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March 4, 2013
33rd Annual Health Care Conference is being held in Boston on March 4-6 with webcasted company presentations to begin on March 4 at 1:30 pm; not all company presentations may be webcasted. Webcast Link
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November 11, 2014
11:35 EDTGILDUBS holds a conference call with Gilead Sciences
UBS Biotech Analyst Roden, along with Dr. Bischofberger of Gilead Sciences, discuss the recently-held AASLD Meeting and the outlook of several GILD pipeline programs on a conference call to be held on November 13 at 4:30 pm.
10:14 EDTSNYRegeneron data reinforce blockbuster potential of dupilumab, says Piper Jaffray
Piper Jaffray believes the Phase IIb results for dupilumab in patients with moderate to severe asthma reported by Regeneron (REGN) and partner Sanofi (SNY) reinforce the broad potential of the drug in a range of allergic diseases. The firm reiterates its $416 price target and Overweight rating on shares of Regeneron.
09:13 EDTACADACADIA NDA filing delay minor, says JMP Securities
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08:07 EDTGILDGilead announces results from Phase 2 and 3 studies evaluating Harvoni
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08:05 EDTGILDGilead announces data from Phase 2 Sofosbuvir plus GS-5816 studies
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07:13 EDTACADACADIA filing delay does not impact price target, says Piper Jaffray
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07:07 EDTTHLDThreshold Pharmaceuticals receives FDA fast track designation for TH-302
Threshold Pharmaceuticals announced that the FDA granted Fast Track designation for TH-302, an investigational anticancer drug, for the treatment of previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma, or STS. The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. An important feature of Fast Track is that the FDA may consider a "rolling review" of completed sections of the New Drug Application before the complete application is submitted.
05:26 EDTSNYRegeneron, Sanofi announce dupilumab Phase 2b study met primary endpoint
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November 10, 2014
18:32 EDTACADOn The Fly: After Hours Movers
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16:05 EDTACADACADIA delays NUPLAZID application to Q1 of 2015
ACADIA said it plans to submit its NUPLAZID NDA for Parkinson's disease psychosis in Q1 of 2015. The company had previously planned to submit the NDA near the end of 2014. It stated, "The decision to move back the planned submission is based on additional time required to complete preparations needed to support the U.S. Food and Drug Administrationís, review of NUPLAZID. The change in submission timing is not a result of any change to NUPLAZIDís clinical or safety profile, nor is it a result of any interaction with or request for information from the FDA. Additionally, ACADIA reported that it has successfully completed its drug-drug interaction program and its registration stability program."
16:04 EDTACADACADIA reports Q3 EPS (25c), consensus (22c)
At September 30, 2014, ACADIAís cash, cash equivalents, and investment securities totaled $337.8M.
16:00 EDTGILDOptions Update; November 10, 2014
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15:54 EDTSNY, ALXNAmerican Society of Nephrology to hold a conference
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15:26 EDTACADNotable companies reporting after market close
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09:35 EDTGILDActive equity options trading
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09:20 EDTGILDOn The Fly: Pre-market Movers
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09:20 EDTALXNJPMorgan biotech analyst to hold an analyst/industry conference call
U.S. SMid Biotech Analyst Rama, along with Key Opinion Leader Dr. Hickman Simmons from Vanderbilt University, discuss Alexion Pharmaceuticals' Asfotase Alfa and Hypophosophatasia on an Analyst/Industry conference call to be held on November 11 at 11 am.
08:48 EDTGILDGilead rises after Merck presents data on HCV combo
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07:20 EDTGILDGilead overhang from Merck HCV combo removed, says Wells Fargo
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06:31 EDTALXNAlexion announces planned retirement of co-founder, COO Stephen Squinto
Alexion announced the planned retirement of company co-founder Stephen Squinto, effective January 1, 2015. Squinto currently serves as Executive Vice President, Chief Global Operations Officer. He co-founded Alexion in 1992 with Leonard Bell, M.D., the Companyís principal founder and current Chairman and Chief Executive Officer.
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