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Stock Market & Financial Investment News

News Breaks
April 1, 2013
14:32 EDTGSKGlaxoSmithKline: FDA recommends removing warning statements on NRT products
The U.S. FDA announced a recommendation to remove certain warning statements and modifications of the instructions for use of nicotine replacement therapy products. As leaders in smoking cessation, GlaxoSmithKline Consumer Healthcare commends the FDA on this action and believes this is a positive step to help more smokers quit and will work with the FDA to implement these changes to our product labeling as soon as possible. The changes help eliminate barriers for smokers and include updates to the warnings and directions sections in the current label.
News For GSK From The Last 14 Days
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April 22, 2014
09:16 EDTGSKOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Netflix (NFLX), up 8%... Harley-Davidson (HOG), up 7%... PLX Technology (PLXT), up 8%... Illinois Tool (ITW), up 2.3%... Comcast (CMCSA), up 1%... McDonald's (MCD), up 0.6%. ALSO HIGHER: Allergan (AGN), up 17% after Valeant (VRX) confirms proposal to combine with the company for $48.30 and 0.83 shares of stock. Valeant is up 5% following its confirmation of the news that broke last night... GlaxoSmithKline (GSK), up 4.5% after agreeing to sell oncology products for $14.5B to Novartis (NVS) and buy Novartis' Vaccines business, currently excluding its flu business, for $7.1B plus royalties. Novartis shares trading in New York are also up 1% following the deals... Revance Therapeutics (RVNC), up 20% after announcing positive results from RT002 Phase 1/2 study... Facebook (FB), up 2% following upgrade at Credit Suisse. DOWN AFTER EARNINGS: Xerox (XRX), down 4%... Lexmark (LXK), down 4.8%. ALSO LOWER: Allison Transmission (ALSN), down 4% after filing to sell 25M shares for holders... FireEye (FEYE), down 2.9% after filing to sell 13.3M shares of common stock for holders... Bebe stores (BEBE), down 16% after reporting preliminary Q3 losses that were steeper than the consensus estimate.
08:49 EDTGSKGSK, Theravance announce Phase III study of FF/VI in Japan
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08:37 EDTGSKTheravance, GlaxoSmithKline receive Australian approval for Breo Ellipta
GlaxoSmithKline (GSK) and Theravance (THRX) announced that the Therapeutic Goods Administration has approved BREO ELLIPTA for the treatment of patients with asthma or chronic obstructive pulmonary disease, or COPD, in Australia. Two strengths of BREO ELLIPTA have been licensed for the treatment of asthma and one strength has been licensed for the treatment of COPD.
07:48 EDTGSKGlaxoSmithKline to host conference call
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07:46 EDTGSKGlaxo thinks Novartis agreement could mean future disposals, Reuters says
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05:35 EDTGSKNovartis says transactions 'represent a transformation' for the company
The elements of the transaction with GSK (GSK) are inter-conditional and subject to approval by GSK shareholders. The Novartis (NVS) board unanimously believes that the transactions with GSK and the transaction with Lilly (LLY) are in the best interests of Novartis and the Novartis Shareholders as a whole. The transaction with Lilly is expected to close by the end of 1Q15 and the transaction with GSK is expected to close during the first half of 2015. The terms of the divestment of the Vaccines business would maximize the value of its pipeline, including Bexsero. The divestment of Animal Health would recognize the full value of the business. The transactions are expected to improve Novartis' sales and core operating income growth rates, while improving margins. Each of the transactions is projected to be value creating. The company commented, "These transactions represent a transformation for Novartis. We have leading positions in our core businesses in high-growth segments of healthcare. This will enable us to continue to build the world's most respected and successful healthcare company. Our strategic focus on science-based innovation and our global scale position the company well to meet the changes in the healthcare industry for the coming decade and beyond."
05:26 EDTGSKNovartis OTC, GSK Consumer Healthcare form joint venture
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05:23 EDTGSKNovartis divests Vaccines business to GSK for $7.1B
Novartis (NVS) has agreed to divest its Vaccines business to GSK (GSK), currently excluding its flu business, for $7.1B plus royalties. The $7.1B consists of $5.25B upfront and up to $1.8B in milestones. As a part of a value-maximization strategy in the context of the portfolio review, Novartis has initiated a separate sales process for its flu business.
05:20 EDTGSKNovartis to acquire GSK oncology products for $14.5B
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April 17, 2014
15:55 EDTGSKGlaxoSmithKline, Genmab get FDA approval for Arzerra use
GlaxoSmithKline (GSK) and Genmab (GNMSF) announced that the U.S. FDA has approved a Supplemental Biologic License Application for the use of Arzerra, a CD20-directed monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia for whom fludarabine-based therapy is considered inappropriate. The FDA approval of the first-line indication is based on results from a Phase III study which demonstrated statistically significant improvement in median progression-free survival in patients who received the combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.
15:03 EDTGSKFDA grants wider approval for Glaxo's Arzerra in treatment of CLL
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11:43 EDTGSKGlaxoSmithKline announces Canadian approval for Incruse Ellipta
GlaxoSmithKline announced that Incruse Ellipta has received market authorization in Canada for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, or COPD, including chronic bronchitis and emphysema. This is the first market authorization granted for this product anywhere in the world, the company noted.
07:20 EDTGSKGlaxoSmithKline opens internal probe of bribery allegations, WSJ says
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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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