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BioWorld - Thursday, April 2, 2026
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

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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Shares skyrocket as Sarepta launches rolling NDA for DMD drug eteplirsen

May 20, 2015
By Michael Fitzhugh
Sarepta Therapeutics Inc. shares rose more than 60 percent to $26.24 on Wednesday after the company said it would start a rolling submission of its new drug application (NDA) for the Duchenne muscular dystrophy (DMD) drug eteplirsen.
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Intercept Pharma to launch pivotal phase III in NASH

May 20, 2015
By Michael Fitzhugh
Following extensive talks with the FDA and European regulators, Intercept Pharmaceuticals Inc. has nailed down plans for a rigorous pivotal phase III study testing obeticholic acid (OCA), the company's lead candidate, in about 2,500 patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis, a population representing potentially more than 14 million patients in the U.S. alone.
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Trial miss leaves no dry eye for Eleven Biotherapeutics investors

May 19, 2015
By Michael Fitzhugh
Eleven Biotherapeutics Inc.'s lead candidate EBI-005 failed to outperform a vehicle control in a phase III study of moderate to severe dry eye disease, driving company shares (NASDAQ:EBIO) down 69.2 percent to $3.69 on Monday.
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Angion advances BB3 with phase III in kidney transplant recipients

May 15, 2015
By Michael Fitzhugh
Angion Biomedica Corp. plans to soon begin enrolling a phase III study of BB3, an organ-protecting regenerative treatment it is testing in kidney transplant recipients with delayed graft function (DGF), a situation in which the organ fails to function properly, pushing patients onto dialysis after surgery.
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Sanofi exercises option to develop Selecta's celiac treatment

May 14, 2015
By Michael Fitzhugh
Sanofi SA is expanding its work with Selecta Biosciences Inc., exercising a multi-million dollar option to license Selecta's antigen-specific immunotherapy platform to underpin a research-stage program targeting the severe gluten allergy celiac disease.
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Building value through regional licensing; global dealmakers get guidance on Japan

May 13, 2015
By Michael Fitzhugh
SAN FRANCISCO – With international dealmaking often a key element of the biopharma asset development adventure, the path to success in Japan took center stage during the first day of Allicense, an annual pilgrimage for the industry's top business development pros.
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IPO now: Axovant flies from formation to $172.5M offering

May 13, 2015
By Michael Fitzhugh
Axovant Sciences Ltd., a small Bermuda-based company formed in October to carry a phase-III-ready asset bought from Glaxosmithkline plc through approval in Alzheimer's disease (AD), has filed for an IPO of up to $172.5 million.
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Parkinson's Disease: FDA lifts clinical hold on Neuroderm for drug-device combo in PD

May 12, 2015
By Michael Fitzhugh

Ligand broadens royalty rights portfolio after beating Q1 views

May 12, 2015
By Michael Fitzhugh
With rising royalty revenue boosting its first quarter earnings, Ligand Pharmaceuticals Inc. added rights to potential future milestone and royalty payments on 15 biologic development programs from its existing partner, Selexis SA, for $4 million in cash.
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