ZDNet: Hispalinux has released the details of its complaint to the EC over Windows 8’s UEFO Secure Boot, and says getting rid of it is just too complex for the average user.
Tag Archives: EC
Ken Fisher Buys Apple Inc, American Express Co, Coinstar, Sells America Movil, Petrobras, Visa
By GuruFocus, Contributor We have just updated the portfolio of Ken Fisher. He buys Apple Inc, Basf SE, American Express Co, McDonald’s Corporation, Rio Tinto PLC, BP etc. As of 03/31/2013, Fisher Asset Management, LLC owns 483 stocks with a total value of $37.6 billion. These are the details of the buys and sells that have the impact to portfolio of more than .1%. New Purchases: CSTR, VSH, VALE.P, Added Positions: AAPL, BASFY, AXP, MCD, RIO, BP, CSCO, JPM, MTU, RHHBY, Reduced Positions: AMX, PBR, V, BIDU, EC, VALE, BRGYY, EAT, Sold Out: KMTUY, MW, For the details of Ken Fisher’s stock buys and sells, go to http://www.gurufocus.com/StockBuy.php?GuruName=Ken+Fisher
4 Surprising Stocks That Missed the Dow's Record High
By Dan Caplinger, The Motley Fool
Filed under: Investing
It took a while, but the Dow Jones Industrials finally warmed up to the start of earnings season by rising 60 points and setting a new all-time record high. Yet even though anxiety about the huge bull-market run that stocks have enjoyed since 2009 has some investors considering whether they ought to take profits and run, today’s market action shows a surprising dynamic that is a big shift from more normal investor behavior.
Ordinarily, with markets at new highs, worried investors would bid up shares of consumer giants. Yet many of the Dow’s top consumer companies finished lower today. Procter & Gamble fell two-thirds of a percent, while Coca-Cola backed off a 52-week high to finish lower by 0.4%. Both companies generally have defensive characteristics that worried investors typically like, as their businesses aren’t very sensitive to changing economic conditions, and they sell products that have relatively inelastic demand. Yet both stocks trade at above-market valuations, and recent concerns about Coke’s sales-volume challenges and P&G’s product miscues have conservative investors feeling less secure about their ability to withstand a market reversal.
Meanwhile, it was tech stocks — far from the usual favorite among defensive investors — that finished with huge gains. Although the Dow’s tech components can point to news to justify part of their gains, investors are also gravitating to their cheap valuations as providing a margin of safety in the event of a future downturn.
McDonald’s , also a defensive favorite, had its own problems today, falling from new highs to end down 0.4%. For the fast-food giant, an outbreak of bird flu in China could lead to reduced numbers of customers in the emerging nation, which has been an important part of the McDonald’s growth story in recent years. Reported price cuts could help, but they might also merely exacerbate sales declines by trimming margins and leading to further weakness.
Finally, American Express fell more than half a percent after the European Commission said it’s looking at a couple of card networks that target the continent to see if there are anticompetitive practices involved in the fees they charge and the agreements they have with merchants. AmEx wasn’t specifically mentioned, but given its growth ambitions, it faces many of the same issues as its rivals and could potentially face the same issues that the EC mentioned.
McDonald’s turned in a dismal year in 2012, underperforming the broader market by 25 percentage points. Looking ahead, can the fast-food giant reclaim its throne atop the restaurant industry, or will this unsettling trend continue? Our top analyst weighs in on McDonald’s future in a recent premium report on the company. Click here now find out whether a buying opportunity has emerged for this global juggernaut.
