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March 3, 2014
07:19 EDTSNY, GILD, ACHN, EBS, BAX, TEVA, AZN, NBS, MNTA, INO, PTLA, ICPT, AMAG, IRWDCowen to host a conference
34th Annual Global Healthcare Conference is being held in Boston on March 3-5 with webcasted company presentations to begin on March 3 at 1:30 pm; not all company presentations may be webcasted. Webcast Link
News For ACHN;ICPT;AZN;GILD;PTLA;TEVA;SNY;INO;BAX;IRWD;MNTA;EBS;AMAG;NBS From The Last 14 Days
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April 8, 2015
14:23 EDTTEVAAdditional bidders for Perrigo could emerge after Mylan offer, says Stifel
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13:07 EDTTEVAMylan bid for Perrigo makes strategic sense, says JPMorgan
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12:37 EDTTEVATeva downgraded to Hold from Buy at Standpoint Research
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11:52 EDTMNTAMomenta downgraded to Neutral from Buy at UBS
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09:20 EDTINOOn The Fly: Pre-market Movers
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08:14 EDTPTLAPortola Pharmaceuticals announces new topline data from ANNEXA-A Phase 3 trial
Portola Pharmaceuticals announced positive topline results from the second part of the Phase 3 ANNEXA-A, or Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors – Apixaban, study, which evaluated the safety and efficacy of andexanet alfa, an investigational antidote, with the Factor Xa inhibitor Eliquis in healthy volunteers. Andexanet alfa, a FDA-designated breakthrough therapy, was administered as an intravenous, or IV, bolus followed by a continuous two-hour infusion to sustain the reversal of anticoagulation activity. This registration-enabling study achieved all primary and secondary endpoints with high statistical significance. Andexanet alfa produced rapid reversal of the anticoagulant effect of apixaban, as measured by anti-Factor Xa activity, which was sustained for the duration of the infusion. In the study, andexanet alfa was well tolerated, with no serious adverse events, thrombotic events, or antibodies to Factor X or Xa reported. The full data from this second part of the ANNEXA-A study will be presented at an upcoming scientific meeting.
07:16 EDTTEVAMylan one of the cheapest names in Specialty Pharma, says JPMorgan
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06:57 EDTICPTIntercept added to short-term buy list at Deutsche Bank
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06:06 EDTINO, AZNInovio selected by DARPA to lead $45M Ebola prevention program
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April 7, 2015
17:58 EDTGILDGilead submits NDA for investigational combination for treatment of HIV-1
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16:12 EDTAZNRegulus up 5% after RG-125 selected as clinical candidate by AstraZeneca
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16:12 EDTAZNRegulus RG-125 selected as clinical candidate by AstraZeneca
Regulus Therapeutics (RGLS) announced the selection of RG-12, a GalNAc-conjugated anti-miR targeting microRNA-103/107, or miR-103/107, for the treatment of Non Alcoholic Steatohepatitis, or NASH, in patients with type 2 diabetes/pre-diabetes, as a clinical candidate by AstraZeneca (AZN) under the companies' strategic alliance to discover, develop and commercialize microRNA therapeutics. RG-125 is the first compound from the alliance to be selected for clinical development by AstraZeneca. In connection with the candidate selection, AstraZeneca will pay Regulus $2.5M and will assume development of the program following acceptance of an Investigational New Drug application. In the near term, Regulus and AstraZeneca plan to submit key preclinical data on the RG-125 program to be presented at a scientific meeting later this year and expect to initiate a Phase I study of RG-125 in humans by the end of 2015.
16:00 EDTGILDOptions Update; April 7, 2015
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15:24 EDTTEVATeva price target raised to $75 from $64 at BMO Capital
BMO Capital raised its EPS estimates for Teva (TEVA) and increased its price target on the stock to $75 from $64 on account of the expected launch of a treatment for chorea associated with Huntington’s disease in 3Q16 and a launch of a tardive dyskinesia drug in 3Q17 following the company's deal to buy Auspex (ASPX). The firm maintains its Outperform rating on Teva shares.
10:38 EDTNBSNeoStem management to meet with Philadelphia Securities Association
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07:14 EDTAZN, SNYEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
April 6, 2015
07:56 EDTACHNAchillion price target lowered to $20 from $25 at Deutsche Bank
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07:36 EDTGILDGilead Q1 HCV revenue poised to beat expectations, says RBC Capital
After analyzing weekly prescription data, RBC Capital believes that Gilead's weekly hepatitis C prescriptions are tracking towards $3.5B-$3.6B of revenue from hepatitis C drugs for Q1, versus the consensus outlook of about $2.6B. The firm keeps an Outperform rating on Gilead.
05:56 EDTTEVATeva battles possible generic Copaxone competitors, Globes reports
A citizen's petition has been filed by Teva with the FDA against possible generic competition to its MS treatment Copaxone beginning in September, Globes reports. The FDA has previously ruled that it was "too early" to discuss the matter. Reference Link
April 5, 2015
14:43 EDTGILDActavis seeks FDA approval to market generic version of Gilead's Letairis
Actavis (ACT) on Friday, confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Ambrisentan Tablets, 5 mg and 10 mg. Actavis' ANDA product is a generic version of Gilead Science's (GILD) Letairis, which is a treatment for pulmonary arterial hypertension. Gilead Sciences and Royalty Pharma Collection Trust filed suit against Actavis on April 1, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of U.S. Patent number RE42,462. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities. Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Letairis and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity. For the 12 months ending December 31, Letairis had global sales of approximately $595M, according to Gilead.
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