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News Breaks
February 9, 2013
14:51 EDTARRY, NVS, AZNArray expects to make progress on generating data on hematology programs
In a press release Array BioPharma said : During 2013, Array (ARRY) expects to make substantial progress in generating data to inform registration study decisions for our wholly-owned hematology programs, ARRY-520 and ARRY-614. Array-invented MEK162 will be tested in a Phase 3 trial in NRAS melanoma which is scheduled to start in April 2013, as well as BRAF mutant melanoma later in 2013 (with Novartis (NVS)). Also, AstraZeneca (AZN) recently announced a potential start of a Phase 3 trial with Array-invented selumetinib in non-small cell lung cancer during the second half of 2013.
News For ARRY;NVS;AZN From The Last 14 Days
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October 22, 2014
07:35 EDTAZNCardiometabolic Health Congress to hold annual meeting
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October 21, 2014
07:15 EDTNVS, AZNFDA to hold workshop on breast cancer drug development
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06:10 EDTAZNInovio, MedImmune, UPENN awarded $12.2M collaborative study by DARPA
Inovio Pharmaceuticals (INO) announced the Defense Advanced Research Projects Agency, or DARPA, has awarded $12.2M for a collaborative study that will be conducted by scientists from the Perelman School of Medicine at the University of Pennsylvania; Inovio Pharmaceuticals; and MedImmune, the global biologics research and development arm of AstraZeneca (AZN). The group will develop DNA-based monoclonal antibodies, or mAbs, for infectious disease treatment. DARPA is an agency of the US Department of Defense that creates and supports novel technologies important for national security. Together, the three organizations will develop and assess the DNA mAbs in preclinical studies using technology developed by Penn and licensed by Inovio. The collaboration will focus on three disease areas influenza virus, Pseudomonas aeruginosa and Staphylococcus aureus.
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.
07:47 EDTAZNPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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07:19 EDTAZNIBC Life Sciences to hold a conference
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07:14 EDTAZNEuropean College of Neuropsychopharmacology to hold a conference
27th ECNP Congress is being held in Berlin, Germany on October 18-21.
October 17, 2014
14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
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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%.
10:48 EDTAZNShire tanks with AbbVie calling board meeting over merger
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October 14, 2014
11:23 EDTAZN, 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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07:53 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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05:27 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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October 10, 2014
08:53 EDTARRYArray drug has little evidence of being effective, says Summer Street
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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.
October 9, 2014
09:20 EDTARRYSummer Street chief scientific officer holds an analyst/industry conference call
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08:10 EDTAZNAstraZeneca reports Phase IIb study of benralizumab met primary endpoint
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