Source: FULL ARTICLE at DailyFinance
Seattle Genetics and Collaborators Highlight Multiple Antibody-Drug Conjugate (ADC) Programs and Tec
By Business Wirevia The Motley Fool
Filed under: Investing
Seattle Genetics and Collaborators Highlight Multiple Antibody-Drug Conjugate (ADC) Programs and Technology Advances at AACR
– Presentations Highlight Preclinical Data for Novel SGN-CD33A and SGN-LIV1A Programs and Breakthroughs in Research to Develop Highly Stable Linkers and More Potent Chemotypes –
– AACR Highlights Phase 1 Data for Genentech’s DMUC5754A, an ADC for Ovarian Cancer Utilizing Seattle Genetics’ Technology –
BOTHELL, Wash.–(BUSINESS WIRE)– Seattle Genetics, Inc. (NAS: SGEN) today announced that research related to its antibody-drug conjugate (ADC) technology was presented in multiple sessions at the 104th Annual Meeting of the American Association for Cancer Research (AACR) being held in Washington, D.C. Three data presentations highlight the rapid progress being made in ADC technology and testing. This includes preclinical data evaluating ADCs using a potent and newly developed cytotoxic agent, pyrrolobenzodiazepine (PBD) dimer, against two targets, CD33 and CD70. The former, SGN-CD33A, is expected to be advanced into a phase 1 clinical trial in 2013 for patients with acute myeloid leukemia (AML). In addition, preclinical data demonstrate activity of a new ADC for metastatic breast cancer, SGN-LIV1A, utilizing the same proprietary ADC technology as ADCETRIS® (brentuximab vedotin). The company also presented research on a novel method for making highly stable linkers, an advance that is being evaluated for potential future ADCs. In addition, many of the company’s collaborators, including Genentech, Pfizer, Progenics and Genmab, are reporting preclinical and clinical data from multiple ADC programs utilizing Seattle Genetics‘ proprietary ADC technology.
“As the leader in developing ADCs for the treatment of cancer, we are focused on both the current and future technology of this important class of therapeutics. More than half of the ADCs currently in clinical development utilize our technology, and we continue to advance additional candidates, such as SGN-CD33A and SGN-LIV1A, at a rapid pace. We are also looking at ways to enhance the next generation of ADCs, and believe that new potent cytotoxic agents such as PBD dimers, advances in antibody technology such as engineered cysteine antibodies (EC-mAbs), and highly stable linkers are part of that future,” said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine at Seattle Genetics. “We are driven to test these ADC advances quickly because cancer patients need new options to fight this relentless disease.”
ADCs are designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. …read more
Source: FULL ARTICLE at DailyFinance
Guru Stocks at 52-Week Lows: AAPL, EC, EMC, BIDU, APA
By GuruFocus, Contributor According to the GuruFocus list of 52-week lows, these stocks have reached their 52-week lows. …read more
Source: FULL ARTICLE at Forbes Latest
Guru Stocks at 52-Week Low: EC, ABX, PKX, MT, EQR
By GuruFocus, Contributor According to GuruFocus’ list of 52-week lows, these Guru stocks have reached their 52-week lows. …read more
Source: FULL ARTICLE at Forbes Latest
Pfizer's BOSULIF® (bosutinib) Receives Conditional Marketing Authorization From The European Commiss
By Business Wirevia The Motley Fool
Filed under: Investing
Pfizer’s BOSULIF® (bosutinib) Receives Conditional Marketing Authorization From The European Commission
NEW YORK–(BUSINESS WIRE)– Pfizer Inc. announced today that the European Commission (EC) has granted conditional marketing authorization for BOSULIF® (bosutinib) in the European Union (EU) for the treatment of adult patients with chronic phase (CP), accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.1
“I’m delighted the EC has approved BOSULIF as a new addition to the CML treatment landscape in Europe,” said Carlo Gambacorti-Passerini, MD, Professor of Internal Medicine at the University of Milano Bicocca in Italy, Director of the Clinical Research Unit, Section of Hematology at S. Gerardo Hospital in Monza, Italy, and a lead investigator in the BOSULIF clinical study. “It’s critical to have additional treatment options for CML patients, because each patient responds to therapy differently and has unique needs. Based on my experience with BOSULIF, I believe this once-daily treatment, with its distinct safety profile, offers an important new alternative.”
