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Stock Market & Financial Investment News

News Breaks
May 30, 2014
12:47 EDTMYL, PFEMylan sees 'imminently' receiving final approval on 50 mg generic Celebrex
Mylan (MYL) commented on the decision by the U.S. District Court for the Northern District of West Virginia denying Mylan's request for an injunction in its suit against the FDA, challenging the agency's decision regarding generic drug marketing exclusivity on Celecoxib Capsules, the generic version of Pfizer's (PFE) Celebrex. Mylan said it continues to believe that FDA "seriously erred" in its decision regarding eligibility for 180 days of exclusivity on Celecoxib. "Mylan will review all of its options, including filing an expedited appeal in the United States Court of Appeals for the Fourth Circuit," the company said. Mylan expects to receive final approval on the 50 mg strength of Celecoxib capsules "imminently" and has received tentative approval from FDA on all Celecoxib strengths, the company said.
News For MYL;PFE From The Last 14 Days
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October 23, 2014
06:22 EDTMYLMylan, Abbott enter into amendment, still see deal closing in 1Q15
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October 22, 2014
11:59 EDTMYLStocks with call strike movement; MYL AMZN
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09:16 EDTMYLAbbott sees Q4 reported sales growth in high single digits
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October 21, 2014
07:15 EDTPFEFDA to hold workshop on breast cancer drug development
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07:06 EDTPFEFierce Biotech to hold a breakfast meeting
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October 20, 2014
08:04 EDTMYLGerman fund pressured to sell Mylan stake over drug used in executions, FT says
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07:47 EDTPFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:20 EDTMYLInternational Continence Society to hold annual meeting
ICS Annual Meeting 2014 is being held in Rio de Janeiro, Brazil on October 20-24.
07:15 EDTPFEAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
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07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
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07:11 EDTPFEAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFEAmerican Society of Human Genetics to hold annual meeting
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October 17, 2014
16:41 EDTPFEPfizer confirms FDA labeling approval for EMBEDA capsules
Pfizer announced that the FDA has approved an updated label for EMBEDA extended-release capsules, for oral use to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous, or IV, morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.
16:30 EDTPFEFDA approves new labeling from Embeda extended-release capsules
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October 16, 2014
08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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08:08 EDTPFEActavis confirms generic Quillivant XR patent challenge
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07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
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October 15, 2014
15:00 EDTPFEShire-Allergan, AbbVie-Pfizer deals possible if merger scrapped, Bloomberg says
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October 14, 2014
11:23 EDTPFEBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
08:01 EDTPFEPfizer announces FDA acceptance of Palbociclib NDA with priority review
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