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BioWorld - Friday, May 1, 2026
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

FDA lifts clinical hold on Neuroderm trials for drug-device combo in PD

May 11, 2015
By Michael Fitzhugh
Neuroderm Ltd. shares (NASDAQ:NDRM) rose $1.24, or 10.9 percent, to close at $12.62 on Friday as investors welcomed the lifting of an FDA clinical hold that was blocking progress on U.S. studies of the company's Parkinson's disease treatments ND0612H and ND0612L.
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Phosphate Therapeutics moves PT20 toward phase III after positive phase IIb

May 8, 2015
By Michael Fitzhugh
A new experimental phosphate binder advanced by privately held Phosphate Therapeutics Ltd. to best existing treatments in moderating outsize serum phosphate levels for patients with dialysis-dependent chronic kidney disease appeared safe and effective in a pivotal phase IIb study.
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Building value through regional licensing; global dealmakers get guidance on Japan

May 6, 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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Exelixis and Nektar gain ground, beat expectations

May 4, 2015
By Michael Fitzhugh
a href="https://cortellis.thomsonreuterslifesciences.com/ngg/qsearch/Exelixis%0D" target="_blank">Exelixis Inc. shares (NASDAQ:EXEL) climbed as much as 14 percent Friday on better-than-expected first quarter earnings, halved R&D costs and the hope that cabozantinib, which fizzled in a pivotal study for prostate cancer, would blaze brighter in METEOR, a phase III study in metastatic renal cell carcinoma (mRCC) reporting top-line data by the end of the second quarter or early in the third quarter.
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NIH, FDA leaders react: Appeciation, concern greet lawmakers discussing 21st Century Cures Act draft

May 1, 2015
By Michael Fitzhugh

Appreciation, concern greet lawmakers discussing draft for 21st Century Cures Act

May 1, 2015
By Michael Fitzhugh
"Thank you, thank you, thank you, thank you." That's how NIH's deputy director for science, outreach and policy, Kathy Hudson, began to sum up her agency's gratitude for millions of dollars of new NIH funding called for in a new draft of the proposed 21st Century Cures Act discussed before a House subcommittee Thursday.
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Sanbio IPO raises $67M to carry stroke therapy forward

April 30, 2015
By Michael Fitzhugh
Sanbio Inc., a small trans-Pacific cell therapy company leveraging Japan's efforts to foster regenerative medicine development, has completed an IPO of shares (TYO:4592) on the Tokyo Stock Exchange to help it advance SB623, its lead mesenchymal stem cell-based treatment for chronic stroke.
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Intarcia lands $225M royalty deal to carry drug pump to launch

April 29, 2015
By Michael Fitzhugh
Royalty investors backing a matchstick-sized implantable drug pump in late-stage testing by Intarcia Therapeutics Inc. invested $225 million in the company to carry the first version of the device, delivering exenatide to type 2 diabetics, through potential approval and early launch in 2017.
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Amgen's Q1 earnings rise as it charges more, spends less on R&D

April 23, 2015
By Michael Fitzhugh
Markups on Amgen Inc.'s best-selling drugs, Enbrel (etanercept) and Neulasta (pegfilgrastim), and downsized R&D spending helped the company boost first quarter net income by 51 percent compared to a year ago.
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Teva makes $40B offer for Mylan; seeks to build generics powerhouse

April 22, 2015
By Michael Fitzhugh
Teva Pharmaceutical Industries Ltd., the world's largest generic drugmaker, put an end to speculation about its interest in acquiring Mylan NV on Tuesday, making a $40.1 billion bid for the generics heavyweight, valuing it at $82 per share in a half cash, half stock offer.
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