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News Breaks
December 4, 2012
07:55 EDTAMGN, AMGN, GSK, GSK, THLD, THLDThe FDA Oncologic Drugs Advisory Committee to hold a meeting
The Pediatric Oncology Subcommittee considers and discusses issues relating to development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The four products are: (1) GlaxoSmithKline's Trametinib; (2) Threshold Pharmaceuticals' TH-302; (3) Boehringer Ingelheim Pharmaceuticals' volasertib (BI 6727) and (4) Amgen's blinatumomab (MT 103 in a meeting being held at FDA Silver Springs offices on December 4 at 8 am. Webcast Link
News For AMGN;GSK;THLD From The Last 14 Days
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March 3, 2015
11:46 EDTAMGNLeerink biotech analyst holds an analyst/industry conference call
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07:08 EDTTHLDThreshold Pharmaceuticals reports Q4 EPS (12c), consensus (13c)
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March 2, 2015
16:49 EDTAMGNAmgen announces presentation of 15 abstracts from cardiovascular pipeline
Amgen announced that it will present 15 abstracts, including data evaluating, an investigational cholesterol-lowering medication, and Corlanor, an investigational drug for chronic heart failure, at the upcoming American College of Cardiology's 64th Annual Scientific Session, being held March 14-16 in San Diego. Repatha is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol, or "bad" cholesterol, from the blood. Corlanor is an oral drug that acts on the body's cardiac pacemaker to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization. Among the abstracts is a Late-Breaking Clinical Trial presentation of LDL-C lowering and major adverse cardiovascular event data after one year of treatment from the OSLER-1 and -2 studies in the Repatha program, and an oral presentation of long-term data from the OSLER-1 trial evaluating the safety and efficacy of Repatha after two years of treatment. Repatha data presentations also include a pooled safety analysis in over 6,000 patients from Phase 2 and 3 short- and long-term clinical trials. The Phase 3 results from the YUKAWA-2 study evaluating Repatha in combination with statin therapy in Japanese patients with high cardiovascular risk and high cholesterol will also be presented. Additionally, two analyses from the Phase 3 SHIFT study evaluating Corlanor will be presented. These data include an oral presentation on the efficacy profile of Corlanor in patients with chronic heart failure and angina, and a poster on whether the addition of Corlanor to optimized background therapy affects beta blocker usage.
16:15 EDTAMGNAmgen announces launch of Neulasta Delivery Kit
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09:19 EDTAMGNLigand data should establish superiority of Kyprolis, says Roth Capital
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07:17 EDTAMGNCelimmune announces Anti-IL-15 antibody licensing, option agreements with Amgen
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07:04 EDTGSKIsis Pharmaceuticals earns $15M from GlaxoSmithKline for advancing ISIS-TTR Rx
Isis Pharmaceuticals (ISIS) announced that it has earned a $15M milestone payment from GSK (GSK) related to advancing the Phase 2/3 study of ISIS-TTRRx in patients with familial amyloid polyneuropathy. ISIS-TTRRx is an antisense drug Isis is developing with GSK for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues. Including this milestone payment, Isis has generated $60 million in upfront and milestone payments for advancing ISIS-TTRRx. In addition, if GSK elects to exercise its option to exclusively license ISIS-TTRRx, Isis is eligible to receive a license fee, regulatory and sales milestone payments and double-digit royalties on sales of ISIS-TTRRx.
March 1, 2015
19:08 EDTAMGNAmgen ENDEAVOR study demonstrates superiority of Kyprolis over Velcade
Amgen and its subsidiary Onyx Pharmaceuticals announced the results from a planned interim analysis showing that the Phase 3 head-to-head clinical trial ENDEAVOR evaluating Kyprolis, carfilzomib, for Injection in combination with low-dose dexamethasone versus Velcade, bortezomib and low-dose dexamethasone met the primary endpoint of progression-free survival, PFS. Patients with relapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade. The Kyprolis combination demonstrated superiority over the Velcade combination for secondary objectives of higher overall response rate and lower neuropathy events. Overall survival data are not yet mature and continue to be monitored. Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. The rates of cardiac failure and renal failure for Kyprolis were comparable to those observed in the Phase 3 ASPIRE study. In ENDEAVOR, the rates for cardiac and renal failure were higher in the Kyprolis arm versus the Velcade arm. There was an increase in the incidence of hypertension and dyspnea in the Kyprolis arm compared to Velcade and that observed in the ASPIRE study.
