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Wednesday, August 31, 2016

3 Things To Tell Every Customer

Your customer’s or prospect’s attention is extremely important to your business.  Let’s look at three statements you should be making and backing up to your customers.



3 Things To Tell Every Customer

Photo Release--Ingalls Shipbuilding Awarded $88.2 Million Advance Procurement Contract for a Ninth NSC

Photo Release--Ingalls Shipbuilding Awarded $88.2 Million Advance Procurement Contract for a Ninth NSC: PASCAGOULA, Miss., Aug. 30, 2016 (GLOBE NEWSWIRE) -- Huntington Ingalls Industries’ (NYSE:HII) Ingalls Shipbuilding division today received an $88.2 million fixed-price contract from the U.S. Coast Guard to purchase long-lead materials for a ninth National Security Cutter (NSC).


US Army awards Raytheon Long Range Precision Fires risk mitigation contract

TUCSON, Ariz.Aug. 23, 2016 /PRNewswire/ -- The U.S. Army has awarded Raytheon Company (NYSE: RTN) a $5.7 million risk-mitigation contract for the Long Range Precision Fires program.  The new missile will replace the Army's aging inventory of long range, surface-to-surface missiles. Fired from mobile launchers, LRPF will fly farther, faster, and feature a new warhead.

http://raytheon.mediaroom.com/2016-08-23-US-Army-awards-Raytheon-Long-Range-Precision-Fires-risk-mitigation-contract

Raytheon awarded up to $104 million to modernize ground controls for U.S. Air Force Global Hawk

DULLES, Va.Aug. 22, 2016 /PRNewswire/ -- Raytheon Company (NYSE: RTN) has been awarded a subcontract valued up to $104 million to modernize the ground segment for the U.S. Air Force RQ-4 Global Hawk autonomous aircraft. Raytheon partners with Northrop Grumman as the ground integrator for Global Hawk contracts.

http://raytheon.mediaroom.com/2016-08-22-Raytheon-awarded-up-to-104-million-to-modernize-ground-controls-for-U-S-Air-Force-Global-Hawk

Raytheon unveils Cyber and Electromagnetic Battle Management for U.S. Army

AUGUSTA, Ga.Aug. 22, 2016 /PRNewswire/ -- Raytheon Company (NYSE: RTN) showcased Cyber and Electromagnetic Battle Management, a new battle management tool, at Cyber Quest, a U.S. Army event that informs cybersecurity requirements and priorities. CEMBM integrates cyber and electromagnetic spectrum awareness capabilities into the Electronic Warfare Program Management Tool, an Army program of record since 2014.

http://raytheon.mediaroom.com/2016-08-22-Raytheon-unveils-Cyber-and-Electromagnetic-Battle-Management-for-U-S-Army

Northrop Grumman Demonstrates New Maritime Domain Awareness Capabilities at Annual US Navy Technology Exercise

NEWPORT, Rhode Island – Aug. 25, 2016 – Northrop Grumman Corporation (NYSE:NOC) demonstrated  new cross domain approaches for autonomous undersea, surface and air vehicles to advance the Anti-Submarine Warfare mission during this year’s Annual Naval Technology Exercise (ANTX) at Naval Undersea Warfare Center (NUWC) in Newport.

http://news.northropgrumman.com/news/releases/northrop-grumman-demonstrates-new-maritime-domain-awareness-capabilities-at-annual-us-navy-technology-exercise

Northrop Grumman Receives DOD James S. Cogswell Award for Outstanding Industrial Security Program

PALMDALE, Calif. – Aug. 23, 2016 – Northrop Grumman Corporation’s (NYSE: NOC) Palmdale facility received the prestigious James S. Cogswell Outstanding Industrial Security Achievement Award by the Defense Security Service (DSS) in an awards ceremony, Aug. 17. More than 13,000 defense contractors were eligible and only 42 received the Cogswell Award. 

http://news.northropgrumman.com/news/releases/northrop-grumman-receives-dod-james-s-cogswell-award-for-outstanding-industrial-security-program

Northrop Grumman Completes G/ATOR Block II Preliminary and Critical Design Reviews

BALTIMORE – Aug. 23, 2016 – Northrop Grumman Corporation (NYSE: NOC) and the U.S. Marine Corps have achieved two major milestones in developing the Ground Weapon Locating Radar (GWLR) mode for the AN/TPS-80 Ground/Air Task-Oriented Radar (G/ATOR).

http://news.northropgrumman.com/news/releases/northrop-grumman-completes-g-ator-block-ii-preliminary-and-critical-design-reviews

