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December 11, 2012
07:54 EDTTEVA, NPSP, CELG, AZN, ACOR, PFE, ALKS, PRXL, MEDIElsevier Business Intelligence to host a summit
The FDA/CMS Summit for Biopharma Executives: Life After 2012 is being held in Washington, D.C. on December 10-11.
News For MEDI;PFE;CELG;PRXL;ACOR;NPSP;ALKS;AZN;TEVA From The Last 14 Days
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December 9, 2014
07:44 EDTPFE, CELG, AZN, TEVAAmerican Association for Cancer Research to hold a symposium
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05:46 EDTCELGCelgene presents POMALYST/IMNOVID Phase IIIb study results at ASH meeting
Celgene announced that results from the STRATUS trial, a single-arm phase IIIb study of pomalidomide plus low-dose dexamethasone in patients with relapsed and refractory multiple myeloma were presented at the 56th American Society of Hematology annual meeting. Pomalidomide is marketed as POMALYST in the United States and IMNOVID in the European Union. In the study, 599 patients with refractory, or relapsed and refractory, disease who had previously failed lenalidomide and bortezomib had been enrolled at the time of the data cutoff. The primary endpoint was safety, and key secondary endpoints included pomalidomide exposure, overall response rate, or ORR, duration of response, or DOR, progression-free survival, or PFS, overall survival, or OS, and cytogenetic analyses. Patients had a median five prior therapies. All patients received thromboprophylaxis with low-dose aspirin, low-molecular-weight heparin, or equivalent. At a median follow-up of 6.8 months with a median four cycles received, the median PFS and OS were 4.2 months and 11.9 months, respectively. The ORR was 35%, with 8% of patients achieving at least a very good partial response, or VGPR. The median DOR was 6.8 months. In patients refractory to prior lenalidomide or lenalidomide and bortezomib, similar PFS, OS, and ORR were achieved.
05:22 EDTCELGCelgene reports REVLIMID study data suggests improved response rates, PFS, OS
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05:17 EDTCELGCelgene reports Vidaza Phase III study shows doubled overall survival times
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December 8, 2014
14:06 EDTCELGCelgene reports luspatercept, sotatercept increased hemoglobin levels in trials
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13:54 EDTCELGCelgene announces results from phase lll Revlimid study
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13:32 EDTPFEPfizer, 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.
11:30 EDTTEVALeerink generics pharmaceutical analyst holds analyst/industry conference call
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08:50 EDTALKSAlkermes price target raised to $63 on pipeline catalysts at Credit Suisse
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08:21 EDTTEVAMerck says looked at all risks, including patent litgation, before Cubist deal
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08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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07:36 EDTCELGAgios announces Celgene to extend discovery phase of collaboration to April 2016
Agios Pharmaceuticals (AGIO) announced that Celgene (CELG) has elected to extend the period of its exclusivity for an additional year to April 2016 under the global strategic collaboration agreement. The two companies have been working together since April 2010 to discover, develop and commercialize disease-altering therapies in oncology arising from Agios' cancer metabolism research platform. The terms of the collaboration extension are consistent with previously agreed upon financial terms. As a result of the extension, Celgene will maintain its exclusive option to drug candidates that emerge from Agios' cancer metabolism research platform through April 2016. Agios will receive a $20M payment. Following this extension, the discovery portion of the collaboration will expire on April 14, 2016. Under the terms of the original agreement announced in April 2010, Agios leads research, preclinical and early development efforts through Phase 1, while Celgene receives an option to obtain exclusive rights either upon IND acceptance or at the end of Phase 1, to further development and commercialize medicines emerging from Agios' cancer metabolism research. Celgene would lead and fund global development and commercialization of some of these drugs, and Agios would retain development and commercialization rights for certain drugs in the United States. On all programs, Agios is eligible to receive up to $120M in milestone-based payments as well as royalties on any sales.
07:17 EDTCELGCelgene price target raised to $131 from $120 at Cantor
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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.
06:47 EDTTEVAArena says Teva files marketing authorization of Belviq in Israel
Arena Pharmaceuticals (ARNA) disclosed late Friday that Teva Pharmaceutical's (TEVA) local Israeli subsidiary, Abic Marketing Limited, has filed for marketing authorization of Belviq in Israel. In connection with the filing, Arena will receive a milestone payment of $250K.
05:35 EDTCELGCelgene REVLIMID, low-dose dexamethasone increased PFS
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December 7, 2014
16:40 EDTCELGAgios announces new data from Ongoing Phase 1 trial of AG-221
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14:10 EDTCELGAmerican Society of Hematology to hold a meeting
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13:16 EDTCELGCelgene, Acceleron announced data from luspatercept phase 2 clinical trial
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December 6, 2014
09:28 EDTCELGCelgene to hold an analyst and investor event
Analyst and Investor Event being held in conjunction with the American Society of Hematology's 56th Annual Meeting in San Francisco on December 7 at 11 pm. Webcast Link
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