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News Breaks
January 3, 2014
17:52 EDTCAPR, JNJCapricor gets $12.5M upfront payment in Janssen development agreement
Capricor Therapeutics (CAPR) disclosed in a regulatory filing that it entered into a collaboration agreement and with Janssen Biotech, a wholly-owned subsidiary of Johnson & Johnson (JNJ). Under the terms of the agreement, Capricor and Janssen agreed to collaborate on the development of Capricor’s cell therapy program for cardiovascular applications, including its lead product, CAP-1002. Capricor and Janssen further agreed to collaborate on the development of cell manufacturing in preparation for future clinical trials. Under the agreement, Capricor will receive an upfront cash payment of $12.5M from Janssen, and Capricor will also contribute to the costs of development of a chemistry, manufacturing and controls package. In addition, Janssen will have the exclusive right to enter into an exclusive license agreement pursuant to which Janssen would receive a worldwide, exclusive license to exploit CAP-1002 as well as certain allogeneic cardiospheres and cardiosphere-derived cells in the field of cardiology. Janssen has the right to exercise the option at any time until sixty days after the delivery by Capricor of the six-month follow-up results from Phase II of Capricor’s ALLSTAR clinical trial for CAP-1002. If Janssen exercises its option rights, Capricor would receive an upfront license fee and additional milestone payments which may total up to $325M. In addition, a double-digit royalty would be paid on commercial sales of licensed products
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October 14, 2014
08:17 EDTCAPRCapricor Therapeutics to acquire certain patent rights from Medtronic
Capricor Therapeutics (CAPR) announced that it has entered into an agreement to acquire patent rights from Medtronic (MDT) relating to the formulation and pump delivery of natriuretic peptides. Capricor recently announced that it plans to develop a clinical program using Cenderitide, a natriuretic peptide, for the treatment of post-acute heart failure.
07:50 EDTJNJJohnson & Johnson: Alios BioPharma transaction expected to close in Q4 of 2014
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07:50 EDTJNJJohnson & Johnson reports Q3 Worldwide Consumer sales down 0.6% to $3.6B
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07:49 EDTJNJJohnson & Johnson raises FY14 EPS to $5.92-$5.97 from $5.85-$5.92
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07:48 EDTJNJJohnson & Johnson reports Q3 domestic sales up 11.6% to $8.84B
Reports Q3 international sales down 0.3% to $9.63B. Worldwide, domestic and international operational sales growth, excluding the impact of this divestiture, was 8.4%; 14.8% and 3.1% respectively.
07:46 EDTJNJJohnson & Johnson reports Q3 adjusted EPS $1.50, consensus $1.44
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October 13, 2014
15:24 EDTJNJNotable companies reporting before tomorrow's open
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14:24 EDTJNJJohnson & Johnson October volatility increases into Q3 and outlook
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14:15 EDTJNJEarnings Preview: Johnson & Johnson looks to new drugs to boost Q3 sales
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14:08 EDTJNJJohnson & Johnson technical notes before earnings
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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.
07:25 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 EDTJNJBioFlorida 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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07:07 EDTJNJJohnson & Johnson upgraded to Neutral from Underperform at Credit Suisse
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06:27 EDTJNJJohnson & Johnson upgraded to Neutral from Underperform at Credit Suisse
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