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News Breaks
March 19, 2014
07:28 EDTCELG, NVGN, ARGS, ADXS, CAH, NAVB, AZN, PFE, RHHBY, NVS, RNN, ACTMSachs Associates to hold a forum
2nd Annual Sachs Cancer Bio Partnering & Investment Forum is being held in New York on March 19.
News For CELG;RNN;NVS;RHHBY;PFE;AZN;NAVB;CAH;ADXS;ARGS;NVGN;ACTM From The Last 14 Days
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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%.
15:45 EDTRHHBYFDA approves Esbriet to treat idiopathic pulmonary fibrosis
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15:00 EDTPFEShire-Allergan, AbbVie-Pfizer deals possible if merger scrapped, Bloomberg says
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10:48 EDTAZNShire tanks with AbbVie calling board meeting over merger
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09:20 EDTNAVBOn The Fly: Pre-market Movers
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08:03 EDTNAVBNavidea names Gonzalez CEO
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08:01 EDTNAVBNavidea names Gonzalez CEO
07:36 EDTADXSAdvaxis provides clinical update for Phase 1/2 trial of ADXS-HPV candidate
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07:03 EDTNAVBNavidea announces FDA sNDA approval for Lymphoseek extended use
Navidea Biopharmaceuticals announced that the U.S. Food and Drug Administration has approved the Supplemental New Drug Application for the expanded use of Lymphoseek injection for lymphatic mapping in solid tumors and adding Sentinel Lymph Node detection for breast cancer and melanoma to the approved indications. The FDA also allowed expanded utilization of Lymphoseek with or without scintigraphic imaging to enable pre-operative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures. Lymphoseek will be immediately available using existing reimbursement codes for this expanded population of cancer patients. In the approval action letter, the FDA also outlined a post-marketing requirement for initiation of a pediatric study in solid tumor cancer with a target date for submission in 2018.
October 14, 2014
11:23 EDTPFE, RHHBY, AZN, NVSBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
10:08 EDTAZNOn The Fly: Analyst Upgrade Summary
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09:21 EDTAZNOn The Fly: Pre-market Movers
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08:01 EDTPFEPfizer announces FDA acceptance of Palbociclib NDA with priority review
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07:53 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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07:37 EDTCAHAmerican Society of Anesthesiologists to hold annual meeting
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05:27 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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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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08:06 EDTPFEPfizer presents Staphylococcus aureus vaccine Phase 1, Phase 2 study data
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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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