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May 30, 2014
04:55 EDTAZN, AZN, AZN, AZN, AZN, NVS, NVS, NVS, NVS, NVS, THLD, THLD, THLD, THLD, THLD, ABBV, ABBV, ABBV, ABBV, ABBV, RHHBY, RHHBY, RHHBY, RHHBY, RHHBY, JNJ, JNJ, JNJ, JNJ, JNJ, CLSN, CLSN, CLSN, CLSN, CLSN, PFE, PFE, PFE, PFE, PFE, NBS, NBS, NBS, NBS, NBS, INO, INO, INO, INO, INO, CLVS, CLVS, CLVS, CLVS, CLVS, BAYRY, BAYRY, BAYRY, BAYRY, BAYRY, BMY, BMY, BMY, BMY, BMY, MACK, MACK, MACK, MACK, MACKAmerican Society of Clinical Oncology to hold annual meeting
50th Annual Meeting of ASCO is being held in Chicago on May 30-June 3.
News For AZN;BMY;BAYRY;CLVS;INO;NBS;PFE;CLSN;JNJ;RHHBY;ABBV;THLD;NVS;MACK From The Last 14 Days
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December 9, 2014
08:25 EDTBMYBristol-Myers data positive, says BMO Capital
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08:02 EDTAZNMoventig approved in EU for opioid-induced constipation
Nektar (NKTR) reported partner AstraZeneca (AZN) announced that MOVENTIG has been granted Marketing Authorisation by the European Commission for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxative. MOVENTIG is the first once-daily oral peripherally-acting mu-opioid receptor antagonist to be approved in the European Union.
07:44 EDTPFE, AZN, RHHBY, ABBVAmerican Association for Cancer Research to hold a symposium
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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).
05:38 EDTBAYRYBayer downgraded to Neutral from Buy at BofA/Merrill
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05:27 EDTJNJPharmacyclics IMBRUVICA Phase II combination data shows positive profile
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December 8, 2014
13:32 EDTBMY, PFEPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
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 EDTNVSLeerink generics pharmaceutical analyst holds analyst/industry conference call
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08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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07:35 EDTNBSNeoStem earns AABB re-accreditation for NJ manufacturing facility
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07:05 EDTAZNInnocoll appoints Tony Zook as CEO
Innocoll AG (INNL) announced that Tony Zook, formerly executive vice president, Global Commercial Operations, at AstraZeneca (AZN), has been appointed CEO effectively immediately. Michael Myers, will continue with the company as head of Portfolio Operations.
05:53 EDTBMYStocks with implied volatility movement; BSX BMY
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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.
December 7, 2014
16:48 EDTTHLDThreshold Pharmaceuticals announces data from TH-302 study
Threshold Pharmaceuticals announced new preliminary data from the Phase 2 component of an ongoing company-sponsored Phase 1/2 trial of TH-302, the company's lead investigational anticancer drug, in combination with the proteasome inhibitor bortezomib, Velcade, and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma. The median number of prior therapies was 8. The recommended phase 2 dose of TH-302 was determined to be 340 mg/m2 and no dose limiting toxicities were observed at this dose level. Partial responses were observed in 2 of 7 evaluable patients overall and 2 of 4 evaluable patients at the recommended phase 2 dose of TH-302. These data are being presented today at the 56th ASH Annual Meeting and Exposition in San Francisco, California.
14:54 EDTJNJIMBRUVICA data suggests promise in multiple myeloma
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14:10 EDTTHLD, BMYAmerican Society of Hematology to hold a meeting
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13:06 EDTBMYBMY announces positive results in Phase 1b trial evaluating Opdivo
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