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BioWorld - Wednesday, March 4, 2026
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Merck drops vintafolide, returns rights to Endocyte

June 19, 2014
By Michael Fitzhugh
Endocyte Inc. shares plummeted Tuesday as Merck & Co. Inc. pulled the plug on its $1 billion vintafolide partnership, returning global rights to Endocyte's most advanced small-molecule drug conjugate (SMDC).
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Serenus Biotherapeutics looks to tap Africa's underdeveloped market

June 18, 2014
By Michael Fitzhugh
Sub-Saharan Africa's economic takeoff has carried a growing number of the region's 1.1 billion people ahead on a wave of innovation, bringing new advances in mobile commerce, bioagriculture and green energy. Innovative drugs from the West, however, have arrived much more slowly.
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Oncomed Pharmaceutical halts phase I trials of Bayer-partnered cancer drugs

June 16, 2014
By Michael Fitzhugh
Oncomed Pharmaceuticals Inc.'s shares dipped as much as 24 percent briefly after the company halted six phase Ib trials testing two Bayer AG-partnered monoclonal antibodies targeting the Wnt pathway in cancer. Trial sites reported "on-target mild-to-moderate" bone-related adverse events, moving the company to stop the trials to amend study protocols for all eight ongoing trials of vantictumab and Fzd8-Fc.
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Epirus touts biosimilar Remicade progress, boosting Zalicus shares

June 13, 2014
By Michael Fitzhugh
Shares of Zalicus Inc., the company that will soon give Epirus Pharmaceuticals Inc. entrée to the public market through a reverse merger, shot up 39.8 percent Thursday as Epirus promoted trial results showing that BOW015, its biosimilar to the anti-tumor necrosis factor therapy Remicade (infliximab, Johnson & Johnson) compared favorably to the branded drug in a phase III equivalence trial.
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Adamas launches pivotal trial of CNS drug

June 11, 2014
By Michael Fitzhugh
Adamas Pharmaceuticals Inc., primed by a recent $25 million milestone payment on an unrelated program, is starting a pivotal phase III study to test the ability of ADS-5102, its experimental extended-release formulation of generic drug amantadine, to quell involuntary movements tied to Parkinson's disease (PD) treatment.
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Novavax prices $100M offering to fund vaccines pipeline

June 9, 2014
By Michael Fitzhugh
Novavax Inc. said it plans to raise $100 million to advance its pipeline of vaccines for flu, respiratory syncytial virus (RSV) and other viruses as the company prepares to test its most advanced programs in phase II trials.
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Start-up Ocugen eyes new opthalmology opportunities

June 6, 2014
By Michael Fitzhugh
Entrepreneur Shankar Musunuri's newest venture, Ocugen Inc., is jumping into the race to develop a treatment for the rare disease retinitis pigmentosa (RP) and another therapy for wet age-related macular degeneration (AMD), with two preclinical biologics exclusively licensed from the University of Colorado.
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Trevi preps trials of drug to ditch severe itch with $25M series B

June 5, 2014
By Michael Fitzhugh
Trevi Therapeutics Inc. has landed a tranched $25 million series B financing to support two pivotal trials of Nalbuphine extended release (ER), its oral opioid in development for the treatment of two forms of severe itching. TPG Biotech, which has funded the company since its founding, was the sole investor.
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Teva padding migraine franchise; acquiring Labrys Biologics in potential $825M deal

June 4, 2014
By Michael Fitzhugh
Teva Pharmaceutical Industries Ltd. is raising its bet in the migraine-fighting market by buying Labrys Biologics Inc. for $200 million up front and up to $625 million in pre-launch milestone payments. The single-compound company's once-monthly injectable migraine prevention drug, LBR-101, could capture $2 billion to $3 billion in sales, according to Teva estimates, adding a lucrative new dimension to its growing portfolio of pain treatments.
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Adherex reports positive data on hearing loss drug

June 3, 2014
By Michael Fitzhugh
Positive new phase III data showing Adherex Technologies Inc.'s sodium thiosulfate (STS) reduced hearing loss in children with cancer on cisplatin chemotherapy moved the company a step closer to filing a new drug application for the orphan drug next year. If approved it would become the first such therapy available in the U.S.
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