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News Breaks
June 12, 2014
07:44 EDTSLXP, NKTR, PGNX, AZNFDA Anesthetic & Analgesic Drug Products Advisory Committee holds a meeting
The Committee reviews opioid antagonists being developed for opioid induced constipation including Progenics' and Salix Pharmaceuticals' Subcutaneous RELISTOR and Nektar Therapeutics and AstraZeneca's Naloxegol in a meeting being held at FDA Silver Spring, Maryland offices on June 12 at 8 am. Webcast Link
News For AZN;NKTR;SLXP;PGNX From The Last 14 Days
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December 16, 2014
09:16 EDTSLXPOn The Fly: Pre-market Movers
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07:07 EDTSLXPSalix expects to achieve wholesale inventory targets by year-end 2015
07:07 EDTSLXPSalix sees FY16 EPS $8.50-$9.50
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07:06 EDTSLXPSalix sees FY15 EPS $3.10-$4.10, consensus $4.49
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07:04 EDTSLXPSalix says FDA extends PDUFA data for Xifaxan 550 to May 27, 2015
Salix announced that on December 15, 2014, the FDA provided written notice to the company that it has extended the Prescription Drug User Fee Act Action Date for XIFAXAN 550 for the treatment of irritable bowel syndrome with diarrhea, or IBS-D, to May 27, 2015. The company remains confident that FDA approval for XIFAXAN 550 for the treatment of IBS-D will be obtained, and it maintains its previously-announced peak year sales estimate for this product of approximately $2.1B. However, there is no assurance that FDA approval will be obtained in a timely manner or at all.
07:03 EDTSLXPSalix accelerating reduction of wholesale inventory levels of Xifaxan 550
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07:02 EDTSLXPSalix withdraws previously issued guidance for Q4, FY14
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December 15, 2014
07:33 EDTAZNAdvaxis announces FDA acceptance of INDA to commence clinical trials of ADXS-HPV
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December 11, 2014
18:03 EDTNKTRNektar reports data from Phase 3 BEACON study of NKTR-102
Nektar Therapeutics presented biomarker data from a sub-study of the Phase 3 BEACON study of etirinotecan pegol (NKTR-102) which collected and analyzed circulating tumor cell samples from patients in the study. A total of 80% of the 852 patients enrolled in the BEACON trial participated in the CTC sub-study. Among the 627 patients who participated and had evaluable baseline samples, CTCs were detected in 97% of these samples. For the 611 evaluable baseline patient samples which yielded CTCs, potential NKTR-102 target-specific pharmacodynamic biomarkers were detected in the majority of samples. The pharmacodynamic biomarkers assessed in the CTC sub-study were chosen because of their potential ability to predict response to topoisomerase inhibition as well as to measure chemo-sensitivity in metastatic cancer patients
16:03 EDTAZNAmgen, AstraZeneca to present results from Phase 3 plaque psoriasis study
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08:05 EDTNKTRFDA Pediatric Oncologic Subcommittee to hold a meeting
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07:28 EDTAZNCBI to hold a summit
2nd Specialty Data Optimization Summit is being held in Philadelphia on December 11.
December 10, 2014
13:59 EDTSLXPSalix shares defended at Sterne Agee
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December 9, 2014
09:10 EDTAZNARIAD takeover rumors rekindled, Independent says
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08:02 EDTAZN, NKTRMoventig approved in EU for opioid-induced constipation
Nektar (NKTR) reported partner AstraZeneca (AZN) announced that MOVENTIG has been granted Marketing Authorisation by the European Commission for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxative. MOVENTIG is the first once-daily oral peripherally-acting mu-opioid receptor antagonist to be approved in the European Union.
07:44 EDTNKTR, AZNAmerican Association for Cancer Research to hold a symposium
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December 8, 2014
07:29 EDTNKTRUBS to hold investor trip
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07:18 EDTNKTRUBS to hold investor trip
2014 Annual West Coast Investor Trip travels on the West Coast on December 8-10.
07:05 EDTAZNInnocoll appoints Tony Zook as CEO
Innocoll AG (INNL) announced that Tony Zook, formerly executive vice president, Global Commercial Operations, at AstraZeneca (AZN), has been appointed CEO effectively immediately. Michael Myers, will continue with the company as head of Portfolio Operations.
December 5, 2014
09:49 EDTAZNUBS European pharmaceuticals analysts holds analyst/industry conference call
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