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BioWorld - Wednesday, December 31, 2025
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Novavax showcases RSV vaccine success in elder-targeted phase II

Aug. 11, 2015
By Michael Fitzhugh
A phase II trial of an experimental respiratory syncytial virus (RSV) vaccine created by Novavax Inc. prevented symptoms of the common and sometimes deadly virus in as many as 46 percent of older adults, giving the company a strong foundation ahead of a planned pivotal phase III trial that could start as early as the fourth quarter and boding well for another program testing the vaccine to protect infants via maternal immunization scheduled to report data in September.
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Orexigen settles Takeda dispute, seeks expanded reach for obesity drug in South Korea

Aug. 7, 2015
By Michael Fitzhugh
Orexigen Therapeutics Inc. reported higher-than-expected second quarter revenues, helped by royalties on U.S. sales of obesity drug Contrave (naltrexone and bupropion).
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Avax resolves debts and plots course to restart clinical work

Aug. 6, 2015
By Michael Fitzhugh
Avax Technologies Inc., a Philadelphia-based immunotherapy specialist that ran into financing troubles in 2009, has settled debts it owed the Cancer Treatment Centers of America Inc. (CTCA) and Firebird Management LLC, repaying both parties with equity as it advances plans to re-launch a pivotal clinical study of M-Vax, its candidate immunotherapy for melanoma, and explore resuming a trial of O-Vax, a potential immunotherapeutic vaccine to treat ovarian cancer.
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Regeneron's robust Eylea sales lift outlook as well as shares

Aug. 5, 2015
By Michael Fitzhugh
Surging global sales of Regeneron Pharmaceuticals Inc.'s blockbuster Eylea (aflibercept) drove company revenues 50 percent higher during the second quarter, leading it to raise full-year guidance for Eylea's growth.
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Vertex raises outlook on Kalydeco as analysts keep eyes on Orkambi uptake

Aug. 4, 2015
By Michael Fitzhugh

Rising Kalydeco (ivacaftor) sales carried Vertex Pharmaceuticals Inc.'s second quarter revenue 20 percent higher, giving the company confidence to raise projected sales of the cystic fibrosis (CF) drug as it anticipates expanding its geographic reach and label to reach additional patients.

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Contravir tests ability of FV-100 to turn down shingles pain

Aug. 4, 2015
By Michael Fitzhugh
Contravir Pharmaceuticals Inc. has enrolled the first patient in what could be the sole pivotal trial of FV-100, an oral herpes zoster therapy, that it hopes to market as a treatment for both shingles and the reduction of post-herpetic neuralgia (PHN), a painful shingles-associated condition that becomes more common as people age.
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Amgen Q2 beat expectations, boosts full-year guidance

Aug. 3, 2015
By Michael Fitzhugh
Amgen Inc. shares (NASDAQ:AMGN) briefly hit a record high of $181.81 on Friday as the drugmaker reported a higher-than-expected second quarter profit, driven in part by strong sales of Enbrel (etanercept), Prolia and Xgeva (denosumab) and cost-cutting. The drugmaker also raised its full-year guidance as it moved to launch new products, such as the world’s first approved PCSK9 inhibitor, Repatha (evolocumab).
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Ariad strikes synthetic royalty deal with PDL to back cancer programs

July 30, 2015
By Michael Fitzhugh
Ariad Pharmaceuticals Inc. agreed to pay mid-single-digit royalties on futures sales of Iclusig (ponatinib) to PDL Biopharma Inc. in exchange for up to $200 million in financing intended to accelerate testing of brigatinib, an anaplastic lymphoma kinase (ALK) inhibitor it is developing to treat non-small-cell lung cancer (NSCLC), and to continue its ongoing initiatives supporting both drugs.
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Sanofi strikes $2.2B immuno-oncology pact with Regeneron

July 29, 2015
By Michael Fitzhugh
Sanofi SA has pledged to invest up to $2.2 billion in a new collaboration with Regeneron Pharmaceuticals Inc. in which the longtime partners will jointly develop and commercialize the programmed cell death protein-1 (PD-1) inhibitor REGN-2810 and other new immuno-oncology antibodies.
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Oncobiologics raises $31M to advance biosimilars pipeline, platform

July 28, 2015
By Michael Fitzhugh
Biosimilars developer Oncobiologics Inc. has landed a $31 million financing to support continued expansion and development of its platform and pipeline, which includes clinical-stage biosimilars of Humira (adalimumab, Abbvie Inc.), Avastin (bevacizumab, Roche AG), and nine other preclinical candidates poised to take on off-patent biologics.
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