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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Biogen cues phase III Alzheimer's study on promising phase Ib data

Dec. 3, 2014
By Michael Fitzhugh
Biogen Idec Inc. shares (NASDAQ:BIIB) rose a healthy 6.4 percent, or $19.83, to $328.27 Tuesday as investors swooned over news the company is aggressively advancing plans for a phase III study of its experimental Alzheimer's disease (AD) drug, BIIB037, also known as aducanumab.
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Intra-Cellular trials lead antipsychotic in first phase III

Nov. 26, 2014
By Michael Fitzhugh
Intra-Cellular Therapies Inc. enrolled the first patient in one of two planned phase III studies of its lead candidate for the treatment of acutely exacerbated schizophrenia, triggering a $1.5 million obligation to IP partner Bristol-Myers Squibb Co. and positioning itself to deliver the first late-stage results for the drug, called ITI-007, as early as next year's fourth quarter.
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Merck takes $50M license on Newlink Ebola vaccine

Nov. 25, 2014
By Michael Fitzhugh
Merck & Co. Inc. licensed global R&D and manufacturing rights for Newlink Genetics Corp.'s phase I Ebola vaccine, agreeing to pay the immunotherapy developer $30 million up front, plus $20 million more once efficacy testing begins early next year.
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Corbus prepares to put anti-inflammatory drug to the test

Nov. 24, 2014
By Michael Fitzhugh
Just six months after revealing a $10.3 million private placement to back development of a once-shelved therapy, Corbus Pharmaceuticals Holdings Inc. is preparing to submit an investigational new drug application to jump straight into a phase IIa trial of its sole program, an anti-inflammatory therapy it calls Resunab.
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Novartis, Atlas fund CRISPR-Cas9 venture Intellia in $15M series A

Nov. 19, 2014
By Michael Fitzhugh
Intellia Therapeutics Inc., a new company formed to develop CRISPR-Cas9 therapeutics for gene editing and repair, closed a $15 million series A round led by Atlas Venture and Novartis Institutes for Biomedical Research.
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After Lemtrada approval, biosimilar competitors lie in wait

Nov. 18, 2014
By Michael Fitzhugh
The FDA's approval of Genzyme Corp.'s Lemtrada (alemtuzumab) for relapsing forms of multiple sclerosis (MS) Friday brought good news for patients who've had trouble with other therapies, not to mention its parent company, Sanofi SA, which received a complete response letter last year questioning the drug's benefits in light of its risks.
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'New chapter' as Geron lands potential $935M imetelstat deal with Janssen

Nov. 17, 2014
By Michael Fitzhugh
Geron Corp.'s savior has arrived, with Janssen Biotech Inc. pledging $35 million up front plus $900 million in potential milestone payments for an exclusive license to the company's sole pipeline asset, imetelstat.
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Russia aims to welcome drug developers, trials

Nov. 14, 2014
By Michael Fitzhugh
As Russia's efforts to bolster its domestic pharma R&D investment grow, the country is becoming more friendly to clinical trial sponsors, according to an executive at privately held R-Pharm, a Moscow-based drug manufacturer and wholesaler.
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Triphase streamlining early stage explorations for Celgene Corp.

Nov. 12, 2014
By Michael Fitzhugh
Triphase Accelerator Corp., a tiny drug developer with big backing from a Celgene Corp. deal, is pushing to bring economic rationality to the long haul between investigational new drug application filings and phase II proof of concept.
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Dendreon plunges into bankruptcy, pledging Provenge will flow

Nov. 11, 2014
By Michael Fitzhugh
Battered and bruised Dendreon Corp. has filed for Chapter 11 bankruptcy protection, assuring patients the Seattle company's prostate cancer treatment, Provenge (sipuleucel-T), will remain available as it advances plans to restructure its debt, either through a stand-alone recapitalization or company sale.
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