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Home » Authors » Michael Fitzhugh

Michael Fitzhugh

Articles

ARTICLES

Celgene misses Q4 estimate, announces CEO transition

Jan. 12, 2016
By Michael Fitzhugh
SAN FRANCISCO – With a global market still wobbly after last week's rough start, Celgene Corp. chief Bob Hugin sought to deliver a reassuring picture for investors long on Celgene while also announcing that he'd hand the reigns to a new CEO, current President and Chief Operating Officer Mark Alles, on March 1. Jackie Fouse will be promoted to president and chief operating officer.
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Novartis strikes $170M pact with Surface Oncology

Jan. 12, 2016
By Michael Fitzhugh
SAN FRANCISCO – Novartis AG moved to expand its immuno-oncology pipeline Monday through a strategic alliance and licensing agreement with Cambridge, Mass.-based Surface Oncology Inc. worth up to $170 million in up-front, equity and near-term milestone payments.
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Mylan, Momenta strike $245M biosimilars deal

Jan. 11, 2016
By Michael Fitzhugh
Mylan NV and Momenta Pharmaceuticals Inc. agreed to work together to develop, manufacture and commercialize six of Momenta's current biosimilar candidates under an exclusive new deal.
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Dynavax shares leap on phase III Heplisav-B data; BLA later this year

Jan. 8, 2016
By Michael Fitzhugh
Dynavax Technologies Corp. investors rejoiced Thursday as positive top-line results from a phase III trial comparing the safety and immunogenicity of its investigational hepatitis B vaccine, Heplisav-B, to Glaxosmithkline plc's Engerix-B emboldened the Berkeley, Calif.-based company to resubmit its biologics license application (BLA) for the therapy by the end of March.
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Biogen options Rodin buy with $485M R&D deal, equity investment

Jan. 7, 2016
By Michael Fitzhugh
Rodin Therapeutics Inc. has landed a multi-year neuronal epigenetics R&D deal with Biogen Inc. that includes an undisclosed up-front payment for an option to buy the small cognitive disorders specialist as well as potential milestone payments of up to $485 million should the acquisition come to pass.
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Millendo raises $62M to advance in-licensed Astrazeneca endocrine disease therapy

Jan. 6, 2016
By Michael Fitzhugh
Millendo Therapeutics Inc., financed with a new $62 million series B investment led by New Enterprise Associates (NEA), has exclusively licensed rights to develop and commercialize MLE4901, a phase II neurokinin 3 receptor antagonist licensed from Astrazeneca plc for the treatment of polycystic ovary syndrome.
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Teva, Active stop high dose of MS drug after heart troubles surface

Jan. 5, 2016
By Michael Fitzhugh
Teva Pharmaceutical Industries Ltd. and Active Biotech AB said that testing of 1.2 mg and 1.5 mg doses of the experimental multiple sclerosis (MS) therapy laquinimod have been discontinued in two ongoing studies of the drug after eight patients experienced non-fatal cardiovascular (CV) events.
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Pozen pays 'Tribute' to Canada with Aralez Pharma formation

Dec. 30, 2015
By Michael Fitzhugh
The long-planned debut of Aralez Pharmaceuticals Inc., a Toronto-based company conceived by specialty pharma veteran Adrian Adams as a profitable and tax-advantaged combination of Pozen Inc. and Tribute Pharmaceuticals Canada Inc., moved closer to finality this week with the successful registration of Aralez shares on Nasdaq and the ironing out of an aspirin supply issue that has weighed on the company since 2014.
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FDA approves Astrazeneca gout drug Zurampic

Dec. 24, 2015
By Michael Fitzhugh
A week earlier than expected, Astrazeneca plc has gained FDA approval to market Zurampic (lesinurad), a new drug for treating high levels of uric acid in the blood associated with gout when given together with xanthine oxidase inhibitors (XOIs). It's the 45th new molecular entity approved by the agency this year.
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FDA approves Actelion's drug to 'PAH'mp the brakes on lung disease progress

Dec. 23, 2015
By Michael Fitzhugh
Christmas came early for Actelion Ltd., as the FDA approved its pulmonary arterial hypertension (PAH) treatment Uptravi (selexipag), putting the company on track to launch the oral prostacyclin receptor agonist early next month for use in delaying PAH progression and patients' risk of hospitalization for symptoms related to the condition. The therapy will be marketed by San Francisco-based Actelion Pharmaceuticals US Inc.
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View All Articles by Michael Fitzhugh

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