Medtronic, on Behalf of Its Subsidiary Heartware International, Inc., Announces Offer to Repurchase HeartWare's 3.50% Convertible Senior Notes Due 2017 and 1.75% Convertible Senior Notes Due 2021


http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2197677

Medtronic Reports First Quarter Financial Results

http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2197342

Medtronic Completes Acquisition of HeartWare International

DUBLIN - Aug. 23, 2016 - Medtronic plc (NYSE: MDT), the global leader in medical technology, has completed its acquisition of HeartWare International, Inc., a leading innovator of less-invasive, miniaturized, mechanical circulatory support technologies (MCS) for treating patients with advanced heart failure. HeartWare will become part of the Heart Failure business within the Medtronic Cardiac Rhythm and Heart Failure division. Under the terms of the transaction, each outstanding share of HeartWare common stock has been converted into the right to receive $58.00 in cash, without interest, subject to any required withholding of taxes.

http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2196837

Lockheed Martin, University of Colorado Boulder Create Multi-Million-Dollar Partnership

Boulder, Colo., Aug. 25, 2016 – Lockheed Martin (NYSE: LMT) and the University of Colorado Boulder (CU) are establishing new academic programs through a multi-million-dollar agreement that will develop the next generation of space engineers. The Lockheed Martin Radio Frequency (RF) Space Systems Research Center will boost engineering expertise at the school and create new curriculum to fill in-demand skills in the space sector.

http://www.lockheedmartin.com/us/news/press-releases/2016/august/ssc-space-goesr1.html

Lockheed Martin Names Greg Gardner Vice President, Investor Relations

Jerry Kircher to Retire at End of 2016

http://www.lockheedmartin.com/us/news/press-releases/2016/august/082516-vp-investor-gardner.html

Ooh Rah: U.S. Marine Corps Receives 50th KC-130J Super Hercules Aerial Refueler

MARIETTA, Georgia, Aug. 25, 2016 – The U.S. Marine Corps accepted delivery of its 50th KC-130J Super Hercules aerial refueler at the Lockheed Martin (NYSE: LMT) facility here on Aug. 18. This KC-130J is assigned to Marine Corps Air Station Miramar, California. The Marine Corps has the distinction of operating the largest KC-130J fleet in the world.

http://www.lockheedmartin.com/us/news/press-releases/2016/august/us-marine-corps-receives-50th-kc-130j-super-hercules-aerial-refueler.html

Lockheed Martin Delivers NOAA’s GOES-R Weather Satellite to Launch Site

DENVER, Aug. 23, 2016 – NOAA’s newest weather satellite, GOES-R, left its Colorado home where it was built and is now in Florida where it will undergo preparations for a Nov. 4 launch. Monday, Lockheed Martin (NYSE: LMT) shipped the next-generation satellite aboard an Air ForceC-5M Super Galaxy cargo transport plane to its Astrotech Space Operations facility in Titusville, Florida.

http://www.lockheedmartin.com/us/news/press-releases/2016/august/ssc-space-goesr.html

Lockheed Martin Awarded $79.5 Million Contract to Provide an Open Architecture Combat Management System for the U.S. Navy’s Frigates

MOORESTOWN, N.J., Aug. 23, 2016 – The U.S. Navy selected Lockheed Martin’s (NYSE: LMT) COMBATSS-21 as the combat management system for the Navy’s frigate ship program. COMBATSS-21 is the combat management system in operation on the Freedom variant Littoral Combat Ship (LCS). The five-year contract, which is worth up to $79.5 million, covers fiscal years 2016-2021.

http://www.lockheedmartin.com/us/news/press-releases/2016/august/160823-mst-79-5-million-contract-to-provide-open-architecture-combat-management-system-for-us-navys-frigates.html

Air Force, Lockheed Martin and Northrop Grumman Celebrate 100 Years of Flying Protected Satellite Communications

COLORADO SPRINGS, Colo., Aug. 23, 2016 – When it comes to transmitting sensitive information in highly contested areas, the Advanced Extremely High Frequency (AEHF) system and Milstar satellites are proving their value, achieving 100 years of combined successful operations.

http://www.lockheedmartin.com/us/news/press-releases/2016/august/ssc-082216-protected-comms.html

Lockheed Martin Announces Final Proration Factor

Lockheed Martin Announces Final Proration Factor of Approximately 8.05 Percent forShares Tendered in Exchange Offer for IT and Technical Services Businesses

http://www.lockheedmartin.com/us/news/press-releases/2016/august/082216-lockheed-martin-final-proration-leidos.html

Associated Aircraft Group Donates Helicopter Flights to Patient AirLift Services (PALS)

WAPPINGERS FALLS, NY – August 22, 2016  Sikorsky announced today that its Associated Aircraft Group (AAG) has partnered with Patient AirLift Services (PALS), a nonprofit organization that arranges for free volunteer aircraft flights for needy medical patients including military veterans throughout the Northeast. Sikorsky is a Lockheed Martin company (NYSE: LMT).

http://www.lockheedmartin.com/us/news/press-releases/2016/august/160822-mst-sikorsky-associated-aircraft-group-donates-helicopter-flights-to-patient-airlift-services.html

Spotlight: Bar-B-Clean Franchise Focuses on Cleaning and Maintenance of Barbecue Grills

Barbecue grills can be great for summer gatherings and everyday meals. But they can also get quite dirty and aren’t exactly easy to clean. A few years back, one enterprising entrepreneur decided that this somewhat messy niche could make for a great business opportunity. And Bar-B-Clean was born. Read more about the business below in this week’s Small Business Spotlight.



