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Stock Market & Financial Investment News

News Breaks
April 10, 2014
11:42 EDTGILD, GSK, RHHBYReport claims Tamiflu, Relenza do little to prevent the spread of flu
The Cochrane Collaboration, an independent nonprofit organization that aims to help health professionals, patients, and policy makers access evidence-based medicine to guide their decisions, concluded in a newly published report that neuraminidase inhibitors Tamiflu and Relenza are stockpiled and recommended by public health agencies but have not been proven to prevent the spread of flu or reduce dangerous complications. Tamiflu was co-developed by and is marketed by Gilead Sciences (GILD) and Roche (RHHBY), while Relenza is marketed by GlaxoSmithKline (GSK). Roche said "we disagree with the overall conclusions" and warned they could "potentially have serious public health implications," according to a company statement quoted by BBC News. Reference Link
News For GILD;RHHBY;GSK From The Last 14 Days
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August 27, 2015
07:51 EDTRHHBYRoche catching up fast to Bristol-Myers in immuno-oncology, says Jefferies
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August 26, 2015
17:06 EDTGSK, GILDGilead AMBITION study results published in New England Journal of Medicine
Gilead Sciences (GILD) announced detailed results from the AMBITION study. In AMBITION, conducted in collaboration with GlaxoSmithKline (GSK), combination therapy with Letairis and tadalafil reduced the risk of clinical failure by 50% compared to the pooled Letairis and tadalafil monotherapy arm. These data were published in The New England Journal of Medicine. Letairis, a selective endothelin type-A receptor antagonist, and tadalafil, a PDE5 inhibitor, are each approved in the United States, the European Union and other countries as once-daily treatments for patients with pulmonary arterial hypertension with WHO/NYHA functional class II and III symptoms. Letairis is indicated in the U.S. to improve exercise ability and delay clinical worsening and in the EU under the tradename Volibris to improve exercise capacity. Tadalafil 40 mg is indicated in the U.S. and the EU to improve exercise ability and capacity, respectively. Preclinical data have suggested these therapies may have synergistic effects. However, combination use with Letairis and tadalafil is currently not approved.
August 25, 2015
19:34 EDTGILDExperts tell White House to expand use of Hepatitis C drugs, NYT says
Health care experts from the Public Health Service and the Advisory Council on H.I.V./AIDS have recommended that Medicaid officials expand the use of costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni, reports the New York Times, citing correspondence sent to the White House. The advisory council said current usage limitations on the drugs are "unreasonable," but it also suggested that manufacturers disclose drug development costs in the face of the significant price tags on modern Hepatitis C treatments. Reference Link
August 24, 2015
13:36 EDTGILDBiotech correction presents some opportunities, says RBC Capital
RBC Capital analyst Michael Yee said he won't try to pick the short-term bottom in biotech, but contends that any macro weakness in China shouldn't have any major impact to financials or fundamentals for the sector given their minimal exposure there. If the market continues to be volatile, Yee recommends a focus on names with defensive characteristics, such as higher margins and free cash flow yield, naming Amgen (AMGN), Celgene (CELG) and Gilead (GILD) as some examples. The analyst adds that he likes Vertex (VRTX) on the pullback for "more aggressive" growth investors. Yee has Outperform ratings on all of the stocks mentioned above.
13:15 EDTGSKFDA expands use of Novartis' Promacta to include children ages 1 and older
Ligand Pharmaceuticals (LGND) announced that the FDA has approved an expanded use for Promacta, a Novartis (NVS) product, to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was acquired by Novartis in March from GlaxoSmithKline (GSK). Promacta was discovered as a result of research collaboration between GSK and Ligand Pharmaceuticals and was developed by GSK. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. The label expansion of Promacta was based on data from two double-blind, placebo-controlled trials, including the largest Phase 3 clinical trial in this patient population. Treatment with Promacta significantly increased and sustained platelet counts among pediatric patients with chronic ITP with an insufficient response to prior chronic ITP therapies, and some patients taking concomitant ITP medications were able to reduce or discontinue their use of these medications, primarily corticosteroids. Promacta should be used only in those whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
12:01 EDTRHHBYRoche buys nucleic acid purification technology from Lumora
Roche has signed a definitive asset purchase agreement with Lumora for products associated with the patent-protected Heat Elution technology for nucleic acid purification of multiple sample types including challenging formalin-fixed paraffin-embedded tumor samples. Roche plans to explore integrating this technology into its sequencing workflow solution.
August 23, 2015
12:35 EDTRHHBYBiotech firms could see 'billions' in sales from new cancer drugs, Barron's says
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August 21, 2015
09:38 EDTRHHBYUBS global healthcare analysts hold an analyst/industry conference call
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05:25 EDTGSKNovartis acquires all remaining rights to Ofatumumab from GSK
Novartis (NVS) announced that it has entered into an agreement to acquire all remaining rights to Ofatumumab from GlaxoSmithKline (GSK). Ofatumumab, a fully human monoclonal antibody which targets CD20, is being developed for relapsing remitting multiple sclerosis, or RRMS, and other autoimmune indications. Novartis previously acquired the rights to Ofatumumab for oncology indications and it is marketed under the brand name Arzerra. Novartis will be responsible for the worldwide development, regulatory and commercialization activities for Ofatumumab. Under the terms of the agreement, Novartis will make an initial upfront payment of $300M to GSK for the acquisition of the compound and a further payment of $200M payable following the start of a phase III study in MS by Novartis. Upon completion of pre-determined milestones, contingent payments of up to $534M may be made. Novartis will also pay royalties of up to 12% to GSK on any future net sales of Ofatumumab in autoimmune conditions.
August 20, 2015
16:34 EDTGILDGilead MAA for HIV regimen has been fully validated by EMA
Gilead Sciences announced that the company's Marketing Authorization Application, MAA, for an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg has been fully validated and is now under evaluation by the European Medicines Agency, EMA. Emtricitabine and tenofovir alafenamide are marketed by Gilead Sciences and rilpivirine is marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The data included in the application support the use of R/F/TAF for the treatment of HIV-1 infection in adults and pediatric patients 12 years and older. "With this validation, R/F/TAF is now the third TAF-based filing under review by the EMA as we advance a portfolio of new treatment options that may offer high efficacy and favorable safety profiles," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "The R/F/TAF filing also represents the next step in our collaboration with Janssen to develop HIV treatments that potentially meet the diverse needs of people living with HIV."
August 17, 2015
05:14 EDTRHHBYGenentech reports atezolizumab pivotal Phase II study met primary endpoint
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August 14, 2015
17:17 EDTGILDPoint72 gives quarterly update on stakes
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06:19 EDTGSKGlaxoSmithKline says NC plant meds safe from Legionnaires' bacteria, AP reports
GlaxoSmithKline said that the medications manufactured at its pharmaceutical plant in Zebulon, North Carolina are safe despite the company's decision to shut down the factory after the discovery of Legionnaires' bacteria, the Associated Press reports, citing an email from company spokeswoman Jenni Brewer Ligday. North Carolina health officials have said that no cases of Legionnaires' disease linked to the Glaxo plant have been reported, the report says. Reference Link

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