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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Solid Biosciences lands $50M series C to advance DMD gene therapy

March 31, 2017
By Michael Fitzhugh
Solid Biosciences LLC completed the initial close of a $50 million series C financing that it said will help move its experimental gene therapy for Duchenne muscular dystrophy (DMD) into the clinic in the second half of this year. RA Capital Management and Bain Capital Life Sciences led the oversubscribed round, which follows a $42.5 million series B that first closed in 2015.
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Wisconsin CNS drug developer Promentis lands $26M series C

March 30, 2017
By Michael Fitzhugh
Promentis Pharmaceuticals Inc., a Milwaukee-based company developing therapies for central nervous system disorders (CNS), has completed a $26 million series C financing to help it advance its lead compound, SXC-2023, through phase II proof of concept in an undisclosed CNS indication for which it said no drug is currently approved in the U.S. or Europe. It expects the study will take about 12 months from start to finish.
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L.A. biopharma ramping up for clinical phase

March 29, 2017
By Michael Fitzhugh

FDA approves Regeneron’s Dupixent for atopic dermatitis after priority review

March 29, 2017
By Michael Fitzhugh
Regeneron Pharmaceuticals Inc. won FDA approval for its Sanofi SA-partnered biologic, Dupixent (dupilumab), as a treatment for adults with moderate to severe atopic dermatitis (AD) who are either not helped by topical drugs or for whom those therapies aren’t advised, a group estimated to encompass about 300,000 patients in the U.S.
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Max(imum) bone: L.A. biopharma is ramping up to the clinic

March 28, 2017
By Michael Fitzhugh
Primed with early stage research supporting the bone-building activity of its small-molecule alternative to existing therapies, Los Angeles-based Max Biopharma Inc. is on the hunt for a $12 million series A financing to help it move closer to filing FDA investigational device exemption (IDE) and new drug (IND) applications as it advances localized and systemic bone formation programs.
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Allergan, Foamix advance acne drugs with contrasting results

March 28, 2017
By Michael Fitzhugh
Positive data from dual phase III studies of oral sarecycline in moderate to severe acne poised originator Paratek Pharmaceuticals Inc. to earn a $5 million milestone payment from partner Allergan plc upon submission of a new drug application, slated to arrive before year-end.
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Xenon kills acne program after failure of its midstage trial

March 27, 2017
By Michael Fitzhugh
Simon Pimstone, president and CEO of Xenon Pharmaceuticals Inc., said the company is dropping development of its moderate to severe facial acne candidate, XEN801, after the topical drug failed to separate from placebo in clearing lesions over the course of a 12-week phase II study.
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Big medical device players navigating innovative paths to success in 2017

March 24, 2017
By Michael Fitzhugh

Big device players are navigating new paths to success in 2017

March 24, 2017
By Michael Fitzhugh
SAN FRANCISCO – While the medical device industry remains true to its roots, seeking to improve the duration and quality of lives across many conditions, the $371 billion industry is increasingly seeking ways to push beyond incremental innovation, Jefferies LLC managing director Raj Denhoy told attendees at the Cooley Medical Technology Growth Conference on Thursday.
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Newron Pharmaceuticals gains hard-won FDA approval for Parkinson's drug

March 22, 2017
By Michael Fitzhugh
Italy's Newron Pharmaceuticals SpA has gained FDA approval to market its Parkinson's disease (PD) drug, Xadago (safinamide), for patients who are currently taking levodopa/carbidopa and experiencing "off" episodes, or periods in which their medications are not working well, causing an increase in PD symptoms.
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