Spotlight: Bar-B-Clean Franchise Focuses on Cleaning and Maintenance of Barbecue Grills

Jamere Jackson Elected to Lilly Board of Directors (NYSE:LLY)

Jamere Jackson Elected to Lilly Board of Directors (NYSE:LLY)

Xiaomi Introduces Latest Example of Cheap Smartphone Trend with Redmi Note 4

The continuing trend of full-featured and cheap Chinese smartphones is disrupting the segment, as the sales of premium flagship brands keeps declining. While the Xiaomi Redmi Note 4 is not as cheap as theZTE Zmax, which came in at $99, its $239.99 and $179.99 price tags are still considerably lower than the high-end versions. This is welcomed news for small businesses looking to integrate mobility as part of their overall collaborative and remote workforce initiatives.



Xiaomi Introduces Latest Example of Cheap Smartphone Trend with Redmi Note 4

XALKORI® (Crizotinib) Receives Approval In European Union For The Treatment Of Patients With ROS1-Positive Advanced Non-Small Cell Lung Cancer

From Pfizer:


XALKORI® (Crizotinib) Receives Approval In European Union For The Treatment Of Patients With ROS1-Positive Advanced Non-Small Cell Lung Cancer

XALKORI is the first and only approved biomarker-driven therapy for ROS1-positive advanced NSCLC in the EU
Wednesday, August 31, 2016 7:00 am EDT

Dateline:

NEW YORK

Public Company Information:

