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News Breaks
March 14, 2012
06:55 EDTCRTX, CRTX, CRTX, ACOR, ACOR, ACOR, JNJ, JNJ, JNJ, DNA, DNA, DNA, LLY, LLY, LLY, MYL, MYL, MYL, IPXL, IPXL, IPXL, VRTX, VRTX, VRTX, NVS, NVS, NVS, AMLN, AMLN, AMLNInstitute for International Research to host a summit
4th Annual Government Programs Summit is being held in Baltimore on March 14-16.
News For AMLN;NVS;VRTX;IPXL;MYL;LLY;DNA;JNJ;ACOR;CRTX From The Last 14 Days
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December 12, 2014
05:31 EDTNVSNovartis reports Cosentyx 'superior' in head-to-head psoriasis study
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December 11, 2014
10:13 EDTLLYOn The Fly: Analyst Upgrade Summary
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08:40 EDTLLYEli Lilly upgraded at Morgan Stanley
As previously reported, Morgan Stanley upgraded Eli Lilly two notches to Overweight from Underweight. The firm has increased confidence in Eli Lilly's pipeline investments following recent external data in Alzheimer's and atherosclerosis and now expects potential evacetrapib peak sales of $3B and solanezumab peak sales of $10B. Price target raised to $85 from $60.
07:32 EDTMYLMylan launches generic version of Hikma Maple's Robaxin injection
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07:28 EDTVRTXCBI to hold a summit
2nd Specialty Data Optimization Summit is being held in Philadelphia on December 11.
07:06 EDTMYLMylan launches generic version of Orapred ODT
Mylan announced the U.S. launch of its Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg. This product is the first generic version of Shionogi's Orapred ODT. Mylan received final approval from the FDA for its Abbreviated New Drug Application for Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 15 mg, and 30 mg, and was awarded 180 days of generic drug marketing exclusivity. This product is indicated as an anti-inflammatory or immunosuppressive agent for certain conditions; and also for the treatment of certain endocrine conditions, and for palliation of certain neoplastic conditions. Prednisolone Sodium Phosphate Orally Disintegrating Tablets had U.S. sales of approximately $19.9M for the 12 months ending September 30.
06:22 EDTLLYEli Lilly upgraded to Overweight from Underweight at Morgan Stanley
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December 10, 2014
07:38 EDTMYLMylan launches generic version of Pfizer's Celebrex capsules
Mylan (MYL) announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's (PFE) Celebrex Capsules, indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Celecoxib Capsules had U.S. sales of approximately $2.5B for the 12 months ending September 30, 2014.
07:02 EDTACORAcorda Therapeutics announces initiation of Phase 3 CVT-301 trial
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December 9, 2014
07:44 EDTLLY, DNAAmerican Association for Cancer Research to hold a symposium
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07:11 EDTLLYEli Lilly and Incyte announce Phase 3 RA-BEACON study met primary endpoint
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05:50 EDTJNJPharmacyclics data demonstrates safety, durability response
New, 27-month IMBRUVICA median follow-up data announced by Pharmacyclics (PCYC) support the use of IMBRUVICA over longer periods of time in patients with relapsed/refractory mantle cell lymphoma, or MCL, an aggressive type of lymphoma. More than 30% of IMBRUVICA patients remained progression-free after two years with no new or unexpected adverse events occurring during that time. Nearly half of the 111 patients treated were still living at the time of the data analysis. A second Phase II trial looked at IMBRUVICA's efficacy and safety as a single-agent treatment for MCL patients who previously had received rituximab combination therapy and at least two cycles of bortezomib. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:43 EDTJNJPharmacyclics reports IMBRUVICA data shows 84% PFS rate at one year
Pharmacyclics (PCYC) announced new, longer term data in IMBRUVICA patients with relapsed/refractory chronic lymphocytic leukemia, or CLL, including high-risk CLL patients with deletion 17p. Results from the Phase III RESONATE trial demonstrated an 84% progression-free survival, or PFS, rate in all patients with previously treated CLL or small lymphocytic lymphoma, or SLL, who received IMBRUVICA and a 94% PFS rate in patients who received only one prior therapy at 12 months. Separately, follow-up data was reported from Phase II RESONATE-17, or PCYC-1117, the largest prospective trial dedicated to studying CLL or SLL patients with del 17p. The data showed that IMBRUVICA was associated with an 83% overall response rate, or ORR, at a median follow up of 11.5 months. At 12 months, the estimated PFS was 79%. These results and additional data were presented here at the 56th American Society of Hematology, or ASH, Annual Meeting, highlighting IMBRUVICA's sustained efficacy in relapsed/refractory patients who have received at least one prior therapy. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:27 EDTJNJPharmacyclics IMBRUVICA Phase II combination data shows positive profile
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December 8, 2014
13:07 EDTNVSNovartis announces data from Jakavi trial
Novartis (NVS) announced data from the largest clinical trial of myelofibrosis patients treated with Jakavi, supporting the safety profile and efficacy benefit as measured in primary and secondary endpoints respectively. In an analysis of 1,144 patients treated with Jakavi to date in this ongoing expanded access study, 69% of patients achieved >50% reduction in spleen size from baseline and patients also experienced a clinically meaningful improvement in myelofibrosis symptom score, important treatment goals for patients with myelofibrosis. Findings from the study were presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, California. Novartis research and development efforts, in collaboration with Incyte Corporation (INCY), include early-phase and post-marketing studies in myelofibrosis and other myeloproliferative neoplasms. More than 50 abstracts on ruxolitinib are being presented at ASH, including three oral presentations exploring combinations of ruxolitinib with various investigational compounds, evaluating the possibility of simultaneously targeting multiple cancer pathways that may be involved in the pathogenesis of myelofibrosis. The JUMP study is a Phase IIIb, expanded-access trial for countries with no access to Jakavi outside of a clinical trial. The open-label, multicenter study analyzed 1,144 enrolled myelofibrosis patients who received daily starting doses of either 5 mg, 15 mg or 20 mg of Jakavi twice daily based on platelet counts at baseline. The primary endpoint is assessment of safety and tolerability of Jakavi. Overall, the safety and efficacy profile of Jakavi was consistent with previous studies.
13:05 EDTNVSNovartis reports six-year results from Phase III ENESTnd study
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11:30 EDTIPXL, MYL, NVSLeerink generics pharmaceutical analyst holds analyst/industry conference call
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08:10 EDTLLYLilly, Anthem, HealthCore form five-year research collaboration
Eli Lilly and Company (LLY), Anthem (ANTM) and HealthCore, Inc. announced that they have formed a five-year, real-world evidence research collaboration intended to improve health outcomes for patients. The companies will jointly develop and conduct research projects in health outcomes and real-world evidence in areas of mutual interest. Each party will bring distinct and valuable contributions to the collaboration, including the U.S. provider and patient environment, research capabilities, therapeutics and methods expertise, and integrated, researchable data. The collaboration allows the organizations to explore research opportunities across disease states and incorporate surveys and other information from providers and patients.
07:29 EDTIPXLUBS to hold investor trip
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05:42 EDTNVSSandoz Phase III data shows filgrastim has similar safety, efficacy as NEUPOGEN
Sandoz, a Novartis (NVS) company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's (AMGN) NEUPOGEN in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity. The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
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