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July 3, 2014
09:42 EDTGNMSF, GSKGlaxoSmithKline, Genmab receive E.U. authorization for Arzerra
GlaxoSmithKline (GSK) and Genmab (GNMSF) announced that the European Commission has granted marketing authorization for a new indication for the use of Arzerra, or ofatumumab. The EC authorization of the first-line indication for Arzerra (ofatumumab) is based on results from two trials. One trial was a randomized, Phase III open-label, parallel-arm, multicenter, pivotal study evaluating the combination of ofatumumab and chlorambucil, versus chlorambucil alone in CLL patients for whom fludarabine-based treatment is considered inappropriate. In this study, treatment with ofatumumab and chlorambucil demonstrated a statistically significant, 71% improvement in median progression-free survival compared to chlorambucil alone. The second trial was a single-arm, multicenter, Phase II study evaluating ofatumumab in combination with bendamustine in 44 patients with previously untreated CLL for whom fludarabine-based treatment was considered inappropriate. Results of this study demonstrated that ofatumumab in combination with bendamustine provided an overall response rate of 95% and a complete response rate of 43%. Ofatumumab is also authorized in the EU for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.
News For GSK;GNMSF From The Last 14 Days
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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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November 16, 2015
14:38 EDTGNMSFGenmab confirms FDA approval of Darzalex
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