NYSE:
PFE
US7170811035
"Forward-Looking Information and Factors That May Affect Future Results"
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved XALKORI® (crizotinib) for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC). In the European Union (EU), XALKORI is also indicated for treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced NSCLC. In March of this year, XALKORI was approved by the United States (U.S.) Food and Drug Administration for patients with metastatic NSCLC whose tumors are ROS1-positive. With this approval, XALKORI becomes the only biomarker-driven therapy approved for patients with either ALK positive or ROS1-positive advanced NSCLC in the EU and U.S.
“The European Commission’s decision to approve XALKORI for ROS1-positive advanced NSCLC represents an important milestone for patients who previously had limited treatment options,” said Andreas Penk, MD, Regional President, International Developed Markets, Pfizer Oncology. “We now know that NSCLC is not a single disease, but includes a number of molecularly defined tumors with different clinical characteristics and treatment options. With EU approvals in two distinct molecular targets in advanced NSCLC, ROS1 and ALK, XALKORI continues to break new ground and exemplify our commitment to precision drug development and patients.”
The European Commission’s approval of XALKORI in patients with ROS1-positive advanced NSCLC follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine’s Agency, and is supported by compelling results from a multicenter, single-arm Phase 1 study (Study 1001) that included patients with ROS1-positive advanced NSCLC treated with 250 mg of XALKORI orally twice daily.
The efficacy outcome measure in this study was objective response rate (ORR) by RECIST. Secondary endpoints included time to tumor response (TTR), duration of response (DOR) and progression-free survival (PFS). Tumors were tested for ROS1 rearrangements by laboratory-developed break-apart fluorescence in situ hybridization (FISH) (96%) or real-time polymerase chain reaction (RT-PCR) (4%) assay.1
The results of this study showed that XALKORI exhibited marked anti-tumor activity in patients with ROS1-positive advanced NSCLC and met its primary endpoint of ORR. Additionally, the safety profile of XALKORI in ROS1-positive advanced NSCLC was generally consistent with that observed in patients with ALK-positive advanced NSCLC.1 The updated data set used to support this approval will be presented at a future medical meeting.
XALKORI is widely recognized as a first-line standard of care for patients with ALK-positive advanced NSCLC. XALKORI was the first ALK inhibitor approved by regulatory authorities in the U.S., EU, China and Japan, and it is now approved in nearly 90 countries. To date, more than 25,000 patients have been treated with XALKORI worldwide.2
ROS1 rearrangements occur when the ROS1 gene attaches to another gene and changes the way each gene normally functions, which can contribute to cancer-cell growth. Epidemiology data suggest that ROS1 rearrangements occur in approximately one percent of NSCLC cases.3 Of the estimated 1.5 million new cases of NSCLC worldwide each year, roughly 15,000 may be driven by oncogenic ROS1 fusions.2,4,5
About Non-Small Cell Lung Cancer
Worldwide, lung cancer is the leading cause of cancer death in both men and women.6 NSCLC accounts for about 85 percent of lung cancer cases and remains difficult to treat, particularly in the metastatic setting.7 Approximately 57 percent of NSCLC patients are diagnosed late with metastatic, or advanced, disease where the five-year survival rate is only 5 percent.8
XALKORI ® (crizotinib) Indications and Important Safety Information (as per U.S. Prescribing Information)
XALKORI is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. XALKORI is also indicated for the treatment of patients with metastatic NSCLC whose tumors are ROS1-positive.
Hepatotoxicity: Drug-induced hepatotoxicity with fatal outcome occurred in 0.1% of patients treated with XALKORI across clinical trials (n=1719). Transaminase elevations generally occurred within the first 2 months. Monitor with liver function tests including ALT, AST, and total bilirubin every 2 weeks during the first 2 months of treatment, then once a month and as clinically indicated, with more frequent repeat testing for increased liver transaminases, alkaline phosphatase, or total bilirubin in patients who develop transaminase elevations. Permanently discontinue for ALT/AST elevation >3 times ULN with concurrent total bilirubin elevation >1.5 times ULN (in the absence of cholestasis or hemolysis); otherwise, temporarily suspend and dose-reduce XALKORI as indicated.
Interstitial Lung Disease (Pneumonitis): Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis can occur. Across clinical trials (n=1719), 2.9% of XALKORI-treated patients had any grade ILD, 1.0% had Grade 3/4, and 0.5% had fatal ILD. ILD generally occurred within 3 months after initiation of treatment. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Exclude other potential causes and permanently discontinue XALKORI in patients with drug-related ILD/pneumonitis.
QT Interval Prolongation: QTc prolongation can occur. Across clinical trials (n=1616), 2.1% of patients had QTcF (corrected QT by the Fridericia method) ≥500 ms and 5.0% had an increase from baseline QTcF ≥60 ms by automated machine-read evaluation of ECGs. Avoid use in patients with congenital long QT syndrome. Monitor with ECGs and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or who are taking medications that prolong the QT interval. Permanently discontinue XALKORI in patients who develop QTc >500 ms or ≥60 ms change from baseline with Torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmia. Withhold XALKORI in patients who develop QTc >500 ms on at least 2 separate ECGs until recovery to a QTc ≤480 ms, then resume at a reduced dose.
Bradycardia: Symptomatic bradycardia can occur. Across clinical trials, bradycardia occurred in 12.7% of patients treated with XALKORI (n=1719). Avoid use in combination with other agents known to cause bradycardia. Monitor heart rate and blood pressure regularly. In cases of symptomatic bradycardia that is not life-threatening, hold XALKORI until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm, re-evaluate the use of concomitant medications, and adjust the dose of XALKORI. Permanently discontinue for life-threatening bradycardia due to XALKORI; however, if associated with concomitant medications known to cause bradycardia or hypotension, hold XALKORI until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If concomitant medications can be adjusted or discontinued, restart XALKORI at 250 mg once daily with frequent monitoring.
Severe Visual Loss: Across clinical trials, the incidence of Grade 4 visual field defect with vision loss was 0.2% (n=1719). Discontinue XALKORI in patients with new onset of severe visual loss (best corrected vision less than 20/200 in one or both eyes). Perform an ophthalmological evaluation. There is insufficient information to characterize the risks of resumption of XALKORI in patients with a severe visual loss; a decision to resume should consider the potential benefits to the patient.
