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News Breaks
December 19, 2012
16:12 EDTFOLD, GSKAmicus Theraputics and GlaxoSmithKline report results from Phase 3 Fabry study
Amicus Therapeutics (FOLD) and GlaxoSmithKline (GSK) announced the 6-month primary treatment period results from the first Phase 3 global registration study of investigational oral migalastat HCl monotherapy in males and females with Fabry disease who had genetic mutations identified as amenable to migalastat HCl in a cell-based assay. The pre-designated primary endpoint was the number of patients who demonstrated a 50% or greater reduction in kidney interstitial capillary globotriaosylceramide-3 after 6 months of treatment with migalastat HCl compared to placebo. 13/32 (41%) in the migalastat HCl treatment group achieved the endpoint versus 9/32 (28%) in the placebo group. This difference did not achieve statistical significance. A pre-specified secondary analysis assessing the absolute percent change in kidney interstitial capillary GL-3 from baseline to month 6 showed a median reduction of 41% in the migalastat HCl group versus a median reduction of 6% in the placebo group. To date, no drug-related serious adverse events have been observed.
News For FOLD;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
16:04 EDTFOLDAmicus says EMA validates Galafold marketing authorization application
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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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