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News Breaks
February 3, 2014
07:32 EDTLGND, GSKGlaxoSmithKline granted Breakthrough Therapy designation for Promacta/Revolade
Ligand Pharmaceuticals (LGND) announced that the U.S. Food and Drug Administration has granted its partner GlaxoSmithKline Breakthrough Therapy designation for Promacta/Revolade for the treatment of cytopenias in patients with severe aplastic anemia who have had insufficient response to immunosuppressive therapy. The Breakthrough Therapy designation was based on the results from an open-label, Phase II National Institute of Health study of eltrombopag in 43 heavily pre-treated SAA patients with an insufficient response to IST.
News For LGND;GSK From The Last 14 Days
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April 15, 2014
14:29 EDTGSKGlaxoSmithKline confirms FDA approval for Tanzeum
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10:14 EDTGSKFDA approves Tanzeum to treat type 2 diabetes
The Food and Drug Administration approved Tanzeum subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Tanzeum has a Boxed Warning to warn that tumors of the thyroid gland have been observed in rodent studies with some GLP-1 receptor agonists, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma, in humans. Tanzeum should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2. The FDA approved Tanzeum with a Risk Evaluation and Mitigation Strategy, which consists of a communication plan to inform health care providers about the serious risks associated with Tanzeum. Tanzeum is manufactured by GlaxoSmithKline.
08:23 EDTGSKLeerink's pharma and biotech analysts hold an analyst/industry conference call
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08:06 EDTGSKProsonix, Mylan enter licensing deal for generic version of Flixotide, Flovent
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06:32 EDTGSKPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers 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). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 14, 2014
06:40 EDTGSKGlaxoSmithKline paid bribes to Polish doctors to promote Seretide, BBC says
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April 10, 2014
11:42 EDTGSKReport claims Tamiflu, Relenza do little to prevent the spread of flu
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April 8, 2014
11:03 EDTGSKPiper Jaffray's biopharm analyst holds an analyst/industry conference call
Biopharm Analyst Schimmer discusses PCSK9 Inhibitors and other atherosclerosis approaches on an Analyst/Industry conference call. Relevant companies AEGR, ALNY, AMGN, ARNA, AZN, BMY, CBST, LLY, ESPR, GSK, ICPT, ISIS, MNKD, MRK, OREX, PFE, REGN, RHHBY, SNY and VVUS may be included on the Analyst/Industry conference call to be held on April 10 at 3 pm.
08:46 EDTGSKTeva 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.
07:22 EDTGSKCaSA-ISPE to hold a conference
21st Annual Lilfe Sciences Technology Conference is being held in Raleigh, North Carolina on April 8.
April 7, 2014
14:18 EDTGSKGlaxoSmithKline reports 14.1% stake in Applied Genetic Technologies
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April 6, 2014
16:23 EDTGSKGlaxoSmithKline investigates bribery allegations in Iraq, WSJ says
GlaxoSmithKline is investigating allegations of bribery by employees in Iraq, says the Wall Street Journal, citing emails reviewed by the publication. Reference Link
April 4, 2014
06:29 EDTGSKGlaxoSmithKline cuts China employees amid probe, WSJ reports
According to a source, as it deals with a bribery probe in Beijing, GlaxoSmithKline is cutting employees in China, the Wall Street Journal reports. It is unclear how many of Glaxo's 7,000 employees in China have been let go. Reference Link
April 3, 2014
09:37 EDTGSKAmgen to pay GlaxoSmithKline $275M to terminate denosumab collaboration pact
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April 2, 2014
09:18 EDTGSKOn The Fly: Pre-market Movers
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07:44 EDTGSKAgenus down 9.4% after GlaxoSmithKline stops MAGRITi Phase 3 trial
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06:11 EDTGSKGlaxoSmithKline confirms plans to stop MAGRIT Phase III trial
GlaxoSmithKline announced its decision to stop the MAGRITi trial, a Phase III trial of its MAGE-A3ii cancer immunotherapeuticiii in non-small cell lung cancer patients, after establishing that it will not be possible to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the treatment. Data from the trial announced on 20 March 2014 showed that it did not meet its first or second co-primary endpoints as it did not significantly extend disease-free survival when compared to placebo in either the overall MAGE-A3 positive population or in those MAGE-A3-positive patients who did not receive chemotherapy. The trial will be stopped and GSK will now gain access to the un-blinded data, in order to conduct a full assessment of the findings and understand learnings for other aspects of immunotherapy development within GSK. The Independent Data Monitoring Committee indicated that its review of the current safety information revealed no specific safety concern and the data is in line with the known safety information for the MAGE-A3 cancer immunotherapeutic.
05:45 EDTGSKAgenus announces GSK's MAGE-A3 Phase 3 study will be stopped
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