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January 7, 2013
09:55 EDTINFI, INFI, SFE, SFE, CELG, CELG, IMGN, IMGN, NVS, NVS, QSII, QSII, THOR, THORJPMorgan to host a conference
31st Annual Global Healthcare Conference is being held in San Francisco on January 7-10 with webcasted company presentations to begin on January 7 at 10 am; not all company presentations may be webcasted. Webcast Link
News For INFI;SFE;CELG;IMGN;NVS;QSII;THOR From The Last 14 Days
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October 20, 2014
15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
13:26 EDTCELGCelgene I&I franchise boosted by Crohn’s trial data, says William Blair
William Blair said it views the preliminary Phase II efficacy and safety data from mongersen in Crohn’s disease reported by Celgene as encouraging. The firm noted that the 10 mg arm did not achieve significance, but the three data points collectively formed a robust dose-response that William Blair said lends support for the drug's proposed mechanism of action. William Blair believes mongersen complements Celgene’s Inflammation & Immunology portfolio and the firm maintains its Outperform rating on the stock, which is up 4% to $91.65 in afternoon trading.
13:21 EDTCELGCelgene reports Phase II data in Crohn’s Disease to be presented at UEG
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07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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07:19 EDTIMGNIBC Life Sciences to hold a conference
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07:04 EDTINFIInfinity Pharmaceuticals coverage resumed with a Hold at Stifel
October 17, 2014
14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
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13:18 EDTCELGLeerink's biotech analyst holds an analyst/industry conference call
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10:16 EDTTHORHigh option volume stocks
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05:20 EDTQSII NextGen Healthcare, InterSystems demonstrate cross-vendor interoperability
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October 16, 2014
15:10 EDTCELGAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.
07:41 EDTINFIInfinity reports duvelisib Phase 2a primary endpoint not met
Infinity Pharmaceuticals announced encouraging topline data from its Phase 2a exploratory study of duvelisib, or IPI-145. Data from this randomized, double-blind, placebo-controlled, cross-over study demonstrated that duvelisib was well tolerated and met several secondary and exploratory endpoints in an allergen challenge study. Clinical improvement was observed in the late-phase asthmatic response FEV1 among patients who received duvelisib administered at the highest dose tested, 25 mg twice daily for five days, however the primary endpoint of the study was not met as it did not reach statistical significance. Multiple secondary clinical endpoints measuring improvements in lung function following duvelisib administration were achieved with statistical significance and were associated with changes in key cytokines and chemokines involved in the asthmatic response. Taken together, these data demonstrate early proof-of-activity in this allergen challenge study. Infinity expects to present the final data in a peer-reviewed setting after all analyses are complete. In addition, the company anticipates determining its next steps for development of PI3K-delta,gamma inhibitors in inflammation after evaluating the results from the ASPIRA study in rheumatoid arthritis, which are expected by the end of 2014.
October 15, 2014
17:03 EDTNVSNovartis announces CTL019 data demonstrating efficacy in certain ALL patients
Novartis and the University of Pennsylvania's Perelman School of Medicine announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine, or NEJM, evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia, or r/r ALL. The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor, or CAR, therapy CTL019. Largest published cohort to date for CTL019, which served as the basis for recent Breakthrough Therapy designation from the FDA. Sustained remissions of up to two years in r/r ALL patients with six-month event-free survival of 67% and overall survival of 78%.
October 14, 2014
11:23 EDTNVSBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
13:05 EDTINFIInfinity Pharmaceuticals management to meet with ISI Group
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11:50 EDTSFESafeguard Scientifics to host investor day with a conference call hookup
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07:25 EDTTHOREuropean Association of Cardiothoracic Surgery to hold annual meeting
28th EACTS Annual Meeting is being held in Milan, Italy on October 11-15.
October 10, 2014
08:41 EDTCELGCelgene reports apremilast significantly improved preexisting psoriasis in study
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08:39 EDTCELGCelgene says data show Apremilast treatment resulted in improved quality of life
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05:13 EDTNVSNovartis reports new analyses of AIN457 Phase III data show consistent efficacy
Novartis announced that new analyses of AIN457 Phase III studies showed that treatment with secukinumab 300 mg resulted in higher rates of clear to almost clear skin at Week 12 versus placebo, regardless of patients' psoriasis disease severity. Secukinumab's new mode of action stops interleukin-17A, which plays a central role in the development of psoriasis. In the analyses, the majority of patients across two disease severity subgroups, including those with severe psoriasis, experienced complete clear to almost clear skin measured as 100 or 90% reduction of respective baseline PASI, or Psoriasis Area and Severity Index. Skin clearance was sustained through one year of treatment. This is important as historically, psoriasis patients' disease severity at the start of treatment has been shown to negatively impact their response to other therapies. Disease severity subgroups were PASI less than or equal to 20 and PASI greater than 20. PASI measures redness, scaling and thickness of psoriatic plaques and the impact in regions of the body. These findings reconfirm the significantly better responses seen in the published FIXTURE study, where secukinumab showed superiority to Enbrel, a standard of care anti-TNF medication.
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