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News Breaks
June 26, 2013
11:15 EDTJNJ, PFE, ABT, MDT, BSXJ&J, Pfizer lose bid to revive heart device patent claims
The claims were against Abbott (ABT), Medtronic (MDT) and Boston Scientific (BSX).
News For JNJ;PFE;ABT;MDT;BSX 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.
08:01 EDTPFEPfizer announces FDA acceptance of Palbociclib NDA with priority review
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07:25 EDTJNJEuropean 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 EDTMDT, JNJBioFlorida to hold a conference
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October 10, 2014
10:01 EDTJNJOn The Fly: Analyst Upgrade Summary
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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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08:06 EDTPFEPfizer presents Staphylococcus aureus vaccine Phase 1, Phase 2 study data
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07:07 EDTJNJJohnson & Johnson upgraded to Neutral from Underperform at Credit Suisse
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07:04 EDTMDTMedtronic 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 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.
10:55 EDTPFELeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
08:09 EDTPFEPfizer presents LP2086 Phase 2 study data
Pfizer announced it will present the results of a Phase 2, randomized study to evaluate co-administration of the company’s investigational meningococcal group B vaccine, bivalent recombinant LP2086, or rLP2086, with a licensed quadrivalent human papillomavirus vaccine at IDWeek 2014. Data demonstrated immune responses to both vaccines were generated after concomitant administration of bivalent rLP2086 and HPV4. Prespecified noninferiority criteria were met for the bivalent rLP2086 antigens studied and three of the four antigens for HPV4. Primary immunogenicity endpoints, measured after the third dose, included geometric mean titers against HPV antigens in Groups 1 and 3 and human complement serum bactericidal assay GMTs against meningococcal group B disease test strains in Groups 1 and 2. Secondary immunogenicity endpoints included the rate of seroconversion to HPV antigens. Safety of bivalent rLP2086 was assessed after concomitant administration with HPV4 or saline. The prespecified noninferiority criteria were met for three of four HPV antigens and both meningococcal group B disease test strains. Seroconversion for all four HPV antigens was achieved by 99% or more of the subjects for the groups that received HPV4 concomitantly with bivalent rLP2086 or with saline. More local reactions occurred following administration of bivalent rLP2086 compared with saline but the incidence of these reactions did not increase with subsequent vaccine administration. The rates of local and systemic reactions were comparable when bivalent rLP2086 was given with HPV4 to bivalent rLP2086 given alone.
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
07:19 EDTPFECBI to hold a conference
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07:18 EDTPFEInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
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