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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Nuevolution discovery platform attracts Amgen deal; $410M per target

Oct. 5, 2016
By Michael Fitzhugh
Amgen Inc. is tapping Nuevolution AB's Chemetics discovery platform to identify multiple small-molecule cancer and neurology candidates for difficult-to-drug targets.
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Merrimack CEO resigns in major restructuring

Oct. 4, 2016
By Michael Fitzhugh
Amid slower-than-anticipated sales of its second-line pancreatic cancer drug Onivyde (irinotecan liposome injection), Merrimack Pharmaceuticals Inc. president and CEO Robert Mulroy resigned and the company moved to cut 22 percent of its work force in a major restructuring it said would prioritize its R&D efforts and eliminate more than $200 million in expected costs over the next two years.
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Threshold Pharma halts tarloxotinib development; sees revival in evo, preclinical TH-3424

Oct. 3, 2016
By Michael Fitzhugh
Threshold Pharmaceuticals Inc. said it would discontinue development of EGFR-targeted tarloxotinib after the oncology candidate fell short of its expectations in dual phase II proof-of-concept trials.
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PCORI backs anticoagulant study, quests for evidence with trust sunset on horizon

Oct. 3, 2016
By Michael Fitzhugh
With nearly 65,000 open studies listed on ClinicalTrials.gov exploring topics from AIDS to Zika, the arrival of better clinical care over time can feel inevitable. Yet, with most trials geared toward showing whether a therapy or device is safe and effective on its own and less so how it stacks up to other options, critical gaps in medical knowledge often remain. Which current treatments work best and for which patients is often unknown.
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Surprise phase III result bonks Intra-Cellular stock

Sep. 30, 2016
By Michael Fitzhugh
An elevated placebo response matching the efficacy of experimental schizophrenia drug ITI-007 in a phase III trial sent shares of its developer, Intra-Cellular Therapies Inc., (NASDAQ:ITCI) down 63.6 percent to close at $15.42 on Thursday.
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Kyprolis fails to extend median PFS in phase III multiple myeloma study

Sep. 28, 2016
By Michael Fitzhugh
Amgen Inc. said a regimen of Kyprolis (carfilzomib), melphalan and prednisone failed to extend median progression-free survival for newly diagnosed multiple myeloma patients beyond what's delivered by a similar regimen anchored instead by Takeda Oncology Co.'s Velcade (bortezomib).
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Investors swoon over Array Biopharma combo results, filing outlook

Sep. 27, 2016
By Michael Fitzhugh
Shares of Array Biopharma Inc. (NASDAQ:ARRY) climbed 81 percent to close at $6.61 on Monday after the Boulder, Colo.-based company announced that the first part of its phase III COLUMBUS trial in BRAF-mutant melanoma met its primary endpoint, a good sign for the company's prospects of engaging with the growing market opportunity represented by MEK /BRAF inhibitors.
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Mast Therapeutic's phase III sickle cell trial EPIC misses endpoint; shares crash

Sep. 22, 2016
By Michael Fitzhugh

Mast Therapeutics Inc. expects to quit development of its lead candidate, vepoloxamer, after it failed to significantly outperform a placebo in shortening the duration of vaso-occlusive crisis (VOC) in the phase III trial EPIC.

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Allergan picks up NASH player Tobira in $1.7B deal; adds Akarna for $50M

Sep. 21, 2016
By Michael Fitzhugh
Allergan plc agreed to pay about $600 million cash and up to $1.1 billion in milestone-based contingent value rights to acquire the non-alcoholic steatohepatitis specialist Tobira Therapeutics Inc. in a deal that adds two complementary candidates, cenicriviroc and evogliptin, to its growing R&D pipeline and heated up competitors' stocks on Tuesday.
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Teva sees pridopidine slowing HD progression in phase II study

Sep. 20, 2016
By Michael Fitzhugh
Teva Pharmaceutical Industries Ltd. reported on Monday that a phase II trial of its experimental Huntington's disease (HD) drug pridopidine showed a statistically significant impact on disease progression at 52 weeks vs. placebo.
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