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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Precision Care: Plotting the path to NIH's 1 million participant study

July 2, 2015
By Michael Fitzhugh

Plotting the path to NIH's 1 million participant study

July 2, 2015
By Michael Fitzhugh
Academic and non-profit research leaders intent on expanding the oft-constrained boundaries of clinical research sought to introduce clarity and caution ahead of the NIH's ambition plan to build a 1 million-participant cohort to support research into precision care approaches as part of the new Precision Medicine Initiative (PMI), launched in January.
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Solid 'Opera' performance for ocrelizumab; Roche plans 2016 filing in MS

July 1, 2015
By Michael Fitzhugh
Roche AG is planning early 2016 regulatory filings to seek approvals for ocrelizumab, a twice-yearly injectable multiple sclerosis (MS) therapy, after two phase III studies showed that it significantly reduced relapses and disability progression vs. Rebif (beta interferon 1a, EMD Serono Inc. and Pfizer Inc.) for people with relapsing MS, the most common form of the disease.
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Top-line diabetes data weigh on Vitae's shares

June 30, 2015
By Michael Fitzhugh
A type 2 diabetes drug discovered by Vitae Pharmaceuticals Inc. and partnered with Boehringer Ingelheim GmbH failed to meet Boehringer's primary efficacy endpoint – change in fasting plasma glucose – when combined with the common diabetes medicine metformin in an ongoing phase II study.
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Etubics immunotherapy candidate gains new backing, paving the path to phase III

June 29, 2015
By Michael Fitzhugh
Etubics Corp., a Seattle-based company developing targeted immunotherapies and vaccines, has gained fresh support from the National Cancer Institute (NCI) in its efforts to advance a multitargeted carcinoma immunotherapy.
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Alder seeks $200M in follow-on to support migraine drug ALD403

June 29, 2015
By Michael Fitzhugh
Just six months after completing an upsized $203.6 million follow-on offering in January, Alder Biopharmaceuticals Inc. is seeking an additional $200 million in a new offering of about 4.5 million shares (NASDAQ:ALDR) to back development and testing of ALD403, a calcitonin gene-related peptide blocker it's developing for migraine prevention.
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Troubling Transition: Alzheimer's drug appears safe, but not so effective

June 25, 2015
By Michael Fitzhugh
A phase II/III study of Transition Therapeutics Inc.'s lead neuropsychiatric drug, ELND005 (scyllo-inositol), found it about as good as a placebo in reducing the agitation and aggression that often surfaces in people with Alzheimer's disease (AD).
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Vical shares dive on herpes vaccine trial miss

June 24, 2015
By Michael Fitzhugh
Vical Inc. shares (NASDAQ:VICL) fell 43.6 percent to 80 cents after the firm shared top-line data showing that two forms of herpes simplex virus type 2 (HSV-2) vaccines formulated with its lipid-based adjuvant, Vaxfectin, missed the primary endpoint in a phase I/II study.
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Western Oncolytics lands $2.5M series A round

June 23, 2015
By Michael Fitzhugh
Western Oncolytics Ltd., a company developing an oncolytic immunotherapy for solid tumors, has raised a $2.5 million series A round from a group of private investors to help move its lead candidate, WO-12, into the clinic within the next two years.
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New Implantable Chip: Teva primes new delivery tech venture with $35M investment

June 22, 2015
By Michael Fitzhugh
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