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BioWorld - Sunday, January 11, 2026
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Autologous wound care product shows promise in swine models

June 9, 2017
By Michael Fitzhugh
PolarityTE Inc., a Salt Lake City-based regenerative medicine and tissue engineering company, has reported preclinical results demonstrating that its lead candidate, SkinTE, regenerated full-thickness, organized skin and hair follicles in third-degree burn wounds.
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Abbvie sows more post-Humira seeds with some new late-stage RA data

June 8, 2017
By Michael Fitzhugh

Abbvie Inc.'s late-stage oral JAK1 inhibitor, a candidate that could help fill a key gap in the drugmakers' revenue as Humira's (adalimumab) U.S. market exclusivity lapses, met all primary and secondary endpoints in a phase III rheumatoid arthritis (RA) study.

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Blood, brains and yogurt parry pathogens

June 7, 2017
By Michael Fitzhugh
NEW ORLEANS – As antimicrobial-resistant infections continue to inspire the search for modern cures, microbiologists are also looking to some ancient and unexpected corners of the world for progress. Alligator blood, cockroach brains and even commercial yogurt may harbor bug-beating elements, recent research presented at ASM Microbe 2017 suggests. All explorations were early in their progress. But each offers tantalizing invitations to further research.
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Viamet vanquishes yeast infections in phase IIb

June 6, 2017
By Michael Fitzhugh
NEW ORLEANS – Viamet Pharmaceuticals Inc.'s lead fungal infection fighter, oral VT-1161 (oteseconazole), met the primary endpoint of a phase IIb trial in recurrent yeast infections, besting a placebo in all arms of the trial and laying the groundwork for the company to finalize its phase III protocol ahead of a meeting scheduled shortly with the FDA to discuss next steps, President and CEO Bob Schotzinger told BioWorld Today.
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Entasis Therapeutics targets superbugs, costly hospital stays with new candidate

June 6, 2017
By Michael Fitzhugh
NEW ORLEANS – Astrazeneca plc spinout Entasis Therapeutics Inc. is moving to take on some of the world's toughest infections with a new candidate that it said could be the first oral therapy for drug-resistant gram-negative infections in a decade. The beta-lactamase inhibitor, ETX-0282, is headed into animal testing soon and could enter phase I in early 2018, company executives told BioWorld Today, making it the company's third clinical candidate.
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Novabiotics sees preclinical potential in S. aureus killer

June 5, 2017
By Michael Fitzhugh
NEW ORLEANS – A preclinical antibiotic candidate under development at Novabiotics Ltd. called Luminaderm, or NP-108, could potentially offer clinicians a new way to head off troublesome nasal Staphylococcus aureus infections, if early data showcased at the American Society for Microbiology's (ASM) Microbe 2017 meeting, holds up to scrutiny in the clinical trials.
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Antibiotics shortage requires disaster management tactics

June 5, 2017
By Michael Fitzhugh
NEW ORLEANS – Drug shortages, a persistent thorn in the side of health care providers across the spectrum, have moved from troubling to hazardous, speakers said today at the American Society for Microbiology's (ASM) Microbe 2017 meeting.
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NLS phase II results advance effort to carve out alternative ADHD drug niche

June 1, 2017
By Michael Fitzhugh
NLS Pharma Group’s lead compound, NLS-1 (mazindol), more than halved a common measure of attention deficit hyperactivity disorder (ADHD) symptoms in 55 percent of treated adults vs. 15.8 percent of placebo-treated subjects in a randomized phase II trial.
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FDA rejects Sunovion Pharmaceuticals' new drug app for COPD drug and nebulizer

May 31, 2017
By Michael Fitzhugh

FDA rejects Sunovion new drug app for COPD drug and nebulizer

May 31, 2017
By Michael Fitzhugh
An FDA complete response letter (CRL) for the chronic obstructive pulmonary disease (COPD) therapy SUN-101 (glycopyrrolate) and the Eflow nebulizer used to deliver it is sending Sunovion Pharmaceuticals Inc. back into talks with the agency and pushing out the potential realization of up to $210 million in commercial milestones for former backers of Elevation Pharmaceuticals Inc., from which Sunovion acquired the program in 2012.
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