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News Breaks
February 9, 2014
19:43 EDTBAYRY, PFE, JNJFDA panel recommendation may give boost to Bayer's Aleve, WSJ says
An FDA advisory committee of medical experts will be working this week to determine whether the drug naproxen, sold as Aleve by Bayer (BAYRY ), poses little to no heart danger, says the Wall Street Journal. The advisory committee is evaluating a current labeling requirement that non-steroidal anti-inflammatory drugs, known as NSAIDs, carry a "heart warning", says WSJ, adding that a possible outcome of the review may be"a cleaner label and major marketing advantages for Aleve". Note that Pfizer (PFE) manufactures competing NSAIDs Celebrex and Advil, while Johnson & Johnson, (JNJ) is the maker of of Motrin, also an NSAID. Reference Link
News For BAYRY;PFE;JNJ From The Last 14 Days
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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
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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07:15 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 EDTPFE, BAYRYAmerican 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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October 16, 2014
14:47 EDTJNJRoche in pact with Pharmacyclics to evaluate Imbruvica, Gazyva combo
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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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