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News Breaks
April 10, 2014
06:17 EDTACUR, PFEAcura Pharma announces return of product rights from Pfizer
Acura Pharmaceuticals (ACUR) announced a letter agreement with Pfizer (PFE) providing for the termination of Pfizer's license to Acura's AVERSION Technology and the return to Acura of the FDA approved Oxecta product. The letter agreement provides that Acura will make a one-time payment of $2M to Pfizer. The license termination is effective April 9. The AVERSION Technology utilizes a proprietary mixture of inactive ingredients to discourage tampering of a product for abusive purposes.
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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 company’s 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 Pfizer’s 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
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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