Vision Disorders: Most commonly visual impairment, photopsia, blurred vision or vitreous floaters, occurred in 63.1% of 1719 patients. The majority (95%) of these patients had Grade 1 visual adverse reactions. 0.8% of patients had Grade 3 and 0.2% had Grade 4 visual impairment. The majority of patients on the XALKORI arms in Studies 1 and 2 (>50%) reported visual disturbances which occurred at a frequency of 4-7 days each week, lasted up to 1 minute, and had mild or no impact on daily activities.
Embryo-Fetal Toxicity: XALKORI can cause fetal harm when administered to a pregnant woman. Advise of the potential risk to the fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least 45 days (females) or 90 days (males) respectively, following the final dose of XALKORI.
ROS1-positive Metastatic NSCLC: Safety was evaluated in 50 patients with ROS1-positive metastatic NSCLC from a single-arm study, and was generally consistent with the safety profile of XALKORI evaluated in patients with ALK-positive metastatic NSCLC. Vision disorders occurred in 92% of patients in the ROS1 study; 90% of patients had Grade 1 vision disorders and 2% had Grade 2.
Adverse Reactions: Safety was evaluated in a phase 3 study in previously untreated patients with ALK-positive metastatic NSCLC randomized to XALKORI (n=171) or chemotherapy (n=169). Serious adverse events were reported in 34% of patients treated with XALKORI, the most frequent were dyspnea (4.1%) and pulmonary embolism (2.9%). Fatal adverse events in XALKORI-treated patients occurred in 2.3% of patients, consisting of septic shock, acute respiratory failure, and diabetic ketoacidosis. Common adverse reactions (all grades) occurring in ≥25% and more commonly (≥5%) in patients treated with XALKORI vs chemotherapy were vision disorder (71% vs 10%), diarrhea (61% vs 13%), edema (49% vs 12%), vomiting (46% vs 36%), constipation (43% vs 30%), upper respiratory infection (32% vs 12%), dysgeusia (26% vs 5%), and abdominal pain (26% vs 12%). Grade 3/4 reactions occurring at a ≥2% higher incidence with XALKORI vs chemotherapy were QT prolongation (2% vs 0%), and constipation (2% vs 0%). In patients treated with XALKORI vs chemotherapy, the following occurred: elevation of ALT (any grade [79% vs 33%] or Grade 3/4 [15% vs 2%]); elevation of AST (any grade [66% vs 28%] or Grade 3/4 [8% vs 1%]); neutropenia (any grade [52% vs 59%] or Grade 3/4 [11% vs 16%]); lymphopenia (any grade [48% vs 53%] or Grade 3/4 [7% vs 13%]); hypophosphatemia (any grade [32% vs 21%] or Grade 3/4 [10% vs 6%]). In patients treated with XALKORI vs chemotherapy, renal cysts occurred (5% vs 1%). Nausea (56%), decreased appetite (30%), fatigue (29%), and neuropathy (21%) also occurred in patients taking XALKORI.
Drug Interactions: Exercise caution with concomitant use of moderate CYP3A inhibitors. Avoid grapefruit or grapefruit juice which may increase plasma concentrations of crizotinib. Avoid concomitant use of strong CYP3A inducers and inhibitors. Avoid concomitant use of CYP3A substrates with narrow therapeutic range in patients taking XALKORI. If concomitant use of CYP3A substrates with narrow therapeutic range is required in patients taking XALKORI, dose reductions of the CYP3A substrates may be required due to adverse reactions.
Lactation: Because of the potential for adverse reactions in breastfed infants, advise females not to breast feed during treatment with XALKORI and for 45 days after the final dose.
Hepatic Impairment: XALKORI has not been studied in patients with hepatic impairment. As crizotinib is extensively metabolized in the liver, hepatic impairment is likely to increase plasma crizotinib concentrations. Use caution in patients with hepatic impairment.
Renal Impairment: Administer XALKORI at a starting dose of 250 mg taken orally once daily in patients with severe renal impairment (CLcr <30 mL/min) not requiring dialysis. No starting dose adjustment is needed for patients with mild and moderate renal impairment.
For more information and full Prescribing Information, visit www.XALKORI.com.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options to improve the outlook for cancer patients worldwide. Our strong pipeline of biologics and small molecules, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments, and licensing partners, Pfizer Oncology strives to cure or control cancer with breakthrough medicines, to deliver the right drug for each patient at the right time. For more information, 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 healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer healthcare 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. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at@Pfizer and @Pfizer_NewsLinkedIn,YouTube, and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is as of August 31, 2016. 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 a new indication for XALKORI (crizotinib) for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (the “new indication”), 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, the uncertainties inherent in research and development; uncertainties regarding the commercial success of XALKORI for the new indication; whether and when any applications may be filed with other regulatory authorities for XALKORI for the new indication; whether and when other regulatory authorities may approve any applications to extend the marketing authorization of XALKORI to include the new indication, 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 XALKORI; 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, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at  www.sec.gov and  www.pfizer.com .
# # # # #
1 Shaw AT et al. Crizotinib in ROS1-Rearranged Non-Small Cell Lung Cancer. The New England Journal of Medicine. 2014: 371; 21: 1963-1971.
2 Pfizer. Data on file.
3 Gainor JF, Shaw AT. Novel targets in non-small cell lung cancer: ROS1 and RET fusions. Oncologist 2013;18:865-75.
4 American Cancer Society. Detailed Guide: What is Lung Cancer – Non-Small Cell? Available at:http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer. Accessed March 16, 2015.
5 World Health Organization. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Available at: http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Accessed December 29, 2015.
6 The International Agency for Research on Cancer, the World Health Organization, GLOBOCAN 2012, Available at:http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Accessed October 15, 2015.
7 Reade CA, Ganti AK. EGFR targeted therapy in non-small cell lung cancer: potential role of cetuximab. Biologics. 2009; 3: 215 224.
8 National Cancer Institute. Surveillance, Epidemiology, and End Results Program. Seer Stat Fact Sheets: Lung and Bronchus Cancer.http://seer.cancer.gov/statfacts/html/lungb.html. Accessed October 15, 2015.

