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Home » Authors » Michael Fitzhugh

Michael Fitzhugh

Articles

ARTICLES

Adaptimmune signs $46.5M deal for Universal Cells gene editing tech

Dec. 2, 2015
By Michael Fitzhugh
Adaptimmune Therapeutics plc, a U.K.-based immunotherapy developer, has agreed to pay Seattle-based start-up Universal Cells Inc. $5.5 million up front and up to $41 million in milestones for an exclusive global license to a gene editing technology that could lead to the creation of new allogeneic T-cell therapies.
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Growing access to medicines drives rising costs, IMS institute finds

Nov. 30, 2015
By Michael Fitzhugh
Despite headline-grabbing controversies over the high cost of cancer, hepatitis C and other drugs in the U.S., the path to a projected $1.4 trillion in global total spending on medicines in 2020 will be driven not just by pricey prescriptions in developed markets, but also by increased access to medicines in low- and middle-income countries, according to a new report by the IMS Institute for Healthcare Informatics.
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Samsung Bioepis lands positive CHMP opinion for Enbrel biosimilar

Nov. 25, 2015
By Michael Fitzhugh
Plans to launch the first biosimilar of Enbrel (etanercept, Amgen Inc.) in Europe are taking a big step forward with receipt by Samsung Bioepis Co. Ltd. of a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP). If approved by the European Commission (EC) as expected, it would become the first subcutaneous anti-TNF biosimilar there. It is one of three Bioepis biosimilars that Biogen Inc. has rights to commercialize in the EU and other countries.
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Samsung Bioepis lands positive CHMP opinion for Enbrel biosimilar

Nov. 23, 2015
By Michael Fitzhugh
Plans to launch the first biosimilar of Enbrel (etanercept, Amgen Inc.) in Europe are taking a big step forward with receipt by Samsung Bioepis Co. Ltd. of a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP).
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Gurnet Point commits $600M to development-focused start-up Boston Pharmaceuticals

Nov. 20, 2015
By Michael Fitzhugh
Just five months after former Sanofi SA chief Chris Viehbacher took charge of the $2 billion health care fund Gurnet Point Capital, he's launching a drug development venture dedicated to transforming undeveloped but promising molecules into a portfolio of high-quality, phase III-ready assets.
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NASH players map next steps, including phase III study for Genfit

Nov. 17, 2015
By Michael Fitzhugh
SAN FRANCISCO – Drugmakers targeting nonalcoholic steatohepatitis (NASH) unleashed a torrent of new data and plans at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in San Francisco over the weekend, including updates on late-stage studies and news of early progress on efforts to minimize reliance on invasive liver biopsies to identify patients with the disease.
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Gilead, BMS push ahead with HCV combos, give new hope to GT3 patients

Nov. 17, 2015
By Michael Fitzhugh
SAN FRANCISCO – New clinical data from Gilead Sciences Inc. and Bristol-Myers Squibb Co., presented at the American Association for the Study of Liver Diseases Annual Meeting added support to the drugmakers' cases for the efficacy of therapeutic combinations capable of battling HCV, especially among those patient with hard-to-treat cases.
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Derma dumps DFU trial for futility, exits drug development

Nov. 13, 2015
By Michael Fitzhugh

Derma dumps DFU trial for futility, exits drug development

Nov. 13, 2015
By Michael Fitzhugh
Derma Sciences Inc. is quitting the drug development business to focus exclusively on wound care devices after a committee monitoring a phase III trial of its diabetic foot ulcer (DFU) drug, aclerastide (DSC127), recommended stopping trial enrollment based on futility.
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DREAMing together to find cancer therapy combinations that work

Nov. 13, 2015
By Michael Fitzhugh
Individually speaking, it's safe to call regulatory genomics, systems biology and network visualization experts a pretty clever bunch. But how smart are they together? A series of crowdsourced research challenges, mounted by IBM Research, Sage Bionetworks and big pharma is aiming to find out.
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