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Stock Market & Financial Investment News

News Breaks
June 2, 2014
07:03 EDTMYL, PFEMylan settles patent litigation related to Celebrex capsules with Pfizer
Mylan (MYL) announced that it has entered into a settlement and license agreement with Pfizer (PFE) relating to Mylan's Abbreviated New Drug Application filed with the FDA for Celecoxib Capsules, 50 mg, 100 mg, 200 mg and 400 mg. This product is the generic version of Celebrex, which is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Under the terms of the agreement, Mylan will begin selling product at the earliest market formation, however in any case not later than December. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. Additionally, Mylan has appealed the decision by the United States District Court for the Northern District of West Virginia denying Mylan's request for an injunction in its suit against the FDA. Mylan continues to believe that FDA seriously erred in its decision awarding one party eligibility for 180 days of exclusivity on Celecoxib, and will continue with this suit independent of the aforementioned settlement.
News For MYL;PFE From The Last 14 Days
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August 29, 2014
10:17 EDTPFEInnoPharma announces FDA approval of generic Dacogen
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August 28, 2014
13:17 EDTPFEPfizer, Protalix announce FDA approves ELELYSO pediatric indication
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11:22 EDTMYLMylan ANDA for three times per week generic Copaxone accepted by FDA for filing
Mylan (MYL) announced that its abbreviated new drug application for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration. This product is the generic version of Teva's (TEVA) Copaxone 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Copaxone 40 mg/mL had U.S. sales of approximately $411.5M for the 12 months ending June 30, 2014, according to IMS Health.
08:55 EDTPFEOn The Fly: Pre-market Movers
HIGHER: Digital Ally (DGLY), up 16% after announcing order from Michigan State Police for over $1.1M... EnteroMedics (ETRM), up 12.4% after reporting three-year data from Maestro RC system... Repros (RPRX), up 0.8% after Androxal achieves superiority in both co-primary endpoints in a study... Synthetic Biologics (SYN), up 2.7% after Pfizer (PFE) was granted FDA Fast Track designation for its investigational Clostridium difficile vaccine candidate. Synthetic Biologics announced earlier this week that SYN-004, the company's lead anti-infective product candidate for the prevention of the effects of C. difficile, will be presented in October... Signet (SIG), up 3.9% after Q2 revenue tops consensus. DOWN AFTER EARNINGS: Abercrombie & Fitch (ANF), down 5.7%... Guess (GES), down 8.3%... Frontline (FRO), down 7%. ALSO LOWER: Williams-Sonoma (WSM), down 10.9% after downgraded at Morgan Stanley following the company's Q2 earnings report... GT Advanced (GTAT), down 2% after downgraded at Raymond James... Sungy Mobile (GOMO), down 20.1% following earnings report, CFO resignation, downgrade of stock at Oppenheimer... Genesco (GCO), down 7.7% after cutting fiscal year forecast.
08:01 EDTPFEPfizer says FDA grants fast track designation to C-difficile vaccine candidate
Pfizer announced that the U.S. Food and Drug Administration thas granted Fast Track designation to the company’s investigational Clostridium difficile vaccine candidate PF-06425090. Currently in Phase 2 clinical development, the vaccine candidate is designed to prevent C. difficile-associated disease, which can include life-threatening diarrhea and pseudomembranous colitis. The FDA’s Fast Track approach is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address an unmet medical need.
August 27, 2014
09:53 EDTPFEOn The Fly: Analyst Initiation Summary
Bristol-Myers (BMY) initiated with a Hold at Deutsche Bank... ASML (ASML) initiated with a Hold at Stifel... Akamai (AKAM) initiated with an Outperform at RW Baird... Concur (CNQR) initiated with a Neutral at DA Davidson... CyrusOne (CONE) initiated with a Neutral at Citigroup... Eli Lilly (LLY) initiated with a Buy at Deutsche Bank... Garmin (GRMN) initiated with a Neutral at RW Baird... Merck (MRK) initiated with a Hold at Deutsche Bank... NetSuite (N) initiated with a Buy at DA Davidson... Oracle (ORCL) initiated with a Neutral at DA Davidson... Oxford Industries (OXM) initiated with a Buy at Wunderlich... Pfizer (PFE) initiated with a Buy at Deutsche Bank... ServiceNow (NOW) initiated with a Buy at DA Davidson... Workday (WDAY) initiated with a Neutral at DA Davidson... MannKind (MNKD) initiated with a Buy at Jefferies... STMicroelectronics (STM) initiated with an Underperform at Credit Suisse... Kirkland's (KIRK) initiated with an Outperform at Barrington.
06:42 EDTPFEPfizer initiated with a Buy at Deutsche Bank
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August 26, 2014
08:01 EDTPFEPfizer, Merck to collaborate on study evaluating anti-cancer combination regimen
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August 25, 2014
06:29 EDTPFEPfizer mulls possible AstraZeneca offer options, FT says
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August 22, 2014
14:19 EDTPFEViiV Healthcare receives FDA approval for HIV-1 treatment Triumeq
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08:02 EDTMYLMylan launches first generic Klor-Con Extended-release tablets
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August 21, 2014
13:32 EDTPFEBristol-Myers, Pfizer announce approval of Eliquis for treatment of DVT, PE
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09:54 EDTPFEPotential Pfizer, AstraZeneca deal seen around year-end, Reuters says
Investors and analysts see Pfizer (PFE) making another attempt to acquire AstraZeneca (AZN) around year-end, even though talks between the two can resume on August 26 per British takeover rules, Reuters reports. Reference Link
08:02 EDTPFEPfizer initiates U.S. EAP for palbociclib.
Pfizer announced that the company has initiated a multi-center, open-label expanded access program in the U.S. for palbociclib. Through the program, palbociclib is being made available for use in combination with letrozole for post-menopausal women with hormone receptor positive human epidermal growth factor receptor 2 negative advanced breast cancer for whom letrozole is considered appropriate therapy.
07:55 EDTPFEActavis volatility expected to move on Pfizer considering new target report
Actavis (ACT) volatility is expected to move on Pfizer (PFE) considering other overseas alternatives, Bloomberg reports. Overall option implied volatility of 27 is near its 26-week average of 31 according to Track Data, suggesting decreasing price movement.
07:47 EDTPFEPfizer looking at new targets, including Actavis, Bloomberg reports
While it weighs another attempt to acquire AstraZeneca (AZN), Pfizer is considering other overseas alternatives, including Actavis (ACT), Bloomberg reports, citing people familiar with the matter. Pfizer prefers to reach a deal with AstraZeneca, and a move on another company is unlikely "anytime soon," Bloomberg adds, citing its sources. Shares of Actavis are rising 3%, or $6.65, to $230.01 in pre-market trading, while AstraZeneca is up 2% to $72.59. Reference Link
August 20, 2014
11:44 EDTMYLMylan completes second bidding round for GSK prescription portfolio, WSJ says
Mylan (MYL), TPG Capital, Advent International, KKR (KKR), Warburg Pincus and a few Indian prescription manufacturers have completed the second round of bidding for GlaxoSmith Kline's (GSK) portfolio of mature medications, according to The Wall Street Journal, citing people familiar with the sales process. GSK noted that it aims to sell a portfolio of drug brands in the U.S. and EU with yearly sales of approximately $1.66B. Reference Link
11:33 EDTMYLMylan into second round of bidding for GSK drug portfolio, WSJ reports
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08:03 EDTPFEBristol-Myers Pfizer to present new Eliquis data
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August 19, 2014
11:44 EDTMYLMylan launches generic Precedex Injection
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