Want to Change Your Company’s Name? Here’s How

One question that small business owners commonly ask is how to change their business name. It’s only natural for a business to grow, evolve or change direction over the course of its lifetime. The name you hatched in the early days may no longer fit your business’ market, activities or brand personality now. The question is: is there an easy way to officially change the business’ name without having to start all over again?
From a legal perspective, the process of changing a name is more involved than just notifying your customers and changing your marketing material. However, it isn’t as complicated as you might think. The specific steps depend on how you are operating your business: are you a sole proprietor or an LLC/corporation. We’ll cover both situations in this article.


Want to Change Your Company’s Name? Here’s How

Interview with US Trade Representative on TTIP - SPIEGEL ONLINE

German Vice Chancellor Sigmar Gabriel recently claimed negotiations over the planned trans-Atlantic free trade agreement had fallen apart. US Trade Representative Michael Froman says that's incorrect and argues now is the time for unity.



Interview with US Trade Representative on TTIP - SPIEGEL ONLINE

10 Tips to Improve Your Writing Skills

After the years we spend learning to write formally for academia, content writing at first seems a little unnatural, mainly because blog writing lends itself to a certain brevity and casualness in both style and tone. What I’ve found is true for me as well as other bloggers is that proofreading and editing can also take on a quick, casual manner, often hinging on sloppy.
When you’re focused on meeting deadlines and cranking out strong content, editing, proofreading, and refining the writing process can get pushed onto the backburner. But part of producing strong, quality content is ensuring that it’s clear of the errors and clumsy wording that tends to seep into writing. Sometimes weeding out those mistakes is simply a matter of getting back to basics, so try refining your writing and editing process with these 10 easy tips.


10 Tips to Improve Your Writing Skills

As the Job Market Heats Up, Consider These Bonuses to Keep Employees Happy

A bonus is additional compensation paid to an employee. As the job market heats up, the competition among employers to attract and retain good workers is growing. Bonuses may be a way for your company to gain a competitive edge in the job market. This is especially true for small businesses that may not offer the same menu of fringe benefits that large corporations do.



As the Job Market Heats Up, Consider These Bonuses to Keep Employees Happy

Coca-Cola's Water Replenishment Effort Succeeds - and Fails (Watch)

Coca-Cola is giving back — water, that is. Ten years ago, the company pledged to replenish all of the water it used in its finished beverages. And it has now completed that goal about five years early.
But not everyone is impressed. Advocacy groups have criticized Coca-Cola for only replenishing the water used in its finished beverages, and not the water that it used in the manufacturing process. In the past, groups have also accused Coca-Cola of unethically taking water from communities that were already experiencing water shortages.


Coca-Cola's Water Replenishment Effort Succeeds - and Fails (Watch)

RMA Engages Farmers at Annual Meeting of Southern Grassroots Cooperatives

From the USDA:


Michael Alston speaking
Michael Alston speaking about the safety net RMA offers farmers and ranchers through crop insurance.
Recently, I had the honor of representing USDA at the annual Federation of Southern Cooperatives and Land Assistance Fund (FSCLA) annual meeting in Epes, Ala. It gave me a chance to speak with a phenomenal group of hardworking farmers and ranchers, to hear their stories and share some of the improvements that USDA, under the Obama Administration, has put in place to help uproot inequality. Over the past eight years, we’ve taken steps to change the culture of USDA to ensure all Americans who come to us for help are treated fairly, with dignity and respect.
As I stepped to the podium and looked out at a crowd of faces that resembled mine, I thought back to my early childhood growing up on my parent’s farm.  I remembered the hardships they endured trying to sustain a life for me and my siblings, and I wished that I could have offered the same information and opportunities to them as I was about to provide to the room full of individuals at the meeting.
The audience of small farmers and ranchers were no different from my parents; they were hardworking people trying to sustain themselves as well as their land and looking for ways to do it. Our mission at the Risk Management Agency (RMA) is to provide resources and educational tools to help farmers and ranchers effectively manage long-term risks and challenges. I stressed to them what I have learned though my years at USDA, and that is to treat your farm as a business, and one way to do that is by making an informed decision to purchase crop insurance and mitigate risk.
I made it my mission to introduce the USDA’s stand on providing crop insurance for beginning farmers of all backgrounds, and risk management solutions that provide a farm safety net that works for them. Conveying the importance of crop insurance and inspiring producers to make educated decisions as far as mitigating their risk is one of the many contributions that I can make for growers who need assistance.
RMA offers various coverage options to organic producers as well as those farmers who have small farms or produce specialty crops. Through efforts such as StrikeForce, we provide support in high-poverty areas in rural America and through policies like Whole-Farm Revenue Protection (WFRP) we can offer a great option for small to mid-size farmers and ranchers, especially those growing a diversified set of crops and animals. The WFRP program provides a risk management safety net for all commodities on a farm under one insurance policy. This insurance policy is ideal for the types of farms the audience had; and the kind of safety net option farms with specialty or organic commodities, or those marketing to local, regional, farm-identity preserved, specialty, or direct markets have been asking for. And it is available in every county of every state.
The event marked the FSCLA’s 49th anniversary celebration. A celebration that contributes support toward the federation’s ongoing efforts to promote social and economic equity through cooperative economic development, land retention, and advocacy. It was rewarding to tell the audience how RMA has made efforts to support a diverse farm community, and to ensure the farm safety net we provide works for those across the social and economic spectrum.
Participants in the FSC Annual Meeting
Participants in the FSC Annual Meeting. The annual meeting offered attendees a variety of exhibits, workshops, trainings, live auctions, panel discussions, and entertainment.

