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Home » Authors » Michael Fitzhugh

Michael Fitzhugh

Articles

ARTICLES

BreathID study begins:Exalenz breathes life into trial of new liver cancer diagnostic

June 5, 2015
By Michael Fitzhugh

Halozyme's combo drug to get last laugh in pancreatic cancer fight?

June 2, 2015
By Michael Fitzhugh
CHICAGO – Fresh off the FDA's April blessing of its plans to move the experimental metastatic pancreatic cancer therapy PEGPH20 into phase III early next year, Halozyme Therapeutics Inc. shared interim data from the ongoing second stage of its randomized phase II study of the drug at the ASCO meeting.
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NDA coming soon as Clovis unveils data in ovarian, NSCLC

June 2, 2015
By Michael Fitzhugh
CHICAGO – Clovis Oncology Inc. took a big step ahead in preparations for filing its new drug application (NDA) for the experimental non-small-cell lung cancer (NSCLC) therapy, rociletinib, showcasing data from an ongoing phase II study testing the drug in a group of heavily pre-treated patients, most of whom had developed resistance to current treatments.
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Battling cancer drug access gaps, one policy change at a time

June 2, 2015
By Michael Fitzhugh
CHICAGO – Despite growing access to ever-better cancer therapies in major markets, underpinned by the many scientific advances presented at this year's ASCO annual meeting, low and middle-income countries are struggling to keep pace.
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Eisai's Halaven delivers precious months for sarcoma patients

June 2, 2015
By Michael Fitzhugh
CHICAGO – The first randomized phase III study to show an overall survival benefit in patients with the aggressive soft-tissue sarcomas was unveiled Saturday at the ASCO annual meeting.
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Immunogen soars on early ovarian cancer data, big phase II plans

June 2, 2015
By Michael Fitzhugh
CHICAGO – Immunogen Inc. shares (NASDAQ:IMGN) shot up 72 percent to close at $15.44 Monday on news that about half of the heavily pre-treated patients in a phase I study of the company's single agent ovarian cancer therapy candidate demonstrated overall response (ORR), besting the 15 percent to 20 percent response rate typically seen in platinum-resistant ovarian cancer patients and giving the company confidence to plan a possible pivotal phase II trial for late 2015.
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Merck inks immunotherapy links with Dynavax, Tesaro during ASCO

June 2, 2015
By Michael Fitzhugh
CHICAGO – Merck & Co. Inc. and Dynavax Technologies Corp. have agreed to pursue dual trials investigating the potential for combining immunotherapies from both companies' pipelines to help patients with multiple cancers, an arrangement that could raise visibility for Dynavax at a time when it's also advancing SD-101 on its own.
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Opdivo trial homes in on those most likely to benefit; PD-L1 as biomarker

June 1, 2015
By Michael Fitzhugh
CHICAGO – Bristol-Myers Squibb Co.'s Opdivo (nivolumab), approved in March to treat certain patients with squamous non-small-cell lung cancer (NSCLC), can also provide significant benefit to patients with the more common nonsquamous form of NSCLC, especially those with tumors expressing high levels of tumor programmed death-ligand 1 (PD-L1), according to findings from the phase III CheckMate-057 study, presented Friday at the American Society of Clinical Oncology (ASCO) meeting.
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Mast starts phase III extension study for sickle cell disease drug

May 27, 2015
By Michael Fitzhugh
Mast Therapeutics Inc. has initiated a new open-label extension study to evaluate repeat dosing of its experimental sickle cell disease (SCD) therapy, vepoloxamer (MST-188), in patients who have completed the company's phase III trial, EPIC, and are hospitalized for a subsequent vaso-occlusive crisis, a painful event in which sickled red blood cells "stick" to the endothelium and to each other and leads to blocking circulation and causing tissue damage.
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Chinese consortium snaps up Ambrx to bring new drugs to Chinese patients

May 26, 2015
By Michael Fitzhugh

A consortium of some of China’s biggest health care players is snapping up trans-Pacific protein therapeutics developer Ambrx Inc. for an undisclosed amount in a bid to accelerate the introduction of innovative, and presumably more profitable, therapies to the Chinese market.


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