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BioWorld - Tuesday, January 13, 2026
Home » Authors » Michael Fitzhugh

Michael Fitzhugh

Articles

ARTICLES

Astellas Pharma's acute myeloid leukemia trial doses first patient in new front for broad program

Aug. 30, 2017
By Michael Fitzhugh
A phase III trial testing Astellas Pharma Inc.'s acute myeloid leukemia (AML) candidate, gilteritinib, as a maintenance therapy after hematopoietic stem cell transplant (HCT) has dosed its first patient. It's the fourth late-stage trial testing the FLT3/Axl kinase inhibitor in an active landscape of increasingly tailored AML therapies. If successful, the study could help the Tokyo-based company establish a basis for a potentially broad label for the orphan-designated medicine.
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Atyr raising $45.8M in equity financing to back lung, cancer programs

Aug. 29, 2017
By Michael Fitzhugh
Atyr Pharma Inc. is raising $45.8 million in equity financing through a private placement expected to help it advance both its pulmonary disease-focused iMod.Fc program and the preclinical Project Orca, an immuno-oncology program from which it plans to identify the project’s first candidate.
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Novartis picks up rights to Xoma anti-IL-1 beta assets for $31M, plus debt payment

Aug. 28, 2017
By Michael Fitzhugh
Xoma Corp. is licensing to Novartis AG global commercial rights to its interleukin-1 (IL-1) beta antibody gevokizumab in the wake of Les Laboratories Servier’s decision last year to quit the asset.
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Boehringer NASH trial start adds €18M to Pharmaxis till

Aug. 25, 2017
By Michael Fitzhugh
Boehringer Ingelheim GmbH (BI) has started a phase IIa trial in nonalcoholic steatohepatitis (NASH) seeking insight on four different doses of BI-1467335, an anti-inflammatory drug it acquired from Sydney-based Pharmaxis Ltd. The kick-off triggered an €18 million (US$21.3 million) milestone payment for Pharmaxis. A €10 million (US$11.8 million) milestone tied to the launch of another phase II study in a second soon-to-be disclosed indication is expected later this year.
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Krystal IPO seeks up to $34.5M to back derm-focused gene therapies

Aug. 24, 2017
By Michael Fitzhugh
Krystal Biotech Inc., a company developing gene therapies for rare skin disorders, has filed to raise up to $34.5 million in an IPO. Its two preclinical programs, KB-103 for dystrophic epidermolysis bullosa (DEB) and KB-104 for Netherton syndrome, employ an engineered viral vector based on herpes simplex virus 1 and skin-optimized gene transfer.
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Astellas Pharma’s acute myeloid leukemia trial doses first patient in new front for broad program

Aug. 23, 2017
By Michael Fitzhugh
A phase III trial testing Astellas Pharma Inc.’s acute myeloid leukemia (AML) candidate, gilteritinib, as a maintenance therapy after hematopoietic stem cell transplant (HCT) has dosed its first patient. It’s the fourth late-stage trial testing the FLT3/Axl kinase inhibitor in an active landscape of increasingly tailored AML therapies. If successful, the study could help the company establish a basis for a potentially broad label for the orphan-designated medicine.
Read More

Saniona partner starts phase III trial of weight loss drug

Aug. 22, 2017
By Michael Fitzhugh
Productos Medix S.A. de C.V., a Mexican weight loss specialist leading the most advanced effort to date to get Danish drug developer Saniona AB's first product to market, started a phase III trial of the drug, tesofensine, in obesity. The Medix-funded study is due to finish within two years and could potentially support approval of the triple monoamine reuptake inhibitor as a monotherapy in Mexico, where it's estimated that more than 70 percent of people are overweight and more than 30 percent are clinically obese.
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Alzeca sets sights on early MRI-based Alzheimer's testing with $11M series A

Aug. 21, 2017
By Michael Fitzhugh

Alzeca sets sights on early MRI-based Alzheimer's testing with $11M series A

Aug. 21, 2017
By Michael Fitzhugh
Alzeca Biosciences Inc., a small developer of imaging agents intended to aid early diagnosis of Alzheimer's disease and other neurodegenerative disorders, has closed an $11 million series A financing backed by private investors.
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Opdivo-Yervoy combo shows mixed results in kidney cancer

Aug. 17, 2017
By Michael Fitzhugh
A combination of the Bristol-Myers Squibb Co. checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) diminished the size of previously untreated renal cell carcinomas (RCC) for more people than Pfizer Inc.'s Sutent (sunitinib) during a closely watched phase III trial.
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View All Articles by Michael Fitzhugh

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