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News Breaks
January 28, 2014
09:08 EDTJNJCordis announces 'positive' two-year data from INCRAFT trial
Cordis, a unit of Johnson & Johnson, announced the presentation of two-year data from its INNOVATION Trial. Data from the study continues to demonstrate that the INCRAFT System performs well in patients suffering from abdominal aortic aneurysms two years after treatment. The company said, "These positive results are encouraging and build on the favorable short and mid-term outcomes of the INCRAFT System observed in the recently published one-year results of the INNOVATION Trial. Cordis’ INCRAFT System has the potential to be a valuable alternative to current devices on the market. The system is designed to offer increased applicability in the broad spectrum of anatomical sizes encountered in patients undergoing endovascular aneurysm repair.” The INCRAFT System is approved for investigational device use only and it not for sale anywhere in the world. The device is currently being investigated in a global pivotal clinical study in the U.S. and Japan called the INSPIRATION Trial, which completed enrollment in August 2013. One-year follow-up data from the trial will support a Premarket Approval application to the U.S. Food and Drug Administration and a Shonin application in Japan.
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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.
06:30 EDTJNJJohnson & Johnson, Boston Scientific trial set to start tomorrow, Reuters says
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November 17, 2014
07:16 EDTJNJMilken Institute--Faster Cures to hold a conference
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November 14, 2014
16:21 EDTJNJOn The Fly: Closing Wrap
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14:53 EDTJNJCVS 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),
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.
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 10, 2014
07:44 EDTJNJJohnson & Johnson looks for acquisitions to help expand in China, WSJ says
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November 7, 2014
16:07 EDTJNJJohnson & Johnson completes acquisition of Alios BioPharma
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November 6, 2014
15:41 EDTJNJRulings encouraging for Boston Scientific in suit with J&J, says Wells Fargo
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