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Stock Market & Financial Investment News

News Breaks
April 3, 2014
09:37 EDTGSK, AMGNAmgen to pay GlaxoSmithKline $275M to terminate denosumab collaboration pact
Amgen (AMGN) disclosed in a regulatory filing that the company and Glaxo Group (GSK) entered into an agreement terminating in part and amending in part the collaboration agreement dated as of July 27, 2009 relating to the commercialization of denosumab for osteoporosis indications in certain geographic territories. The transition agreement terminates the prior collaboration agreement for all countries and regions of the collaboration territory, including the European Union, Switzerland, Norway, Russia and Mexico, except for Australia. All commercial activities assigned to GSK under the collaboration agreement other than those in Australia will be transitioned back to Amgen no later than December 31. In exchange for the early termination, except Australia, Amgen will pay to GSK an initial payment and specific milestones over the transition period totaling $275M. In addition, Amgen will reimburse GSK $15M for costs incurred by GSK in performing its obligations. The transition agreement does not change the terms of the separate expansion agreement dated as of July 27, 2009 relating to the commercialization of denosumab for all indications in certain geographic territories, Amgen said.
News For AMGN;GSK From The Last 14 Days
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February 8, 2016
15:59 EDTAMGNU.K. cost regulator reverses stance on Amgen's Repatha, PharmaTimes says
The U.K.'s National Institute for Health and Care Excellence has reversed its prior decision barring patients from accessing Amgen's cholesterol treatment Repatha, reports PharmaTimes. The agency will now allow use of the drug, alone or in combination with other therapies, for various classes of patients, though only at a 140mg biweekly dose and only as long as the company continues to offer certain discounts, the report noted. Reference Link
08:10 EDTGSKOncoMed: FDA says PINNACLE trial should continue under supervision
Following notification of the ALPINE DSMB's findings, OncoMed (OMED) initiated interactions with tarextumab clinical investigators, partner GlaxoSmithKline (GSK), the FDA and the PINNACLE trial's DSMB chairperson to assess potential impact of these results on the overall development program, including the ongoing Phase 2 PINNACLE trial in small-cell lung cancer patients. PINNACLE trial investigators received an addendum to the informed consent form that included a description of the interim analysis from ALPINE. The FDA and the PINNACLE DSMB were provided unblinded data from both Phase 2 trials, a description of OncoMed's exploratory analysis of the ALPINE results and related trial materials for review. The independent analyses of the FDA and PINNACLE DSMB indicated that the PINNACLE trial could continue under the supervision of the PINNACLE DSMB monitoring for safety and efficacy and that appropriate safeguards are in place. OncoMed is conducting the PINNACLE Phase 1b/2 clinical trial of tarextumab for the treatment of small cell lung cancer. The randomized Phase 2 trial is comparing progression-free survival outcomes for patients treated with tarextumab administered at 15 mg/kg every three weeks in combination with etoposide and cisplatin or carboplatin versus patients who receive placebo plus chemotherapy. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary endpoints for the Phase 2 study include overall survival, overall response rate, pharmacokinetics, safety and other biomarkers. The PINNACLE study is being conducted at about 40 sites in the U.S. and is expected to enroll approximately 130 patients. Results from the Phase 2 PINNACLE trial are anticipated in 2017.
07:03 EDTGSKBiogen joins Centre for Therapeutic Target Validation
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06:28 EDTGSKPharma trade group rolls out ad campaign aimed at lawmakers, WSJ says
The pharmaceutical industry is launching a new ad campaign with the intention of improving its reputation with lawmakers in an effort to lobby against drug price restrictions, the Wall Street Journal reports. The industry's biggest trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, says it plans to spend several million dollars this year, and 10% more than it spent last year, on digital, radio, and print advertisements that highlight the sector's role in developing new drugs and advancing medical science, the report says. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Reference Link
February 5, 2016
09:26 EDTAMGNLeerink biotech analyst holds an analyst/industry conference call
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06:03 EDTAMGNAmgen resumed with a Market Perform at Leerink
Leerink analyst Geoffrey Porges resumed coverage of Amgen with a Market Perform rating and $179 price target.
February 4, 2016
19:15 EDTAMGNAmgen reinitiated with a Market Perform at Leerink
Target $179.
16:28 EDTAMGNAmgen reports BLINCYTO study met primary endpoint, stopped early for efficacy
Amgen announced that the results of a prespecified interim analysis showed that the primary endpoint of improved overall survival was met in the Phase 3 TOWER study. The randomized, open-label TOWER study evaluated the efficacy of BLINCYTO versus standard of care in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The independent data monitoring committee recommended, and Amgen has accepted, that the study end early for efficacy. The BLINCYTO adverse events observed in the TOWER study were consistent with the known safety profile of BLINCYTO. Secondary endpoints are currently being evaluated.
16:02 EDTAMGNAmgen says trial of Repatha meets co-primary endpoints
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07:23 EDTGSKGSK will not be pressured into early consumer unit spinoff, Reuters says
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February 3, 2016
08:57 EDTAMGNPullback in biotech makes M&A more attractive, says UBS
UBS analyst Andrew Peters noted the pullback in small and mid-cap biotechs and said a consequence of the lower valuations may be an increased appetite for M&A by the larger firms. Peters noted Gilead (GILD) commented on its earnings call that "there's no question" the pullback has made M&A more attractive. UBS said with valuations so far off their highs, the question remains whether management and boards will accept deals at such depressed levels.
08:48 EDTAMGNWorkday appoints Diana McKenzie as Chief Information Officer
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07:23 EDTGSKGlaxoSmithKline confirms 2015 ordinary dividend of 80p, special dividend of 20p
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07:23 EDTGSKGlaxoSmithKline sees double digits CER FY16 core EPS percentage growth
If FX rates held at January average levels estimated impact of +5% on 2016 Sterling core EPS growth.
07:21 EDTGSKGlaxoSmithKline reports Q4 EPS (7.3p) vs. 21.5p last year
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February 2, 2016
08:53 EDTAMGNPiper Jaffray biopharma analyst holds an analyst/industry conference call
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08:17 EDTGSKAdaptimmune, GSK expand strategic immunotherapy collaboration
Adaptimmune Therapeutics (ADAP) and GlaxoSmithKline (GSK) announced that the companies have expanded the terms of their strategic collaboration agreement to accelerate Adaptimmune's lead clinical cancer program, an affinity enhanced T-cell immunotherapy targeting NY-ESO-1, toward pivotal trials in synovial sarcoma. Adaptimmune and GSK announced a strategic collaboration and licensing agreement in June 2014 for up to five programs, including the lead NY-ESO TCR program. GSK has an option on the NY-ESO-1 program through clinical proof of concept and, on exercise, will assume full responsibility for the program.
07:42 EDTGSKPressure mounts on big pharma names to shrink, sharpen focus, FT says
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06:32 EDTGSKGSK, J&J back Index Ventures' $1B biotech business spinoff, Reuters says
GlaxoSmithKline (GSK) and Johnson & Johnson (JNJ) will back a new spinoff from Index Ventures, which is spinning off its biotech portfolio into a new $1B entity, Reuters reports. The New Medicxi Ventures business will be helmed by the existing life sciences team from Index and will include all the current biotech portfolio firms, the report says. Medicxi raises $229M for a new fund in Europe with GSK and J&J each putting in 25%, Reuters reports. Reference Link
February 1, 2016
08:25 EDTAMGNAlder pullback Friday a buying opportunity, says Leerink
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