Conditional marketing authorizations in the EU are granted to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. As part of the conditional approval, Pfizer is committed to generating additional efficacy and safety data for BOSULIF in patients with Ph+ CML previously treated with one or more TKIs not suitable for imatinib, dasatinib and nilotinib, and will submit the findings to the European Medicines Agency (EMA). Following review of the data by the EMA’s Committee for Medicinal Products for Human Use (CHMP), the EC will consider converting the conditional marketing authorization to a full marketing authorization.
The EC decision was based on data from Study 200, a global, single-arm, open-label, multi-cohort, Phase 1/2 study of BOSULIF in more than 500 patients with Ph+ CML who had previously been treated with at least one TKI. The study included separate cohorts for patients with chronic, accelerated and blast phase disease. Data on 52 patients were considered as main evidence for the conditional marketing authorization, as these patients were identified as having an unmet medical need because other TKIs were not considered appropriate treatment options for them due to disease resistance or the risk of severe side effects.
“The approval of BOSULIF reflects the progress that is being made to address the unmet needs of CML patients in Europe and exemplifies Pfizer’s commitment to bringing meaningful new medicines to patients …read more
Source: FULL ARTICLE at DailyFinance
POZEN Submits New Drug Application for PA32540/PA8140
By Business Wirevia The Motley Fool
Filed under: Investing
POZEN Submits New Drug Application for PA32540/PA8140
CHAPEL HILL, N.C.–(BUSINESS WIRE)– POZEN Inc. (Nasdaq: POZN),a pharmaceutical company committed to transforming medicine that transforms lives, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of PA32540/PA8140. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. Pending regulatory approval, an indication is sought for the use of PA tablets for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced ulcers.
“The NDA submission for PA32540/PA8140 represents an important milestone for PA,” said John R. Plachetka, Pharm.D., Chairman, President and Chief Executive Officer of POZEN. “Although this PA NDA is focused on patients who need the beneficial lifesaving cardiovascular properties of aspirin but are at risk for developing gastric ulcers, it is our hope that sometime in the future additional research will confirm the promise of aspirin as an important drug in the war against cancer, and perhaps other diseases. In discussions with potential partners, we believe we have seen the same commitment from them to transform the benefit/risk profile of aspirin that has driven our team at POZEN over the past several years. We look forward to completing a commercial deal in the upcoming months with a partner that shares our passion for this product, our values, and is capable of making PA reach its fullest potential in the marketplace.”
The NDA submission is based on data from a comprehensive clinical trials program that POZEN conducted. This program included two pivotal Phase 3 studies (PA32540 – 301/PA32540 – 302) for PA32540, conducted under special protocol assessment (SPA) agreed with the FDA, which met their primary and secondary endpoints, as well as extensive Phase 1 studies for both PA32540 and PA8140. In the 301 and 302 studies, significantly fewer subjects taking PA32540 experienced endoscopically confirmed gastric ulcers compared to subjects receiving enteric-coated (EC) aspirin alone (Study 301: 3.8% vs. 8.7%, p=0.02; Study 302: 2.7% vs. 8.5%, p=0.005, respectively).
About Cardiovascular Disease
Patients with established coronary heart disease or cerebrovascular disease have a high risk of a subsequent cardiovascular event including myocardial infarction (MI), stroke and death from cardiovascular disease. For such patients, lifestyle changes and drug therapy are of proven benefit and will improve outcomes. Coronary artery disease is caused by atherosclerosis and often develops into angina pectoris and MI. The condition caused about 445,000 …read more
Source: FULL ARTICLE at DailyFinance
Hispalinux takes Microsoft to EC re UEFI Secure Boot
By finid From LinuxBSDos.com.
