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News Breaks
May 8, 2014
06:39 EDTACUR, RBXLY, PFEAcura Pharma announces settlement of patent litigation with Ranbaxy
Acura Pharmaceuticals (ACUR) announced that it has entered into a Settlement Agreement with Ranbaxy (RBXLY) to dismiss, without prejudice, its patent infringement action pending against Ranbaxy in the United States District Court for the District of Delaware. In the suit, Acura alleges that a generic of Acura's AVERSION oxycodone product, previously marketed by Pfizer Inc. (PFE) under its brand name OXECTA, for which Ranbaxy is seeking approval to market in the United States pursuant to an Abbreviated New Drug Application, or ANDA, filing with the FDA infringes U.S. patents owned by Acura. The Settlement Agreement provides that Ranbaxy's current product that is the subject of its ANDA does not infringe Acura's Orange Book listed patents with the FDA. Acura has not provided Ranbaxy with a license to Acura's patents and Acura may re-commence patent infringement litigation against Ranbaxy if Ranbaxy changes the formulation of its generic to the AVERSION oxycodone product.
News For ACUR;RBXLY;PFE 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
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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06:09 EDTACURAcura Pharma reports FDA denies appeal regarding hydrocodone with acetaminophen
Acura Pharmaceuticals announced that the FDA has denied on procedural grounds Acura's appeal of the position taken by Division of Anesthesia, Analgesia, and Addiction Products, or DAAAP, that abuse by snorting of hydrocodone with acetaminophen products lacks relevance. Relevance is defined in FDA's January 2013 Draft Guidance on the evaluation and labeling of abuse deterrent opioids to be a "known or expected" route of abuse for that product. In a letter decision from the Office of Drug Evaluation II, the FDA indicated that DAAAP's comments and correspondence to date with Acura, as well as the Draft Guidance on abuse deterrent opioids, should be viewed only as recommendations and opinions and do not preclude Acura from completing its clinical development and submitting a New Drug Application for its hydrocodone with acetaminophen product for consideration. FDA further noted that for issues such as abuse-deterrence an Advisory Committee meeting may greatly inform their considerations. The FDA's letter also advised the Company that we may appeal this decision to the next level within the FDA. Acura is assessing its development strategy for its abuse deterrent hydrocodone with acetaminophen program, including the merits of appealing the FDA's decision.
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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