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News Breaks
April 8, 2014
08:46 EDTGSK, TEVATeva announces first approval, launch of generic Lovaza capsules in the U.S.
Teva (TEVA) announces the approval of the generic equivalent to Lovaza in the United States. Teva believes it is first-to-file and thus far is the only company to receive an approval from FDA. Teva plans to commence shipping immediately. Lovaza Capsules, marketed by GlaxoSmithKline (GSK), had annual sales of approximately $1.1B in the United States, according to IMS data as of December 2013.
News For TEVA;GSK From The Last 14 Days
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February 11, 2016
07:03 EDTTEVATeva sees Q1 adjusted EPS $1.32-$1.36, consensus $1.21
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07:01 EDTTEVATeva reports Q4 adjusted EPS $1.32, consensus $1.29
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05:44 EDTTEVAOptions expected to be active
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February 10, 2016
14:32 EDTTEVANotable companies reporting before tomorrow's open
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09:01 EDTTEVATeva volatility elevated into Q4 and outlook
Teva February weekly call option implied volatility is at 81, February is at 51, March is at 37; compared to its 52-week range of 20 to 41, suggesting large near term price movement into the expected release of Q4 results on February 11.
February 9, 2016
08:40 EDTGSKVBI Vaccines announces research collaboration with GlaxoSmithKline
VBI Vaccines (VBIV) has entered into a research collaboration with GlaxoSmithKline Biologicals SA (GSK) to evaluate VBI's LPV Platform. VBI's LPV Platform is a proprietary formulation and process that enables the development of vaccines and biologics with improved stability and preserved potency. Under the terms of the research collaboration, GSK has the option to negotiate an exclusive license to VBI's LPV Platform for use in a defined field. Further terms of the collaboration were not disclosed.
February 8, 2016
09:34 EDTTEVAPfizer sees decision about potential separation by no later than end 2018
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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 4, 2016
07:23 EDTGSKGSK will not be pressured into early consumer unit spinoff, Reuters says
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February 3, 2016
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
08:17 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.
08:12 EDTTEVATeva enters into collaborative research agreement with AbCellera
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08:01 EDTTEVATeva, AbCellera enter agreement to discover rare monoclonal antibodies
Teva and AbCellera have entered into a collaborative research agreement whereby AbCellera will apply its high-throughput single cell antibody platform for the discovery of rare monoclonal antibodies. Under the terms of the agreement, AbCellera will receive an upfront payment, research payments, and is eligible to receive undisclosed downstream milestones associated with the development and approval of therapeutic antibodies.
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
08:04 EDTTEVATeva Mylan not seeing same negative trends as Sandoz, says Bernstein
After Novartis (NVS) reported weak results for its generics unit, Sandoz, and blamed it on industry trends, Bernstein quotes Mylan (MYL) and Teva (TEVA) as saying that they are seeing only "slight adjustments back to normal levels" from "mildly favorable" results in 2014 and 2015. Bernstein says that Sandoz has lost a number of fairly profitable products and has had fewer approvals than its peers. Bernstein keeps Outperform ratings on Teva and Mylan.
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