Hispalinux (in Spanish), a representative organization for Linux users in Spain, has lodged a complaint against Microsoft to the European Commission, the European Union’s…
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…read more
Source: FULL ARTICLE at LinuxBSDos
EC pressed to charge Google in antitrust case
Eleven complainants sent an open letter to European Union's Competition Commissioner JoaquAn Almunia urging him to formally charge Google with breaching competition law. …read more
Source: FULL ARTICLE at Computerworld Latest
Hazel Henderson: There is 21st Century Abundance Hiding in 19th Century Scarcity Politics
By Terry Waghorn, Contributor “We live in a world of abundance,” says Hazel Henderson, D.Sc.Hon., FRSA, president of Ethical Markets Media. As a futurist and evolutionary economist, Henderson used her insight to write Creating Alternative Futures: The End of Economics and Politics of the Solar Age. She is also author of the award-winning Ethical Markets: Growing the Green Economy. She leads the Transforming Finance initiative, created the Green Transition Scoreboard®, co-developed with Calvert the GDP alternative now renamed the Ethical Markets Quality of Life Indicators and co-organized the Beyond GDP conference for the European Commission. In preparation and subsequent to the EC conference, Ethical Markets has funded three Beyond GDP surveys, finding strong support worldwide for ESG metrics in national accounting. In 2012, she was named to the Post Growth Institute (En)Rich List as a top 100 luminary inspiring global prosperity beyond economic wealth and received the Award for Outstanding Contribution to Development of ESG & Investing at TBLI Europe. …read more
Source: FULL ARTICLE at Forbes Latest
POZEN Reports Fourth Quarter & Year End 2012 Results
By Business Wirevia The Motley Fool
Filed under: Investing
POZEN Reports Fourth Quarter & Year End 2012 Results
NDA Filing for PA32540/PA8140 Expected by Q2 2013
CHAPEL HILL, N.C.–(BUSINESS WIRE)– POZEN Inc. (Nasdaq: POZN),a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the fourth quarter and year ended December 31, 2012.
2012 and Recent Corporate Highlights
- POZEN is currently preparing a New Drug Application (NDA) for its investigational products containing enteric-coated (EC) aspirin and immediate release omeprazole, including two dosage forms, PA32540 containing 325 mg of aspirin and PA8140, a low dose formulation containing 81 mg aspirin. POZEN continues to anticipate filing the NDA for both products no later than Q2 2013.
- POZEN announced positive top-line results from two randomized, double-blind, multi-center, pivotal Phase 3 clinical trials of PA32540. Detailed results were presented in the fall at the American College of Gastroenterology (ACG) 2012 Annual Scientific Meeting and the American Heart Association (AHA) Scientific Sessions 2012.
- In August 2012, POZEN gained clarity from the Medicines Evaluation Board (MEB) in the Netherlands regarding the development program required for the approval in the European Union of PA including a lower dosage form containing 100 mg of aspirin and 40 mg of omeprazole (PA10040). The MEB agreed that no Phase 3 clinical trials for PA10040 to demonstrate the reduction of gastric ulcers vs. EC aspirin 100 mg would be necessary. MEB required 2 additional Phase 1 studies: a pharmacodynamic study demonstrating appropriate gastric pH control with PA10040 as well as a study to demonstrate bioequivalence of PA10040 to a currently marketed EC aspirin 100 mg product using aspirin as the analyte. The MEB also agreed to be the Reference Member State in a decentralized filing procedure for PA32540/PA10040.
- Partnership discussions for PA continue to progress. While there can be no assurances, the Company expects to close a partnership deal in 2013.
- Q4 2012 global net sales of VIMOVO® (naproxen / esomeprazole magnesium) delayed-release tablets by AstraZeneca, as defined under our agreement, were $18.4 million, up 33% from Q4 2011 and 38% vs. Q3 2012. VIMOVO sales for 2012 were $64.3 million, up 90% over the prior year, led by strong growth outside the U.S. POZEN earned a royalty of …read more
Source: FULL ARTICLE at DailyFinance
UPS to withdraw TNT Express bid after EC veto
United Parcel Service Inc (UPS) said it will withdraw its 5.2 billion euro ($7 billion) bid for TNT Express because it expects the European Commission (EC) to block the deal.