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News Breaks
June 1, 2014
15:54 EDTGSK, PCYC, JNJPharmacyclics announces trial results of Imbruvica vs. ofatumumab
Pharmacyclics (PCYC) announced trial results of the first Phase III study, RESONATE, PCYC-1112-CA, a head-to-head comparison of IMBRUVICA, ibrutinib, versus ofatumumab in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma, CLL/SLL. Patients receiving IMBRUVICA realized a significant improvement in progression free survival, PFS, overall survival, OS, and overall response rate, ORR, as compared to patients receiving ofatumumab (GSK). The RESONATE data will be discussed in the official Press Program by lead investigator Dr. John Byrd from The Ohio State University Medical Center at the American Society of Clinical Oncology, ASCO, Annual Meeting in Chicago. This release corresponds to abstract LBA7008. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech (JNJ).
News For PCYC;GSK;JNJ From The Last 14 Days
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November 19, 2014
09:04 EDTJNJJohnson & Johnson submits NDA for three-month paliperidone palmitate
Janssen Research & Development, a Johnson & Johnson company, announced the submission of a New Drug Application, or NDA, for three-month atypical antipsychotic paliperidone palmitate to the FDA. The NDA seeks approval for the medication as a treatment for schizophrenia in adults. If approved, it will be the first and only long-acting atypical antipsychotic that has a four times a year dosing schedule.
07:52 EDTGSKInforma Business Information to hold a conference
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06:30 EDTJNJJohnson & Johnson, Boston Scientific trial set to start tomorrow, Reuters says
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November 18, 2014
07:20 EDTGSKEuro Organization for Research & Treatment of Cancer co-hosts a symposium
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November 17, 2014
17:02 EDTGSKClovis in oncology clinical trial collaboration with GlaxoSmithKline
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07:16 EDTJNJMilken Institute--Faster Cures to hold a conference
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05:32 EDTGSKMedidata announces collaboration with GlaxoSmithKline
Medidata (MDSO) announced the completion of a method development project conducted in partnership with GlaxoSmithKline (GSK) to evaluate the impact of unifying mobile health, or mHealth, devices with cloud-based technologies in a clinical trial setting. The joint initiative assessed the capabilities of mHealth tools and evaluated how they could be used to enable a new model for clinical trial conduct that aligns site and patient needs with faster study execution and reduced costs. The collaborative project, which took place at GSK’s Human Performance Lab, demonstrated that mHealth technologies have the power to comprehensively collect large volumes of objective data that is reliable, secure and analysis-ready, and provides real-time, continuous insight into the well being of patients. All of the data collected was audited and is compliant with FDA regulations. Additionally, the effort indicated that mobile devices can support the long-term goal of lessening the burden on patients participating in studies by streamlining routine procedures, eliminating unnecessary ones and reducing visits to clinical trial sites.
November 14, 2014
16:21 EDTJNJOn The Fly: Closing Wrap
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14:53 EDTJNJ, GSKCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
07:14 EDTGSKAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
November 13, 2014
16:28 EDTJNJGeron announces global strategic collaboration with Janssen Biotech
Geron (GERN) announced that the company has entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, a Johnson & Johnson (JNJ) company, to develop and commercialize, imetelstat, Geron's telomerase inhibitor product candidate, for oncology, including hematologic malignancies, and other human therapeutics uses. Imetelstat is a modified oligonucleotide that is currently in early phase clinical development for myelofibrosis, or MF, and may have activity in other hematologic myeloid malignancies such as myelodysplastic syndrome, or MDS, and acute myelogenous leukemia, or AML. Under the terms of the agreement, Geron will receive an initial payment of $35M due after the applicable waiting periods under the Hart-Scott Rodino Act and is eligible to receive additional payments up to a potential total of $900M for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. Certain regulatory, development, manufacturing and promotional activities will be managed through a joint governance structure, with Janssen responsible for operational implementation of these activities. All sales will be booked by Janssen.
12:59 EDTGSKApollo plans bid for GSK mature drugs business, Reuters reports
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11:54 EDTJNJJanssen announces FDA approved sNDA for INVEGA SUSTENNA
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10:44 EDTJNJMallinckrodt news on generic Concerta positive for Actavis, says BMO Capital
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November 12, 2014
09:16 EDTGSKLigand reports GlaxoSmithKline EU regulatory submission for Revolade
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08:53 EDTGSKGlaxoSmithKline weakness creates buying opportunity, says Argus
After GlaxoSmithKline cut its near-term EPS guidance, Argus still believes that the company's deals with Novartis (NVS) should boost its EPS growth in the years ahead, likely as soon as 2015. The firm thinks the stock is a good value for long-term investors, and it keeps a Buy rating on the shares.
08:18 EDTGSKUBS to hold a conference
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07:53 EDTPCYCLeerink to hold a tour
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November 10, 2014
16:07 EDTGSKUBS to hold a conference
UBS European Conference is being held in London, England on November 11-12.
07:44 EDTJNJJohnson & Johnson looks for acquisitions to help expand in China, WSJ says
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