Clinical Trial Results, Litigation Outcomes and Marketing Authorizations - Research Report on Pfizer, GlaxoSmithKline, Sanofi, AstraZeneca, and Neurocrine
Sep 19, 2013, 08:00 ET
NEW YORK, September 19, 2013 /PRNewswire/ --
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Today, Investors' Reports announced new research reports highlighting Pfizer Inc. (NYSE: PFE), GlaxoSmithKline plc (NYSE: GSK), Sanofi SA (NYSE: SNY), AstraZeneca PLC (NYSE: AZN), and Neurocrine Biosciences, Inc. (NASDAQ: NBIX). Today's readers may access these reports free of charge - including full price targets, industry analysis and analyst ratings - via the links below.
Pfizer Inc. Research Report
On September 12, 2013, ViiV Healthcare, a joint company by Pfizer Inc. (Pfizer) and GlaxoSmithKline plc (GlaxoSmithKline), announced initial results from the Phase IIIb/IV FLAMINGO (ING114915) study. The Company noted that the open-label study compared once-daily regimens containing 50mg dolutegravir with once-daily regimens containing a protease inhibitor (PI) (800mg darunavir boosted with 100mg ritonavir) in treatment-naive adults with HIV-1. At the 48-week time point between the dolutegravir and darunavir-based regimens, the initial results demonstrated non-inferiority. "This is the first study in our clinical programme to compare dolutegravir to a boosted protease inhibitor in treatment-naive patients. PIs are often selected as part of a first-line regimen for treatment-naive patients, so these data provide important information regarding dolutegravir as a treatment choice for these patients," said Dr. John Pottage, Chief Medical Officer of ViiV Healthcare. The Full Research Report on Pfizer Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.investorsreports.com/report/2013-09-17/PFE]
GlaxoSmithKline plc Research Report
On September 16, 2013, GlaxoSmithKline plc (GlaxoSmithKline) announced that the US FDA has granted Priority Review designation to the Company's supplemental New Drug Applications (sNDAs) for combined use of Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E and V600 K mutation. GlaxoSmithKline informed that the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of January 8, 2014 for the Mekinist supplement, and January 9, 2014 for the Tafinlar supplement. The Full Research Report on GlaxoSmithKline plc - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.investorsreports.com/report/2013-09-17/GSK]
Sanofi SA Research Report
On September 17, 2013, Sanofi SA (Sanofi) and its subsidiary Genzyme announced that the European Commission has granted marketing authorization for Lemtrada. Genzyme informed that it plans to begin launching Lemtrada and the previously approved Aubagio in the EU soon. "The approvals of Lemtrada and Aubagio in the European Union represent an important milestone for Genzyme and demonstrate our focus on scientific innovation and commitment to multiple sclerosis patients. This is particularly exciting as the EU approval is the first for Lemtrada globally," said David Meeker, M.D., President and CEO of Genzyme. "The Lemtrada clinical trial data support its potential to meaningfully address disability in active RRMS patients, while Aubagio's efficacy, safety and convenient dosing may provide an important alternative to injectable therapies. The approvals of Lemtrada and Aubagio represent a significant step forward in the way we think about treating this disease," added Hans-Peter Hartung M.D., Ph.D., Professor and Chairman of the Department of Neurology at Heinrich-Heine-University in Duesseldorf, Germany. The Full Research Report on Sanofi SA - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.investorsreports.com/report/2013-09-17/SNY]
AstraZeneca PLC Research Report
On September 13, 2013, AstraZeneca PLC (AstraZeneca) announced that the US Court of Appeals for the Federal Circuit (Federal Circuit) has issued a temporary injunction against the US launch of the 505(b)2 NDA Esomeprazole Strontium product of Hanmi Pharmaceutical (Hanmi). Previously, in June 2013, AstraZeneca had entered into an agreement with Hanmi and Amneal Pharmaceuticals (Amneal) to streamline litigation issues on the proposed Esomeprazole Strontium and, in July 2013, AstraZeneca had filed a Notice of Appeal for the Federal Circuit, with the Company seeking a reversal of claim construction. According to the release, Hanmi received US FDA approval for Esomeprazole Strontium on August 6, 2013. The Full Research Report on AstraZeneca PLC - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.investorsreports.com/report/2013-09-17/AZN]
Neurocrine Biosciences, Inc. Research Report
On September 9, 2013, Neurocrine Biosciences, Inc. (Neurocrine) announced Phase IIb results for the 50mg dose of NBI-98854, a small molecule VMAT2 inhibitor in development for tardive dyskinesia. According to the results, the 50 mg dose in Phase IIb Kinect study did not meet the primary endpoint, while the 100mg dose showed a statistical and clinically significant improvement. "Although this was not the result we anticipated in the 50mg dose based on the data set from the earlier clinical studies, we were pleased to see a clear dose related response at the end of Week 2, with the 100mg dose," said Kevin C. Gorman, President and CEO of Neurocrine. "The 100mg dose was statistically superior to placebo as well as providing a clinically significant improvement in tardive dyskinesia symptoms and importantly a very good safety profile. We will now perform an additional Phase II study utilizing 100mg and higher doses." The Full Research Report on Neurocrine Biosciences, Inc. - including full detailed breakdown, analyst ratings and price targets - is available to download free of charge at: [http://www.investorsreports.com/report/2013-09-17/NBIX]
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