UnitedHealth Group - $12 Million Investment by UnitedHealthcare Helps Bring New Affordable-Housing Community to Downtown Albuquerque

UnitedHealth Group - $12 Million Investment by UnitedHealthcare Helps Bring New Affordable-Housing Community to Downtown Albuquerque

What Is Influencer Marketing and How Can It Help My Business?

Influencer marketing is a growing trend and a tactic that you should consider adding to your marketing mix.
While it’s unlikely you’ll be hiring Kim Kardashian to represent your brand anytime soon, everyone has some degree of influence, and many will talk about your company, products and services, provided you offer the right incentive.


What Is Influencer Marketing and How Can It Help My Business?

5 Little-Known Sales Skills that Entrepreneurs Should Master

Aren’t you tired of the same old sales tips?
I can’t blame you. There’s so many different sales techniques that entrepreneurs can use to gain more business. It can be hard to determine which ones work the best.


5 Little-Known Sales Skills that Entrepreneurs Should Master

Garmin Changes Smartwatch from Geek Gadget to Status Symbol

Smartwatches are still somewhat of a niche product, but that hasn’t stopped manufacturers from creating premium versions with some hefty price tags. The Fenix Chronos by Garmin (NASDAQ:GRMN) takes the proven and highly acclaimed functionality of the  company’s Fenix 3 line of smartwatches and adds some luxury for high-end customers.



Garmin Changes Smartwatch from Geek Gadget to Status Symbol

Facebook Introduces Text, Music Other Features to Slideshow Ads

In a bid to improve its ad features, Facebook (NASDAQ:FB) has announced a number of improvement to the platform’s Slideshow ads tool.
Facebook first announced Slideshow ads last October, launching the program on both Facebook and Instagram.


Facebook Introduces Text, Music Other Features to Slideshow Ads

Tuesday, August 30, 2016

European Union Waging War On Companies | Power Lunch | CNBC

The 'LoweBot' Will Help You Find What You're Looking For: Bottom Line | ...

Johnson & Johnson to Participate in the 2016 Wells Fargo 11th Annual Healthcare Conference


http://www.jnj.com/news/all/Johnson-Johnson-to-Participate-in-the-2016-Wells-Fargo-11th-Annual-Healthcare-Conference

Ethicon Announces Strategic Collaboration With Touch Surgery to Evolve Medical Education

Somerville, NJ, August 22, 2016 -- Ethicon, Inc., part of the Johnson & Johnson Medical Devices Companies, announces a strategic collaboration with Touch Surgery to help improve patient outcomes by delivering simulated surgical training based on the safe and efficacious use of Ethicon products in a free mobile app that can reach medical professionals in even remote regions of the world.  

http://www.jnj.com/news/all/Ethicon-Announces-Strategic-Collaboration-With-Touch-Surgery-to-Evolve-Medical-Education

For U.S. Media Only: Janssen Announces 25 Presentations at Upcoming ESC Congress 2016, Including New Clinical and Real-World Research on XARELTO® and Latest Findings from REVISIT-US

RARITAN, NJ (August 22, 2016) – Janssen Pharmaceuticals, Inc., today announced that 25 abstracts have been accepted for presentation by Janssen and its development partner, Bayer, at the ESC Congress 2016, taking place August 27-31 in Rome, Italy. New real-world evidence from the EXPLORER research program, including latest findings from the REVISIT-US study, will address how XARELTO® (rivaroxaban), a non-vitamin K antagonist oral anticoagulant (NOAC), is performing in routine clinical practice. Also, the companies will unveil the design of the GALILEO trial, which seeks to address blood clot prevention for patients following successful transcatheter aortic valve replacement (TAVR). 

http://www.jnj.com/news/all/Janssen-Announces-25-Presentations-at-Upcoming-ESC-Congress-2016-Including-New-Clinical-and-Real-World-Research-on-XARELTO-and-Latest-Findings-from-REVISIT-US

Honeywell To Present At Vertical Research Partners Industrials Conference


http://www.honeywell.com/newsroom/pressreleases/2016/08/honeywell-to-present-at-vertical-research-partners-industrials-conference

Honeywell Hardware Awarded Final Certification For Inmarsat's Next-Generation GX Aviation In-Flight Wi-Fi

PHOENIXAug. 23, 2016 /PRNewswire/ -- Honeywell (NYSE: HON) achieved final certification from Inmarsat for JetWave™, the company's package of exclusive hardware that will allow pilots, passengers, operators and maintenance personnel to connect to GX Aviation, the revolutionary new in-flight broadband service from Inmarsat. Users can consistently and more quickly surf the internet, check emails, stream music and videos, and shop online without drop-off throughout their flight, even when flying over oceans.

http://www.honeywell.com/newsroom/pressreleases/2016/08/honeywell-hardware-awarded-final-certification-for-inmarsats-next-generation-gx-aviation-in-flight-wi-fi

