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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Payoff: Pfizer licenses Opko's long-acting human growth hormone

Dec. 16, 2014
By Michael Fitzhugh
Opko Health Inc.'s $540.6 million all-stock acquisition of Prolor Biotech Inc. paid off Monday as Pfizer Inc. grabbed an exclusive license to the Prolor-developed long-acting human growth hormone (hGH) for $295 million up front, plus up to $275 million in regulatory milestones.
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Alnylam begins phase III study of revusiran for rare genetic disease FAC

Dec. 15, 2014
By Michael Fitzhugh
Alnylam Pharmaceuticals Inc. has begun enrolling patients for a phase III study of one of its most advanced experimental RNAi therapies, revusiran, a treatment for transthyretin (TTR)-mediated familial amyloidotic cardiomyopathy, a manifestation of TTR-mediated amyloidosis that afflicts about 40,000 people worldwide.
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Antidotes for new anticoagulants nearing market; move over, warfarin

Dec. 15, 2014
By Michael Fitzhugh
With the relatively recent arrival of new oral anticoagulants (NOACs) vying to displace warfarin with the promise of fewer side effects, easier dosing and less need for regular monitoring, patients and their doctors have gained valuable new tools to reduce the risks of blood clots.
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Osteoqc mines Canadian talent to build new bone disease venture

Dec. 12, 2014
By Michael Fitzhugh
Osteoqc Inc., a new Montreal-based company that will develop therapies for the treatment of bone-related diseases, is leveraging a portfolio of candidates for promoting bone growth developed by Overland Park, Kan.-based Osteogenex Inc. to build a new venture.
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Bluebird early gene therapy data brighten horizon for beta-thalassemia patients

Dec. 10, 2014
By Michael Fitzhugh
SAN FRANCISCO – Bluebird Bio Inc. reported that four young adults with beta-thalassemia major, a severe blood disorder that leads to life-threatening anemia, were able to produce sufficient hemoglobin to reduce or eliminate the need for chronic blood transfusions after being treated with its gene therapy, Lentiglobin BB305.
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Checkpoint inhibitors get an upper hand on lymphoma

Dec. 9, 2014
By Michael Fitzhugh
SAN FRANCISCO ­– Data from Bristol-Myers Squibb Co. and Merck & Co. Inc. reported at the 56th Annual American Society of Hematology suggest that their PD-1 immunotherapies, Opdivo (nivolumab) and Keytruda (pembrolizumab) respectively, may prove to be powerful tools against lymphomas.
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FDA approves Incyte's Jakafi for uncontrolled PV

Dec. 8, 2014
By Michael Fitzhugh
Incyte Corp. has become the first company to win FDA approval for a treatment targeting uncontrolled cases of the rare chronic bone marrow cancer polycythemia vera (PV), which sometimes advances to myelofibrosis.
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Array gains $85M as Novartis returns binimetinib rights

Dec. 5, 2014
By Michael Fitzhugh
Array Biopharma Inc. shares (NASDAQ:ARRY) climbed 14.3 percent to $4.47 Thursday as Novartis AG returned full rights to the phase III MEK inhibitor, binimetinib, pledging up to $85 million plus significant follow-on support for Array’s plans to seek approval for using the drug to treat NRAS-mutant melanoma during the first half of 2016.
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Naurex raises $80M to knock out depression

Dec. 4, 2014
By Michael Fitzhugh
Naurex Inc. raised an $80 million series C to carry its fast-acting experimental depression therapy, the NMDA receptor modulator GLYX-13, into its first phase III study in mid-2015.
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Negotiating a place for race in the age of personalized medicine

Dec. 3, 2014
By Michael Fitzhugh
Despite known racial and ethnic differences in patient response to certain drugs, the incorporation of those factors into the construction and execution of global clinical trials remains as complex and controversial as ever.
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