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News Breaks
January 9, 2014
05:08 EDTGSKGSK gains accelerated FDA approval for combination use of Mekinist, Tafinlar
GlaxoSmithKline announced that the FDA has approved Mekinist for use in combination with Tafinlar for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved test. Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma. The approval of the combination is based on the demonstration of response rate and median duration of response in a Phase I/II study. Improvement in disease-related symptoms or overall survival has not been demonstrated for Mekinist in combination with Tafinlar. The combination was approved through the FDA's Accelerated Approval programme and reviewed under a Priority Review designation. This accelerated approval is contingent on the results of the ongoing Phase III trial, which is designed to evaluate the clinical benefit of the combination in this patient population.
News For GSK From The Last 14 Days
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June 26, 2015
10:38 EDTGSKCourt revives lawsuit over GlaxoSmithKline Lamictal drug, Bloomberg reports
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June 25, 2015
14:01 EDTGSKGlaxoSmithKline initiated with a Buy at HSBC
Price target GBP 17.
June 24, 2015
13:37 EDTGSKGSK says CDC committee votedfor meningococcal group B vaccines
GlaxoSmithKline (GSK) announced that the U.S. Centers for Disease Control Advisory Committee on Immunization Practices voted for a Category B recommendation for meningococcal group B vaccination, including Bexsero, in individuals aged 16 to 23. Bexsero was approved by the FDA in January for use in individuals aged 10 through 25 years and acquired by GSK in March following the closure of the three-part transaction with Novartis (NVS).
June 23, 2015
07:25 EDTGSKPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.
June 22, 2015
07:01 EDTGSKPfizer to acquire Nimenrix, Mencevax from GlaxoSmithKline for $130M
Pfizer (PFE) announced that it has entered into an agreement with GlaxoSmithKline (GSK) to acquire its quadrivalent meningitis ACWY vaccines, Nimenrix and Mencevax, for a total consideration of approximately $130M. This transaction will add two high-quality and complementary vaccines to Pfizer’s portfolio, allowing the company to reach a broader global population. Nimenrix is a single dose meningococcal ACWY-TT conjugated vaccine designed to protect against Neisseria meningitidis, an uncommon but highly contagious disease that can lead to disability and death. Mencevax is a single-dose meningococcal ACWY unconjugated polysaccharide vaccine used to control outbreaks of meningococcal infection and for travelers to countries where the disease is endemic or highly epidemic. Pfizer does not expect this transaction to have any significant impact on its 2015 financial performance. The transaction is subject to customary closing conditions as well as regulatory approvals in several markets, and is expected to occur in the second half of 2015. Pfizer’s legal advisors for the transaction were Ropes & Gray and Clifford Chance.
June 18, 2015
13:08 EDTGSKGlaxoSmithKline management to meet with Piper Jaffray
Meeting to be held in Minneapolis on June 23 hosted by Piper Jaffray.
June 16, 2015
13:16 EDTGSKFDA appoves labeling changes for GSK anti-seizure drug
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