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May 14, 2014
08:15 EDTMDT, BSX, JNJ, ZMH, COV, BCRRepeal of medical device tax pushed by Republicans, Bloomberg says
Republicans are trying to include the repeal of a medical device excise tax that has been opposed by companies such as Medtronic (MDT) and Boston Scientific (BSX) in a package of tax breaks moving through the Senate, reported Bloomberg. Other publicly traded medical device makers include Johnson & Johnson (JNJ), Zimmer (ZMH), Covidien (COV), and C.R. Bard (BCR). Reference Link
News For MDT;BSX;JNJ;ZMH;COV;BCR From The Last 14 Days
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October 13, 2014
08:40 EDTJNJAlios BioPharma reports positive results for AL-8176 in Phase 2 study
Alios BioPharma presented results from a randomized, double-blind, placebo-controlled Phase 2 challenge study of its oral anti-RSV nucleoside analog AL-8176 this past weekend at the IDWeek 2014 Conference in Philadelphia, PA. The study was conducted in healthy adult volunteers who were infected intranasally with respiratory syncytial virus, or RSV. AL-8176 achieved its primary and secondary endpoints of reduction in viral load and improvement in symptom scores as compared to placebo. AL-8176 was well tolerated with no discontinuations of study drug and no clinically significant laboratory abnormalities. In successfully infected subjects, a rapid and marked reduction in RSV viral load was observed following treatment in all three AL-8176 treated dose groups as compared to placebo. In contrast, successfully infected placebo subjects exhibited a logarithmic increase in RSV RNA with a peak viral load at Day 3.5 following start of dosing with placebo. The mean time to non-detectability of RSV RNA was 1.3-2.3 days for the AL-8176 treatment groups compared to 7.2 days in the placebo group. At discharge, all subjects treated with AL-8176 were RSV RNA undetectable and remained RSV RNA undetectable upon follow-up on Days 16 and 28. The viral load reduction in infected subjects across all AL-8176 dosing regimens was associated with concomitant improvements in RSV symptom scores and reductions in mucus weight. On September 30, Johnson & Johnson announced a definitive agreement to acquire Alios.
08:05 EDTJNJBristol-Myers, Pharmacyclics, Janssen announce clinical collaboration
Bristol-Myers Squibb Company (BMY), Pharmacyclics, Inc. (PCYC), and Janssen Research & Development, LLC (JNJ) announced today they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO in combination with IMBRUVICA, an oral Bruton's tyrosine kinase inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia. Bristol-Myers Squibb has proposed the name OPDIVO, which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab. OPDIVO is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies. The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.
07:37 EDTCOVAmerican Society of Anesthesiologists to hold annual meeting
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07:25 EDTJNJ, COVEuropean Association of Cardiothoracic Surgery to hold annual meeting
28th EACTS Annual Meeting is being held in Milan, Italy on October 11-15.
07:15 EDTJNJNational Association of Corporate Directors to hold a conference
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07:13 EDTJNJ, MDTBioFlorida to hold a conference
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October 10, 2014
10:01 EDTJNJOn The Fly: Analyst Upgrade Summary
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09:29 EDTBCRC.R. Bard announces FDA approval of Lutonix
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08:19 EDTJNJMedivir announces Janssen initiates enrolment in phase II IMPACT study
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08:15 EDTJNJJohnson & Johnson reports additional data from ATTAIN study
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07:16 EDTCOVAmerican Society of Plastic Surgeons to hold annual meeting
Annual Meeting of ASPS is being held in Chicago on October 10-14.
07:07 EDTJNJJohnson & Johnson upgraded to Neutral from Underperform at Credit Suisse
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07:04 EDTMDT, COVMedtronic announces Omar Ishrak will remain CEO of new company
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06:27 EDTJNJJohnson & Johnson upgraded to Neutral from Underperform at Credit Suisse
October 9, 2014
16:37 EDTCOVCovidien receives FDA 510k clearance for Nellcor Portable SpO2 system
Covidien announced FDA 510k clearance for the Nellcor Portable SpO2 Patient Monitoring System. The system is the only commercially available portable oximeter that is equipped with home care and sleep study modes and complies with IEC 60601-1-11 standards for devices used in the home health care environment.
06:18 EDTZMHBiomet reports Q1 sales up 6% to $775M
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October 8, 2014
20:03 EDTBSXBoston Scientific confirms FDA panel votes for WATCHMAN device
After reviewing updated data and analysis for the Boston Scientific Corporation WATCHMAN Left Atrial Appendage Closure Device, the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee voted in favor of the Device. By a vote of 6 to 5, with 1 abstention, the panel concluded that the benefits of the WATCHMAN Device outweigh the potential risks. The panel voted that there is reasonable assurance that the device is safe, with a 12 yes to 0 no vote. On the question of reasonable assurance of effectiveness, the panel vote was unfavorable with a 6 yes to 7 no vote. The panel provided substantial input and guidance related to the proposed Indications for use and target patient population. There was widespread agreement among the panel members that the device provides a much needed alternative to long-term anticoagulation for some patients. While not bound by this vote, the FDA takes Advisory Panel comments and recommendations into account when reviewing the WATCHMAN Device application. The company is committed to working with the FDA to address the panel's comments.
18:42 EDTBSXBoston Scientific Watchman Device receives votes from FDA panel, Dow Jones says
The FDA Panel voted 6 to 5 that benefits of Boston Scientific's Watchman device outweigh the risks, Dow Jones reports. The panel voted 12 to 0 that the Watchman device is safe, and the panel voted 7 to 6 that the Watchman device is not effective, Dow Jones added.
10:46 EDTCOVOptions with decreasing implied volatility
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07:24 EDTBSXFDA Circulatory Systems Devices Panel to hold a meeting
The Committee discusses, makes recommendations and votes on information related to the Pre-Market Approval Application regarding Boston Scientific’s WATCHMAN Left Atrial Appendage (LAA) Closure Technology in a meeting being held in Gaithersburg, Maryland on October 8 at 8 am. Webcast Link
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