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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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August 18, 2014
08:01 EDTPFEPfizer announces submission of Palbociclib NDA to FDA
Pfizer announced it has completed the submission of a New Drug Application to the United States Food and Drug Administration for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
07:57 EDTPFECambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 14, 2014
17:05 EDTPFEPfizer says FDA accepted for review BLA for bivalent recombinant LP2086
Pfizer announced that the FDA has accepted for review the Biologics License Application,BLA, for bivalent recombinant LP2086, the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. The FDA has also granted Priority Review designation for the BLA, providing an anticipated Prescription Drug User Fee Act, PDUFA, action date of February 14, 2015. “Pfizer has closely collaborated with the FDA since 2008 to develop our meningococcal B vaccine candidate with the intent to help prevent this devastating disease,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer. “Both the acceptance of Pfizer’s Biologics License Application today, and its Priority Review designation, are significant regulatory milestones that underscore the importance of our efforts to expedite the approval and subsequent availability of our meningococcal B vaccine for U.S. adolescents.”
August 12, 2014
17:07 EDTPFEPfizer announces results from Lyrica studies conducted in China
Pfizer announced top-line results from two placebo-controlled studies conducted in China with Lyrica in patients with postherpetic neuralgia, pain after shingles or PHN, and painful diabetic peripheral neuropathy, pDPN, respectively.The PHN Phase 4 study, A0081276, met its primary endpoint by demonstrating a statistically significant reduction in pain when compared to placebo. Separately, the pDPN Phase 3 study, A0081265, did not meet its primary endpoint, a statistically significant change in endpoint mean pain score relative to placebo. The PHN study was an eight-week, randomized, double-blind, multi-center, placebo-controlled, post-marketing study evaluating the efficacy, safety and tolerability of pregabalin 300mg/day in the treatment of subjects with PHN. For the primary efficacy parameter, change from baseline in weekly mean pain scores, a significant treatment difference of -0.71 points for pregabalin relative to placebo was observed. The safety profile in this study was consistent with the known profile for Lyrica.
August 11, 2014
07:36 EDTMYLMylan launches generic Xeloda tablets
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August 8, 2014
17:10 EDTMYLMarket finishes week up slightly as earnings offset by political events
Stocks finished the week fractionally higher than where they started as strong corporate earnings reports and better than expected economic data was weighed against concerns about geopolitical issues and negative M&A news. MACRO NEWS: A few ongoing geopolitical conflicts worried investors and weighed on shares. Russia unveiled sanctions against Western countries, banning the import of a wide range of food items from the U.S, the EU and a few allied countries in response to sanctions recently enacted against it from G7 nations... President Obama authorized the bombing of rebels in Iraq and Hamas and Israel failed to reach a permanent truce... An ISM services index, the U.S. trade deficit for June, and weekly jobless claims were all better than expected. Meanwhile, the increase in unit labor costs last quarter came in below the consensus outlook, perhaps easing fears that the Fed will need to raise interest rates sooner than expected. COMPANY NEWS: On the M&A front, two huge potential deals fell through as 21st Century Fox (FOX, FOXA) withdrew its offer to acquire Time Warner (TWX) and Sprint (S) reportedly decided to end its pursuit of a merger with peer T-Mobile (TMUS)... President Obama indicated that his administration would take unilateral steps in an effort to prevent companies from carrying out tax inversion acquisitions. Among the deals or possible transactions that involve inversion are Medtronic's (MDT) acquisition of Covidien (COV), Valeant's (VRX) proposed takeover of Allergan (AGN) and Mylan's (MYL) acquisition of Abbott's (ABT) developed markets branded generics pharmaceuticals business. Meanwhile, Walgreen's (WAG) stock tumbled after the U.S. company said it would not structure its takeover of European drugstore chain Alliance Boots as a tax inversion deal... 21st Century Fox, 3D printer maker Stratasys (SSYS), chip maker NVIDIA (NVDA), brewer Molson Coors (TAP), and luxury accessories maker Coach (COH) all rose following their earnings reports. Conversely, Target (TGT), luxury accessories maker Michael Kors (KORS) and Internet coupon provider Groupon (GRPN) fell following their results or guidance... Gannett (GCI) struck a deal to acquire the remaining 73% interest in Classified Ventures, whose primary asset is the online car shopping website Cars.com, for $1.8B from the other partners in the venture, which include McClatchy (MNI), Tribune Media (TRBAA), Graham Holdings (GHC) and A. H. Belo (AHC). Gannett also announced plans to spin-off its Publishing business, which includes USA Today, through a tax-free distribution to shareholders... McDonald's (MCD) stock was little changed after the company reported that its comparable store sales fell 2.5% in July, which was significantly worse than expected. Food quality issues weighed on the fast food company's sales in Asia and as a result of the China supplier issue, the company warned its previously issued global comparable sales forecast for 2014 is now at risk. INDEXES: The Dow finished the week up 0.35% to 16,553.93, the S&P 500 rose 0.32% to 1,931.59, and the Nasdaq gained 0.41% to 4,370.90.
12:34 EDTMYLOn The Fly: Midday Wrap
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10:00 EDTMYLOn The Fly: Analyst Downgrade Summary
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07:01 EDTMYLHarvard professor says Treasury can reduce inversion incentives, NY Times says
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06:39 EDTPFEPfizer faces torrent of Lipitor suits, Reuters says
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06:30 EDTMYLMylan downgraded to Sector Perform from Outperform at RBC Capital
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August 7, 2014
10:29 EDTMYLMylan: Noise about inversion is tremendous speculation and that's all it is
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10:23 EDTMYLMylan sees FY14 CapEx $350M-$400M
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10:20 EDTMYLMylan sees FY14 adjusted EBITDA $2.2B-$2.4B
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10:20 EDTMYLMylan says litigation ins ongoing in India regarding Teva
Mylan (MYL) said that it expects Teva's (TEVA) efforts to seek an injunction will "as ineffective as it was in U.S. courts." The company said it will not provide further comment on the matter. Mylan said it will also postpone its 2014 Investor Day due to the ongoing nature of the Abbott (ABT) transaction. It expects its fully realized savings and profit from new products will not be realized till 2015. Comments taken from Q2 earnings conference call.
08:12 EDTPFEPfizer says EMA accpets application seeking new indication for Prevenar 13
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06:42 EDTMYLObama to look to limit inversion deals, Politico says
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06:37 EDTMYLMylan narrows FY14 adjusted EPS view to $3.25-$3.45 from $3.25-$3.60
Consensus $3.37. Narrows FY14 revenue guidance to $7.8B-$8B from $7.8B-$8.2B, consensus $7.77B.
06:36 EDTMYLMylan sees Q3 EPS 90c-95c, consensus $1.03
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06:34 EDTMYLMylan reports Q2 adjusted EPS 69c, consensus 70c
Reports Q2 revenue $1.84B, consensus $1.88B.
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