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News Breaks
May 30, 2014
11:10 EDTGNMSF, GSKGenmab says Glaxo to start additional pivotal studies with ofatumumab
Genmab A/S (GNMSF) announced its collaboration partner GlaxoSmithKline (GSK) has taken the decision to start additional pivotal studies with the subcutaneous formulation of ofatumumab. Phase III studies of subcutaneous ofatumumab in RRMS are expected to begin in 2015, following encouraging data from a Phase II study reported in October 2013.In addition, GSK plans to file an IND for a potential pivotal study of subcutaneous ofatumumab in NMO, a rare autoimmune disorder which affects the optic nerve and spinal cord, in 2014. Further details about the RRMS and NMO programs will be available in due course. A Phase III study of subcutaneous ofatumumab in pemphigus vulgaris, a rare autoimmune disorder of the skin, was announced in 2013.
News For GSK;GNMSF From The Last 14 Days
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May 5, 2015
15:02 EDTGSKNotable companies reporting before tomorrow's open
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09:31 EDTGSKGlaxoSmithKline, partners make EU submission for gene therapy to treat ADA-SCID
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May 3, 2015
18:11 EDTGSKSiemens investigated by Chinese regulator last year, Reuters says
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May 1, 2015
07:43 EDTGSKExpensive drugs drove over 25% of 2013 Medicare drug spending, WSJ says
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April 30, 2015
16:59 EDTGSKGlaxoSmithKline, Theravance announce FDA approval of Breo Ellipta
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15:20 EDTGSKGlaxo says FDA issued CRL on use of Breo Ellipta in patients aged 12-17
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15:17 EDTGSKGlaxoSmithKline says FDA approves BREO ELLIPTA for adults with asthma
GlaxoSmithKline (GSK) and Theravance (THRX) announced that the FDA has approved BREO ELLIPTA for the once-daily treatment of asthma in patients aged 18 years and older. Breo Ellipta is not indicated for the relief of acute bronchospasm. Breo is a fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol. Two strengths, 100/25mcg and 200/25mcg, have been approved in the US for use in asthma, administered once-daily using the Ellipta dry powder inhaler.
07:21 EDTGSKFDA PDUFA Date for Theravance BREO ELLIPTA is April 30, 2015
April 27, 2015
10:27 EDTGNMSFGenmab announces Phase III study of Arzerra met primary endpoint
Genmab announced that the top-line results from the Phase III COMPLEMENT 2 study showed that treatment with Arzerra plus fludarabine and cyclophosphamide met the primary endpoint of improved progression-free survival in patients with relapsed CLL compared to those given fludarabine and cyclophosphamide alone. The safety profile observed in this study was consistent with other trials of ofatumumab and no new safety signals were observed.
10:04 EDTGSKHigh option volume stocks
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08:46 EDTGSKAgenus data positive, says JMP Securities
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08:41 EDTGSKTelegraph discusses potential takeover of GSK by Pfizer
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06:19 EDTGSKPharmceutical companies buy drugs and raises prices, WSJ reports
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April 24, 2015
07:11 EDTGSKAgenus: GSK's RTS,S vaccine showed statistically significant results in study
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