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News Breaks
June 26, 2013
11:08 EDTMYL, PFEMylan launches generic Viagra in 11 European countries
Mylan (MYL) announced that it has launched Sildenafil Citrate Tablets, 25 mg, 50 mg and 100 mg in France, the United Kingdom, Ireland, Italy, Belgium, Slovakia, Germany, Denmark, Czech Republic, Spain and the Netherlands. Mylan has received marketing authorization from each country's respective health authority to begin selling its product immediately. Sildenafil Citrate is the generic version of Pfizer's (PFE) Viagra. This product is indicated for the treatment of erectile dysfunction. Viagra had total sales of EUR 241.1M (USD 310.4M) in France, the United Kingdom, Ireland, Italy, Belgium, Slovakia, Germany, Denmark, Czech Republic, Spain and the Netherlands for the twelve months ending March 31, 2013, according to IMS Health.
News For MYL;PFE From The Last 14 Days
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January 27, 2015
07:16 EDTPFEPfizer drops 2.7% after FY15 outlook miss expectations
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07:07 EDTPFEPfizer sees FY15 adjusted EPS $2.00-$2.10, consensus $2.18
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07:01 EDTPFEPfizer reports Q4 adjusted EPS 54c, consensus 53c
Reports Q4 revenue $13.1B, consensus $12.9B.
January 26, 2015
16:15 EDTPFEPfizer commits to lower price for Prevenar 13 in developing countries
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15:40 EDTPFENotable companies reporting before tomorrow's open
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13:29 EDTPFEEarnings Preview: Pfizer set to report Q4 results as generics impact Celebrex
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11:00 EDTMYLMylan expands Hepatitis C licensing agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited is expanding its hepatitis C licensing agreement with Gilead Sciences (GILD) to include the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816, once approved, in 91 developing countries. The single tablet regimen is being evaluated in Phase 3 clinical studies for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first all-oral single tablet regimen for all hepatitis C genotypes. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available. This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead in September 2014, which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/sofosbuvir in 91 developing countries. Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.
January 23, 2015
16:08 EDTPFETeva volatility elevated, Pfizer approached late last year, Bloomberg says
Teva (TEVA) overall option implied volatility of 25 compares to its 26-week average of 23 according to Track Data, suggesting large price movement into Pfizer (PFE) approach late last year, Bloomberg says.
16:04 EDTPFETeva rebuffed Pfizer approach late last year, Bloomberg says
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January 22, 2015
11:23 EDTPFEPfizer says CHMP adopted positive opinion on Prevenar 13 expansion
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January 21, 2015
12:30 EDTPFEGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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January 20, 2015
14:37 EDTMYLTeva generic competition to Copaxone pushed out by ruling, says BMO Capital
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12:56 EDTMYLMylan says continues to believe '808 patent is 'invalid'
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10:40 EDTMYLMomenta Pharma sinks after Supreme Court rules on Copaxone
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January 15, 2015
14:31 EDTMYLMylan launches generic Epivir-HBV tablets
Mylan (MYL) announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's (GSK) Epivir-HBV. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Lamivudine Tablets, 100 mg, had U.S. sales of approximately $18.1M for the 12 months ending September 30, 2014, according to IMS Health. Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
11:20 EDTPFEGoldman cuts J&J to sell citing competitive pressures
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07:59 EDTPFEAmerican Society of Clinical Oncology to hold a symposium
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