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BioWorld - Tuesday, January 27, 2026
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

FDA OKs lixisenatide for type 2 diabetics, sets stage for Lantus combo

July 29, 2016
By Michael Fitzhugh
An expected, FDA approval of the type 2 diabetes drug Adlyxin (lixisenatide) finally arrived for Sanofi SA, following initial withdrawal of a new drug application in late 2013 as the French drugmaker sought to establish cardiovascular safety of the GLP-1 receptor agonist.
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Tokai terminates pivotal prostate cancer trial; stock plummets

July 27, 2016
By Michael Fitzhugh
Tokai Pharmaceuticals Inc. called off a pivotal phase III trial comparing its triple-acting prostate cancer drug, galeterone, to Xtandi (enzalutamide, Medivation Inc.) after a data monitoring committee determined the trial was unlikely to meet its primary endpoint.
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Tobira Therapeutics' shares tumble on non-alcoholic steatohepatitis data

July 26, 2016
By Michael Fitzhugh
Shares of Tobira Therapeutics Inc. lost more than half their value Monday, falling 60 percent to close at $4.50 on news that Centaur, a phase IIb study of its experimental NASH drug cenicriviroc, failed to meet its primary endpoint, knocking two points off a score used to evaluate changes in the condition after a year of treatment.
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Puma pounce: NDA filing arrives with extended disease-free survival data

July 25, 2016
By Michael Fitzhugh
Shares of Puma Biotechnology Inc. (NYSE:PBYI) rose 20.3 percent Friday on word that the company has submitted an FDA new drug application (NDA) for its lead candidate, neratinib, along with updated data showing that the drug's absolute invasive disease-free survival (DFS) benefit remained steady over time during a phase III study including the company's initial intent-to-treat (ITT) population, women with early stage HER2-positive breast cancer previously treated with Herceptin (trastuzumab, Roche AG).
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Big data's big challenges in drug discovery

July 25, 2016
By Michael Fitzhugh
Given the blistering rate at which researchers of all stripes, academic and corporate, are accumulating data on the molecular nature of disease, applying those data in drug discovery efforts is a natural next step. But, even with plentiful data and computing power, multiple roadblocks to reducing the time, costs and productivity of discovery remain.
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Big bounce for Jounce: Firm lands $2.56B Celgene immuno-oncology collaboration

July 20, 2016
By Michael Fitzhugh
Jounce Therapeutics Inc. will receive a $225 million up-front payment and a $36 million equity investment as part of a five-candidate immuno-oncology (I-O) collaboration with Celgene Corp.
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Pivotal trial Evoke's failure for diabetic gastroparesis drug

July 19, 2016
By Michael Fitzhugh
A missed endpoint in the pivotal trial of its sole candidate sent shares of Evoke Pharma Inc. (NASDAQ:EVOK) down 73.1 percent to close at $2.89 on Monday as the company's nasal formulation of the proven diabetic gastroparesis drug metoclopramide, EVK-001, failed to achieve its primary endpoint of improving symptoms at week four of the all-female study.
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IND success at Eleven puts eye drug on right track

July 11, 2016
By Michael Fitzhugh
Conditional capture of a $22.5 million milestone payment from Roche Holding AG sent Eleven Biotherapeutics Inc. shares climbing Friday, triggered by effectiveness of an IND for its interleukin-6 antagonist, EBI-031.
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Medivation showcases PARP inhibitor's potential, baiting bidders

July 8, 2016
By Michael Fitzhugh
Another "multibillion-dollar opportunity" is how Medivation Inc. CEO David Hung framed talazoparib, the company's late-stage PARP inhibitor, in an investor call late Wednesday.
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Partners kick off phase III avelumab trial in previously untreated ovarian cancer

July 7, 2016
By Michael Fitzhugh

Merck KGaA and Pfizer Inc. have begun a phase III registration study to test the programmed cell death ligand 1 (PD-L1) inhibitor avelumab in combination with or as follow-on treatment to platinum-based chemotherapy in patients with metastatic, previously untreated epithelial ovarian cancer.


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