden R, Wagner A, Moran EE, Lee C. The Development of an Experimental Multiple Serogroups Vaccine for Neisseria meningitidis. PLoS ONE. 2013; 8(11): 1-10.
9 Centers for Disease Control and Prevention. Active Bacterial Core Surveillance (ABCs) Report Emerging Infections Program Network -Neisseria meningitidis, 2012. http://www.cdc.gov/abcs/reports-findings/survreports/mening12.html. Accessed October 27, 2014.
10 Cohn A, MacNeil JR, Harrison LH, et al. Changes in Neisseria meningitidis disease epidemiology in the United States, 1998-2007: implications for prevention of meningococcal disease. Clin Infect Dis. 2010; 50: 184-191.
11 Borg J, Christie D, Coen PG, Pooy R, Viner RM. Outcomes of Meningococcal Disease in Adolescence: prospective, matched-cohort study. Pediatrics. 2009; 123: e502-e509.
12 Sabatini C, Bosis S, Semino M, Senatore L, Principi N, Esposito S. Clinical Presentation of Meningococcal Disease in Childhood. J Prev Med Hyg. 2012; 53: 116-119.
13 Brigham KS, Sandora TJ. Neisseria meningitidis: epidemiology, treatment and prevention in adolescents. Curr Opin Pediatr. 2009; 21: 437-443.
14 Centers for Disease Control and Prevention. Help Protect Your Preteen and Teen Against Meningococcal Disease.http://www.cdc.gov/features/meningococcal/. Last updated April 21, 2014. Accessed October 27, 2014.