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News Breaks
January 14, 2014
05:51 EDTVRX, ACT, MYL, PFEPfizer's generics unit attracts several suitors, Reuters reports
Valeant Pharmaceuticals (VRX), Actavis (ACT) and Mylan (MYL) are each interested in buying Pfizer's (PFE) branded generics business, sources say, even though there are no ongoing discussions at this point, reports Reuters.Reference Link
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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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09:47 EDTVRX, ACTValeant will not raise Allergan bid ahead of record date, CNBC reports
Valeant (VRX) will not raise its hostile takeover bid for Allergan (AGN) ahead of the record date for the vote, CNBC's David Faber reports. Allergan (AGN) is not currently in takeover talks with Actavis (ACT), Faber added.
09:45 EDTACTAllergan not in deal talks with Actavis, CNBC reports
09:43 EDTVRXValeant not going to raise Allergan bid ahead of meeting, CNBC reports
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October 16, 2014
17:27 EDTACTNoven files patent infringement suit against Actavis
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15:10 EDTACTAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.
12:42 EDTVRXAckman believes Allergan, Valeant merger likely, CNBC reports
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12:38 EDTVRXAckman says Allergan CEO manipulated Valeant shares, CNBC reports
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08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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08:08 EDTPFE, ACTActavis confirms generic Quillivant XR patent challenge
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08:02 EDTACTIronwood announces initiation of Phase II linaclotide trial
Ironwood Pharmaceuticals (IRWD) announced the initiation of a Phase II clinical trial evaluating linaclotide for the treatment of adults suffering from opioid-induced constipation. Data are expected in the second half of 2015. The clinical trial is being conducted jointly by Ironwood and Actavis plc (ACT), Ironwood’s co-development and co-promotion partner for linaclotide in the United States. Linaclotide is a guanylate cyclase-C agonist approved by the FDA for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Linaclotide is not currently approved for the treatment of OIC. The randomized, double-blind, placebo-controlled, multi-site Phase II clinical trial is expected to enroll approximately 240 adult patients with chronic, non-cancer pain who have been receiving a stable dose of an opioid analgesic and suffer from constipation, defined as fewer than three spontaneous bowel movements per week. Patients will be randomized to receive 145 mcg of linaclotide, 290 mcg of linaclotide, or placebo for eight weeks. The primary endpoint of the trial is an increase in SBM frequency. Additionally, a number of secondary endpoints and exploratory analyses intended to inform future development plans are included in the study design.
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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13:07 EDTVRXAllergan seeing arb-related selling pressure, says BMO Capital
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October 14, 2014
11:23 EDTPFEBIND Therapeutics and The Conference Forum hold a conference
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07:46 EDTACTActavis should be able to mitigate Irish tax downside, says Leerink
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06:03 EDTACTMarket overreacted to new Irish tax rules, says BMO Capital
BMO Capital believes the market may have overreacted yesterday to the report that Ireland is eliminating the "Double Irish" tax loophole. The firm says Allergan (AGN) confirmed that it incorporated potential changes to Irish tax law in its recently raised earnings guidance while Mallinckrodt (MNK) said it does expect the new tax structure to have an immediate impact. BMO views yesterday's pullback in shares of Allergan, Mallinckrodt and Actavis (ACT) as an overreaction.
October 13, 2014
15:12 EDTACTActavis may see modest negative impact from Irish tax change, says BMO Capital
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08:01 EDTPFEPfizer announces FDA acceptance of Palbociclib NDA with priority review
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