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News Breaks
December 4, 2012
07:55 EDTAMGN, AMGN, GSK, GSK, THLD, THLDThe FDA Oncologic Drugs Advisory Committee to hold a meeting
The Pediatric Oncology Subcommittee considers and discusses issues relating to development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate. The four products are: (1) GlaxoSmithKline's Trametinib; (2) Threshold Pharmaceuticals' TH-302; (3) Boehringer Ingelheim Pharmaceuticals' volasertib (BI 6727) and (4) Amgen's blinatumomab (MT 103 in a meeting being held at FDA Silver Springs offices on December 4 at 8 am. Webcast Link
News For AMGN;GSK;THLD From The Last 14 Days
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July 25, 2014
09:19 EDTAMGNAmgen weekly volatility elevated into Q2 and outlook
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07:36 EDTAMGNEMA adopts positive opinion on new indication for Xgeva
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05:35 EDTAMGNBayer, Onyx reports NEXAVAR Phase 3 trial did not meet primary endpoint
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July 24, 2014
13:29 EDTGSKGlaxoSmithKline facing bribery allegations in Syria, Reuters says
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12:41 EDTGSKGlaxoSmithKline reports FDA approves Flonase for OTC sales in U.S.
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11:45 EDTGSKGlaxoSmithKline downgraded to Sell from Neutral at UBS
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06:13 EDTGSKGlaxoSmithKline's malaria vaccine candidate accepted for EU regulatory review
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July 23, 2014
09:33 EDTGSKGlaxoSmithKline reports record Promacta/Revolade Q2 revenue of $92M
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09:17 EDTGSKOn The Fly: Pre-market Movers
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07:19 EDTGSKGenmab reports Q2 Arzerra net sales GBP 12.8M
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07:12 EDTGSKGlaxoSmithKline lowers 2014 core EPS outlook to 'similar' to 2013
GSK now expects 2014 core EPS to be "broadly similar" to 2013 versus previous expectations of 4%-8% growth. It added, "Given impact of recent sustained strength of Sterling on free cash flow, share repurchases over balance of 2014 likely to be immaterial."
07:09 EDTGSKGlaxoSmithKline reports Q2 core EPS down 12% to 19.1p
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07:09 EDTGSKMylan wins restraining order against Apotex for generic version of GSK's Paxil
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July 22, 2014
09:55 EDTGSKLupin, private equity funds weigh bids for GSK's older drugs, Reuters reports
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July 21, 2014
07:11 EDTGSKInternational Society of DNA Vaccines to hold a conference
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July 17, 2014
16:10 EDTAMGNAmgen announces positive Phase 3 results for AMG 416
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07:18 EDTGSKMylan wins motion to enjoin GlaxoSmithKline from production of generic product
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06:23 EDTGSKGlaxoSmithKline admits to bribing Chinese officials in 2001, FT reports
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July 16, 2014
07:14 EDTGSKIsis Pharmaceuticals earns $1M milestone payment from GlaxoSmithKline
Isis Pharmaceuticals (ISIS) has earned a $1M milestone payment from GlaxoSmithKline (GSK) related to the advancement of the Phase 2/3 study of ISIS-TTRRx in patients with familial amyloid polyneuropathy. ISIS-TTRRx is an antisense drug in development with GSK for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues. Including this milestone payment, Isis has generated $27M in upfront and milestone payments for advancing ISIS-TTRRx. If GSK elects to exercise its option to exclusively license the ISIS-TTRRx program, Isis is eligible to receive a license fee, regulatory and sales milestone payments and double-digit royalties on sales of ISIS-TTRRx.
05:38 EDTGSKGSK, Theravance initiate Phase III IMPACT study
GlaxoSmithKline (GSK) and Theravance (THRX) announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the 'closed' triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease, or COPD. IMPACT is the first pivotal phase III study in a programme to evaluate a once-daily closed triple combination treatment of an inhaled corticosteroid, or ICS; a long-acting muscarinic antagonist, or LAMA; and a long-acting beta2-adrenergic agonist, or LABA, in patients with COPD. The IMPACT study will enrol approximately 10,000 patients and assess whether the combination of FF, or fluticasone furoate, an ICS, UMEC, or umeclidinium, a LAMA, and VI, or vilanterol, a LABA, all delivered in GSK's Ellipta inhaler, can reduce the annual rate of moderate and severe exacerbations compared with two approved once daily COPD treatments, Relvar/Breo Ellipta, FF/VI, which is an ICS/LABA combination, and Anoro Ellipta, UMEC/VI, which is a LAMA/LABA combination.
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