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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
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March 20, 2015
09:47 EDTGSKGlaxoSmithKline, Theravance launch Revlar Ellipta in Italy
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Revlar Ellipta in Italy following the recent approval by the Italian regulatory authorities in December 2014. Relvar is a fixed dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol. The components will be administered using the Ellipta, a dry powder inhaler. In Italy, the product is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product is appropriate; and for the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease with a FEV1<70% predicted normal post-bronchodilator with an exacerbation history despite regular bronchodilator therapy.
09:06 EDTAMGNAmgen submits application for marketing approval for RepathaTM in Japan
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07:41 EDTAMGNAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
18:14 EDTGSKGlaxoSmithKline, Theravance announce FDA panel outcome on Breo Ellipta
GlaxoSmithKline (GSK) and Theravance (THRX) announced the outcome of the joint meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the United States FDA regarding the supplemental New Drug Application for Breo Ellipta as a once-daily inhaled treatment for asthma in patients aged 12 years and older. The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against). The Committee voted that the efficacy data provides substantial evidence of a clinically meaningful benefit in adults (18 for, 2 against) and that the safety in this population has been adequately demonstrated (17 for, 3 against). The Committee voted against approval for the proposed indication in 12-17 year olds (2 for, 18 against). The Committee voted that the efficacy data was not sufficient to demonstrate the benefit (4 for, 16 against) and the safety (1 for, 19 against) has not been adequately demonstrated in this sub-population. The Committee recommended that a large LABA safety trial with FF/VI should be required in adults (13 yes, 7 no) and in 12-17 year olds (17 yes, 2 no and 1 no-vote), similar to the ongoing LABA safety trials being conducted as an FDA Post-Marketing Requirement by each of the manufacturers of LABA containing asthma treatments. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA. Based on these opinions and the data presented, the FDA will make its final decision on approval, which is expected on April 30.
15:55 EDTAMGNAmgen injunction bid for Neupogen biosimilar denied, Reuters reports
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15:13 EDTAMGNAmgen denied preliminary injunction for biologics against Novartis, Reuters says
15:12 EDTGSKFDA panel says Breo lacks efficacy data in children with asthma, Bloomberg says
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07:26 EDTGSKFDA to hold a joint advisory committee meeting
The Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety & Risk Management Advisory Committee discuss the supplemental New Drug Application (sNDA) 204275-S001, for fluticasone furoate and vilanterol dry powder for inhalation (with the brand name of BREOŽ ELLIPTAŽ), sponsored by Glaxo Group Limited (d/b/a GSK) for the once-daily treatment for asthma in patients aged 12 years and older in a meeting being held in Gaithersburg, Maryland on March 19 at 8 am. Webcast Link
07:10 EDTGSKTheravance announces trading in common stock halted as FDA meets on sNDA
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March 17, 2015
16:11 EDTAMGNAmgen to present 10 abstracts from dermatology portfolio
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07:07 EDTGSKVeeva says selected by GlaxoSmithKline for multichannel CRM
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07:06 EDTGSKVeeva selected by GSK as global multichannel CRM partner
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March 16, 2015
08:52 EDTAMGNAmgen to hold a conference call
Conference call to provide an update from the 73rd Annual Meeting of AAD will be held on March 23 at 3 pm. Webcast Link
08:35 EDTAMGNAmgen to hold a conference call
Executive Vice President of R&D, Sean Harper, discusses Amgen's cardiovascular program, including the Repatha data currently being presented at the American College of Cardiology's Scientific Session & Expo, on a conference call to be held on March 16 at 4 pm. Webcast Link
08:23 EDTAMGNPCSK9 data continues to impress, says Leerink
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07:32 EDTGSKEmergent BioSolutions signs agreements with GSK, Oxford University, NIAID
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06:57 EDTAMGNAmgen clinical data very positive, says RBC Capital
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06:40 EDTAMGNPCSK9 studies show potential improvement in heart health, WSJ says
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March 15, 2015
13:11 EDTAMGNAmgen publishes safety analysis of Repatha in New England Journal of Medicine
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12:53 EDTAMGNAmgen announces new data from study of Repatha in combination with statins
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