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November 15, 2012
06:48 EDTGSKGlaxoSmithKline says FDA panel recommends approval of H5N1 flu vaccine
GlaxoSmithKline announced that the U.S. Food and Drug Administrationís Vaccines and Related Biological Products Advisory Committee voted unanimously 14-0 that the safety and immunogenicity data of the H5N1 adjuvanted influenza vaccine candidate supports its licensure for the active immunisation for the prevention of disease in persons 18 years of age and older who are at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine. The VRBPAC provides the FDA with independent expert advice and non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. According to agency regulations, the FDA is scheduled to conclude its review for the vaccine in December 2012. If approved, the vaccine is to be used only according to official guidance from the U.S. Government.
News For GSK From The Last 14 Days
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November 27, 2015
08:00 EDTGSKGlaxo has cut 40% of China sales reps in wake of scandal, Reuters reports
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07:34 EDTGSKGlaxoSmithKline starts phase III study of sirukumab in Giant Cell Arteritis
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November 25, 2015
11:29 EDTGSKStudy says Valeant, others exploding dermatology drug prices, WSJ reports
The JAMA Dermatology journal published a new study that found that retail prices of 19 dermatologic prescription drugs increased fivefold on average between 2009 and 2015, reported The Wall Street Journal. Targretin, marketed by Valeant (VRX), jumped to $30,320 this year from $15,708 last year and $1,687 in 2009, the study found, but "It's not just Valeant," said lead author Miranda Rosenberg. Prices for drugs made by GlaxoSmithKline (GSK) and Novartis (NVS) at least doubled or tripled over the same time frame, the report noted. Reference Link
November 24, 2015
11:16 EDTGSKAdaptimmune initiates Phase I/II trial of affinity enhanced T-cell therapy
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November 23, 2015
08:08 EDTGSKIdera Pharmaceuticals announces partnership with GSK
Idera Pharmaceuticals (IDRA) announced it has entered into an exclusive worldwide collaboration and license agreement with GSK (GSK) to research, develop and commercialize selected molecules from Idera's 3rd generation antisense platform for the treatment of selected targets in renal disease. Under the terms of the agreement, Idera is eligible to receive approximately $100M in development and regulatory milestone payments, including a $2.5M upfront payment. Additionally, Idera is eligible to receive royalties on all sales upon commercialization at varying rates up to five percent on annual net sales in excess of $500M.
November 18, 2015
08:11 EDTGSKIMS Health forecasts global drug spending to increase 30% by 2020 to $1.4T
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