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February 15, 2013
10:21 EDTGSK, PFEViiV Healthcare granted FDA priority review for dolutegravir
ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK) and Pfizer (PFE), announced that the U.S. Food and Drug Administration has granted a priority review designation to dolutegravir submitted for the treatment of HIV infection, in combination with other antiretroviral agents, in adults and adolescents. The FDA has assigned dolutegravir a Prescription Drug User Fee Act target date of August 17, 2013. ViiV Healthcare submitted a Marketing Authorisation Application for dolutegravir to the European Medicines Agency on December 17, 2012.
News For GSK;PFE From The Last 14 Days
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April 27, 2015
14:41 EDTPFEEarnings Watch: Pfizer up over 6% since its last earnings report
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12:47 EDTPFEPfizer technical comments before earnings
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10:04 EDTGSKHigh option volume stocks
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09:03 EDTPFEChina Jo-Jo Drugstore signs incentive agreement with Pfizer subsidiary
China Jo-Jo Drugstores (CJJD) announced its subsidiary, Hangzhou Jiuzhou Grand Pharmacy Chain, has signed a new sales incentive agreement with Wyeth Pharmaceutical, a wholly owned subsidiary in China of Pfizer (PFE). The Agreement illustrated specific approaches and conditions of Jiuzhou Pharmacy's collaboration with Wyeth, including sales targets, promotional incentive to consumers, products and pricing methods. In return, Wyeth will fully support Jiuzhou Pharmacy with priority delivery, favorable purchase prices and promotional activities.
08:46 EDTGSKAgenus data positive, says JMP Securities
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08:41 EDTGSK, PFETelegraph discusses potential takeover of GSK by Pfizer
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06:19 EDTGSK, PFEPharmceutical 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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April 21, 2015
10:01 EDTPFEPfizer receives FDA breakthrough therapy designation for Xalkori
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08:18 EDTPFEPain Therapeutics resumes responsibility for Remoxy
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08:06 EDTPFEPfizer says Phase 3 inotuzumab ozogamicin study met first primary endpoint
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April 20, 2015
08:02 EDTPFEMerck KGaA, Pfizer initiate Phase III study with Avelumab
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07:20 EDTGSKAmerican Association for Cancer Research to hold annual meeting
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07:01 EDTGSKPernix Therapeutics obtains six months U.S. pediatric exclusivity for Treximet
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06:05 EDTPFEProvectus receives notice of allowance for PV-10 combined with other drugs
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April 16, 2015
09:14 EDTGSKAdamis says albuterol HFA product study met clinical FEV1 primary endpoint
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08:15 EDTGSKGlaxoSmithKline and Theravance announce launch of Anoro in Spain
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Anoro in Spain following the approval in Europe in May 2014. Anoro Ellipta is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. Anoro Ellipta is a combination of two bronchodilators, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2 agonist, in a single dry powder inhaler, the Ellipta. The approved dose of UMEC/VI is 55/22mcg. UMEC/VI has been developed under the 2002 LABA collaboration agreement between Glaxo Group Limited and Theravance.
April 15, 2015
11:53 EDTGSKGlaxoSmithKline initiated with a Sell at Societe Generale
08:04 EDTPFEPfizer: PALOMA-3 trial for IBRANCE met primary endpoint, trial stopped early
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April 13, 2015
15:12 EDTPFEMylan enters settlement, license agreement with Pfizer regarding Viagra
Mylan (MYL) announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals have entered into a settlement and license agreement with Pfizer (PFE), Pfizer Limited and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan's Abbreviated New Drug Application filed with the U.S. FDA for Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Viagra, which is indicated to treat erectile dysfunction. Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. For the 12 months ending Dec. 31, 2014, Viagra had U.S. sales of approximately $1.3B, according to IMS Health.
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