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News Breaks
July 1, 2014
09:05 EDTGLYC, PFEGlycoMimetics announces agreement with FDA for rivipansel
GlycoMimetics (GLYC) announced today that Pfizer (PFE) has reached agreement with the U.S. Food & Drug Administration under a special protocol assessment for a Phase 3 trial for rivipansel. A SPA is a written agreement between a trialís sponsor and the FDA regarding the design, endpoints and statistical analysis approach of a Phase 3 clinical trial, results from which could potentially support approval of a New Drug Application. Rivipansel is being developed as a potential therapy for treatment of patients with sickle cell disease who are hospitalized for vaso-occlusive crisis. Rivipansel has previously received both Orphan Drug and Fast Track status for the treatment of VOC from the FDA. Pfizer plans to begin the Phase 3 program before the end of 2014.
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October 23, 2014
18:18 EDTPFEGlenview Capital acquires stake in Actavis, Bloomberg reports
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16:17 EDTPFEPfizer announces new $11B share repurchase program
The board of directors also authorized a new $11B share repurchase program to be utilized over time. This new program is in addition to the $1.3B of authorization remaining under the companyís current share repurchase program.
08:15 EDTPFEPfizer wins SUTENT patent case In Delaware District Court
Pfizer (PFE) announced today that the U.S. District Court for the District of Delaware upheld its basic patent and the L-malate salt patent covering SUTENT capsules. This decision, which is subject to appeal, affirms Pfizerís right to exclusively provide sunitinib malate as SUTENT to patients through the term of the patent, which expires in 2021. Pfizer filed suit in June 2010 after Mylan (MYL) applied to the U.S. Food and Drug Administration to market a generic version of SUTENT prior to the expiration of the patents covering sunitinib malate and its uses. After a four-day trial, the Court agreed that Mylan infringed the valid patents covering SUTENT.
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
11:13 EDTGLYCGlycoMimetics management to meet with Maxim
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07:47 EDTPFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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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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October 10, 2014
08:06 EDTPFEPfizer presents Staphylococcus aureus vaccine Phase 1, Phase 2 study data
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