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Stock Market & Financial Investment News

News Breaks
July 16, 2014
09:03 EDTMYL, ABT, SNYSanofi held talks on mature drugs with Abbott, Mylan, PE firms, Reuters says
Sanofi (SNY) has shopped an $8.5B portfolio of mature drugs to Abbott (ABT), Mylan (MYL) and private equity firms, according to Reuters, citing an internal company document circulated by the CGT union. Sanofi is considering whether to sell, carve out or create a joint venture for the portfolio of about 200 drugs, but a Sanofi spokesman said no decision has yet been made, the report noted. Reference Link
News For SNY;ABT;MYL From The Last 14 Days
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January 29, 2015
09:13 EDTABT, MYLAbbott sees 6% negative impact to FY sales from forex
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07:50 EDTABTAbbott sees Q1 EPS excl items 41c-43c, consensus 41c
07:50 EDTABTAbbott sees FY15 EPS excl items $2.10-$2.20, consensus $2.14
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07:50 EDTABTAbbott reports Q4 Nutrition sales up 8.9% to $1.8B
Reports Q4 Diagnostics sales up 8.6% to $1.23B; Reports Q4 Established Pharmaceuticals sales up 35.4% to 922M; Reports Q4 Medical Devices sales up 0.4% to $1.38B.
07:48 EDTABTAbbott expects top tier earnings growth in 2015 despite currency headwinds
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07:47 EDTABTAbbott reports Q4 EPS excl items 71c, consensus 67c
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January 28, 2015
15:38 EDTABTNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Celgene (CELG), consensus 99c... ConocoPhillips (COP), consensus 59c... Abbott Laboratories (ABT), consensus 67c... Occidental Petroleum (OXY), consensus 68c... Colgate-Palmolive (CL), consensus 74c... Ford (F), consensus 23c... Dow Chemical (DOW), consensus 69c... Alibaba (BABA), consensus 75c... Thermo Fisher (TMO), consensus $1.94; Time Warner Cable (TWC), consensus $2.09... Phillips 66 (PSX), consensus $1.34... Alexion Pharmaceuticals (ALXN), consensus $1.29... Baxter International (BAX), consensus $1.31... Cardinal Health (CAH), consensus $1.10... Raytheon (RTN), consensus $1.08... Northrop Grumman (NOC), consensus $2.25... Viacom (VIAB), consensus $1.28... Valero Energy (VLO), consensus $1.32... Sherwin-Williams (SHW), consensus $1.38... Hershey (HSY), consensus $1.06... Mead Johnson (MJN), consensus 88c... Zimmer (ZMH), consensus $1.71... Xcel Energy (XEL), consensus 34c... Royal Caribbean (RCL), consensus 42c... Coach (COH), consensus 66c... Kate Spade (KATE), consensus 24c... Harley-Davidson (HOG), consensus 34c... Stanley Black & Decker (SWK), consensus $1.52... L-3 Communications (LLL), consensus $2.27... JetBlue (JBLU), consensus 24c.
11:34 EDTMYL, ABTEC clears Abbott sale of non-U.S. EPD-DM business to Mylan, with conditions
The European Commission has cleared under the EU Merger Regulation the proposed acquisition of Abbott Laboratories' (ABT) Non-U.S. Developed Markets Specialty and Branded Generics Business, or EPD-DM, by Mylan (MYL). The decision is conditional upon the divestment of a number of Mylan's businesses in Germany, the United Kingdom, France, Ireland and Italy. The Commission had concerns that the transaction, as initially notified, would have reduced competition on the market for several medicines. The commitments offered by Mylan address these concerns, the EC said.
January 26, 2015
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.
05:14 EDTSNYRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
January 22, 2015
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
10:16 EDTSNYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
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.

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