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BioWorld - Friday, January 30, 2026
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Amgen sues to block competing PCSK9 drug from Sanofi/Regeneron

Oct. 20, 2014
By Michael Fitzhugh
Amgen Inc. is throwing a wrench in the gears advancing Sanofi SA's and Regeneron Pharmaceuticals Inc.'s high cholesterol drug alirocumab, seeking an injunction to block the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor's manufacture and sale over alleged infringement on patents protecting Amgen's own anti-PCSK9 therapy, evolocumab, now under regulatory review.
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J&J pledges up to $817M for Aduro cancer therapies

Oct. 17, 2014
By Michael Fitzhugh
Johnson & Johnson unit Janssen Biotech Inc. is committing $30 million up front, plus up to $787 million in milestones to Aduro Biotech Inc. for an exclusive global license to a lung cancer treatment based on Aduro's Listeria-based immunotherapy platform.
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Selecta bags new equity funding, extended Sanofi support

Oct. 16, 2014
By Michael Fitzhugh
Selecta Biosciences Inc. Wednesday said it raised more than $20 million in equity funding from new and existing investors to advance its lead program, the severe gout drug SEL-212, and its early stage pipeline of antigen-specific immune therapies.
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Into the fray: NIH offers grantees tools to succeed in business

Oct. 13, 2014
By Michael Fitzhugh
Scientists committed to making a successful leap from lab to market are getting a leg up from a unique NIH pilot program teaching a relatively new model of entrepreneurship, that of the lean start-up.
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FDA approves Gilead's HCV combo, Harvoni; offers eight-week treatment potential

Oct. 13, 2014
By Michael Fitzhugh
Gilead Sciences Inc. won FDA approval to market Harvoni, the first oral therapy for people with genotype 1 hepatitis C virus (HCV) to eliminate the need for both interferon and ribavirin.
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Arrowhead analysts cite 'overreaction'; shares wilt on HBV trial news

Oct. 10, 2014
By Michael Fitzhugh
Arrowhead Research Corp.'s shares (NASDAQ:ARWR) regained little ground Thursday after hitting a 52-week low at midweek as investors sold off shares over concern about the potential performance and timing of the company's experimental RNAi-based chronic hepatitis B (HBV) therapy,
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Strong year sets the stage for BIO Investor Forum

Oct. 7, 2014
By Michael Fitzhugh
SAN FRANCISCO – While the fall heat wave here peaked Saturday, the sizzle clearly remains. More than 650 attendees are registered for this week's two-day Biotechnology Industry Organization (BIO) Investor Forum in the City by the Bay, lining up a record 1,200 partnering meetings in the wake of a year in which, so far, public and private biotech companies have raised a collective $25 billion.
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Dermira's upsized IPO raises $125M for underserved market

Oct. 6, 2014
By Michael Fitzhugh
Dermira Inc. raised about $125 million in an upsized initial public offering (IPO) Friday, selling 7.8 million shares (NASDAQ:DERM) at a top-of-range $16 each. The skin treatment developer, which is leveraging UCB Pharma SA's tumor necrosis factor-alpha inhibitor Cimzia (certolizumab pegol) to lead its charge into the underserved dermatology market, closed down 3.4 percent, or 54 cents, at $15.46.
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Calithera shares meet a humble start as Dermira and Forward set ranges

Oct. 3, 2014
By Michael Fitzhugh
Calithera Biosciences Inc.'s shares (NASDAQ:CALA) closed Thursday at $9.41, a loss of 59 cents, after rising as much as 12.4 percent to $11.24 after the tumor metabolism and immunology specialist priced its initial public offering (IPO).
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Portola's factor Xa inhibitor antidote puts brakes on bleeding

Oct. 2, 2014
By Michael Fitzhugh
Portola Pharmaceuticals Inc.'s shares (NASDAQ:PTLA) rose 16 percent higher Wednesday, climbing $4.04 to close at $29.32, after the company shared top-line data from the first of two planned phase III studies showing that andexanet alfa, its universal factor Xa inhibitor antidote, met its primary and secondary endpoints.
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