February 27, 2015
09:03 EDTAMGNAmgen receives positive CHMP opinion for use of Vectibix
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the marketing authorization for Vectibix to include combination with FOLFIRI as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer. About half of the patients with mCRC have wild-type RAS tumors.The new indication is based upon the 20060314 study, which evaluated Vectibix plus FOLFIRI in the first-line setting. Vectibix is already approved in the European Union for the treatment of adult patients with wild-type RAS mCRC.
07:37 EDTAMGNAmgen removed from the short-term buy list at Deutsche Bank
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07:26 EDTAMGNFDA PDUFA Date for Amgen's Ivabradine is February 27, 2015
February 26, 2015
16:35 EDTAMGNAmgen reports EMA acceptance of Kyprolis
Amgen and its subsidiary Onyx Pharmaceuticals announced that the European Medicines Agency, or EMA, has accepted the Marketing Authorization Application, or MAA, of Kyprolis for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The MAA has been granted accelerated assessment by the EMA. Kyprolis is a proteasome inhibitor, one of the classes of drugs used to treat multiple myeloma, an incurable blood cancer affecting approximately 89,000 people in Europe. Nearly all patients with the disease experience periods of remission, followed by relapses and eventually their disease becomes resistant to treatment. The MAA includes data from the Phase 3 ASPIRE trial as well as other relevant data.
February 25, 2015
16:50 EDTAMGNAmgen reports positive results from head-To-head Phase 3 study
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12:13 EDTGSKGlaxoSmithKline sees Novartis transaction closing next week
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11:24 EDTGSKGlaxoSmithKline announces return of alli to retail stores
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February 23, 2015
13:33 EDTGSKRBS could name Howard Davies as chairman this week, FT reports
Royal Bank of Scotland (RBS) could name Howard Davies as its chairman as early as Thursday, when the bank reports its full-year results, the Financial Times reports. Davies is currently chairman of insurance business Phoenix Group and chairs Morgan Stanley's (MS) risk committee. Current RBS Chairman Philip Hampton is set to become GlaxoSmithKline's (GSK) chairman as early as this summer. Reference Link
11:17 EDTGSKFTC puts conditions on Novartis's proposed acquisition of GSK oncology drugs
According to the FTC, Global pharmaceutical company Novartis (NVS) has agreed to divest all assets related to its BRAF and MEK inhibitor drugs, currently in development, to Boulder, Colorado-based Array BioPharma (ARRY) to settle charges that Novartis’s $16B acquisition of GlaxoSmithKline’s (GSK) portfolio of cancer-treatment drugs would likely be anticompetitive...If the acquisition goes forward as proposed, Novartis would likely delay or terminate development of both its BRAF and MEK inhibitors, as well as the combination product. For that reason, Novartis’s acquisition of GSK’s portfolio of cancer-treatment drugs would likely cause significant competitive harm in the U.S. markets for both the BRAF and MEK inhibitors, ultimately raising prices for consumers and depriving them of potentially superior products. Under the terms of the proposed consent agreement, Novartis is required to provide transitional services to Array BioPharma to ensure that development of the BRAF and MEK inhibitors continues uninterrupted and that competition in BRAF and MEK inhibitor markets is not reduced. Reference Link
February 20, 2015
07:23 EDTGSKAbbVie replaces Pfizer as top global pharma pick at Jefferies
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07:08 EDTGSKAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
February 19, 2015
08:23 EDTGSKGlaxoSmithKline weakness creates buying opportunity, says Argus
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