GSK’s continued commitment to innovative respiratory research demonstrated in European Respiratory Society congress data presentations

GlaxoSmithKline plc (GSK) will provide updates on emerging areas of research with data from across its comprehensive respiratory portfolio of approved medicines, investigational programmes and scientific collaborations, at the European Respiratory Society (ERS) International Congress, 3rd -7th  September, London, UK. More than 30 abstracts from the company will be featured at the meeting.                                                                              
Highlights include data from a number of key studies:

Kelly A. Kramer Joins Gilead Sciences’ Board of Directors

From Gilead Sciences:


Kelly A. Kramer Joins Gilead Sciences’ Board of Directors

FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 23, 2016-- Gilead Sciences, Inc. (Nasdaq:GILD) announced today that Kelly A. Kramer has been appointed to the company’s Board of Directors and Audit Committee.
Ms. Kramer is currently Executive Vice President and Chief Financial Officer of Cisco Systems, Inc., which designs and sells products, services and solutions to securely connect everyone and everything. She previously served for 20 years in senior finance positions at General Electric, including as Chief Financial Officer of GE Healthcare’s Healthcare Systems Business. She is a member of the board of theSilicon Valley Chapter of City Year, a non-profit organization that provides educational support for at-risk students in poor communities.
“We are very pleased to welcome Kelly Kramer to the Board of Directors of Gilead Sciences,” said John Martin, PhD, Executive Chairman of Gilead’s Board of Directors. “Kelly’s deep financial expertise in the technology and healthcare industries, including mergers and acquisitions, will be valuable as Gilead continues to grow across multiple therapeutic areas and around the world. I look forward to the contributions and insights that she will bring to the Board.”
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

European Commission Grants Marketing Authorization for Gilead’s Once-Daily Truvada® For Reducing the Risk of Sexually Acquired HIV-1

From Gilead Sciences:


European Commission Grants Marketing Authorization for Gilead’s Once-Daily Truvada® For Reducing the Risk of Sexually Acquired HIV-1

– Truvada is the First Antiretroviral Medicine to be Licensed in Europe for Pre-Exposure Prophylaxis, in Combination with Safer-Sex Practices, to Reduce the Risk of Sexually Acquired HIV-1 in Adults at High Risk –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 22, 2016-- Gilead Sciences, Inc.(Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for once-daily Truvada® (emtricitabine 200 mg/tenofovir disoproxil 245 mg; FTC/TDF) in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP. Truvada was approved by theEuropean Medicines Agency in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults aged 18 years and over, and is currently the most prescribed antiretroviral medicine in Europe as part of combination therapy.
The marketing authorization allows for the marketing of Truvada for PrEP in all 28 countries of the European Union, subject to national regulatory authority approval of required pharmacovigilance materials in each country.
“In the past 30 years, we have seen significant progress in the way we treat HIV; however, infection rates have continued to rise. In 2014, we saw the highest number of newly diagnosed cases in the European Union ever recorded, with 94 percent of those with known cause transmitted through sexual contact,” said Professor Jean-Michel Molina, MD, PhD, Hôpital Saint Louis in Paris and University of Paris 7. “Truvada for PrEP provides an additional prevention tool, which when used with safer-sex practices, will help uninfected adults at high risk of HIV protect themselves against the virus.”
The marketing authorization is based on the results of two large placebo-controlled trials of Truvada, the Pre-Exposure Prophylaxis Initiative (iPrEX) and Partners PrEP, sponsored by the U.S. National Institutes of Health and the University of Washington, respectively. In these studies, the most commonly reported side effects included headache, stomach discomfort and weight loss. The incidence and types of side effects were consistent with Truvada’s safety and tolerability profile when used as part of an HIV treatment regimen.
“The approval of Truvada for PrEP represents an important step forward in addressing the incidence of HIV in Europe” said Norbert W. Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer,Gilead Sciences. “When taken as directed and used in combination with other prevention strategies, Gilead believes Truvada for PrEP can have a meaningful impact on public health by helping to reduce HIV transmission rates across Europe.”
Worldwide, clinical guidelines support the use of PrEP, in combination with other existing prevention measures such as condoms, to prevent the sexual transmission of HIV in adults at high risk of HIV infection. Truvada should not be used in individuals with unknown or positive HIV-1 status, as Truvada alone does not constitute a complete regimen for the treatment of HIV-1 and HIV-1 resistance mutations have emerged in individuals with undetected HIV-1 infection who are only taking Truvada.
In addition to the European Union, Truvada is also authorized for PrEP in Australia,CanadaKenyaPeruSouth Africa and the United States.
For important safety information for Truvada, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC, available from the EMA website atwww.ema.europa.eu.
About Gilead
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing Truvada for PrEP. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Boeing Delivers Advanced Satellite Communications Network to Mexico

Communications system enables voice and data services to all regions of the country

http://boeing.mediaroom.com/2016-08-25-Boeing-Delivers-Advanced-Satellite-Communications-Network-to-Mexico