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News Breaks
December 19, 2012
17:54 EDTBMY, PFE, JNJFDA says Pradaxa not safe for use on patients with mechanical heart valves
The U.S. Food and Drug Administration ,FDA, is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial)1 was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users. Boehringer Ingelheim's is the manufacturerof Pradaxa. Note that Pradaxa competitors include: Eliquis, from Bristol-Myers Squibb (BMY) and Pfizer (PFE), Xarelto from Johnson & Johnson (JNJ) and Coumadin, an older drug from from Bristol-Myers Squibb.
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October 23, 2014
05:58 EDTJNJStocks with implied volatility below IV index mean; XLNX JNJ
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October 22, 2014
17:50 EDTJNJBavarian Nordic announces expanded collaboration with Janssen on MVA-BN
Bavarian Nordic A/S announced that it has agreed with Crucell Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ), to expand the collaboration announced earlier to include evaluation of Bavarian Nordic's proprietary vaccine platform technology, MVA-BN, for additional undisclosed disease targets. Bavarian Nordic and Janssen will collaborate on the evaluation of MVA-BN for three additional infectious disease targets. Janssen is granted the exclusive option to collaborate on one or more of the targets, following scientific evaluation of MVA-BN-based vaccine candidates, which will be developed by Bavarian Nordic.
05:31 EDTJNJJohnson & Johnson announces commitment to speed Ebola vaccine development
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October 21, 2014
07:15 EDTPFE, BMYFDA 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
12:36 EDTJNJOptions with decreasing implied volatility
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08:14 EDTJNJPharmacyclics files supplmeental NDA for Imbruvica for macroglobulinemia
Pharmacyclics (PCYC) announced that it has submitted a supplemental New Drug Application to the FDA based on data from a Phase 2 study evaluating the use of IMBRUVICA in patients with Waldenstrom's macroglobulinemia. IMBRUVICA, which received FDA Breakthrough Therapy Designation in February 2013 for patients with WM, is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech (JNJ).
07:47 EDTPFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:19 EDTBMYIBC Life Sciences to hold a conference
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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
16:55 EDTJNJStocks end volatile week lower amid oil price plunge
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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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10:37 EDTJNJOptions with decreasing implied volatility: ATLS JNJ XLNX JNK HYG
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08:57 EDTJNJPharmacyclics price target raised to $188 from $185 at Roth Capital
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08:51 EDTJNJPharmacyclics announces European approval for Imbruvica
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08:02 EDTJNJCovidien granted preliminary injunction against Ethicon's Harmonic ACE+7
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