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BioWorld - Thursday, January 1, 2026
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

CSL invests in key cardiovascular trial, option to buy transplant drug developer

Dec. 6, 2017
By Michael Fitzhugh
Australia's CSL Ltd. said it expects to spend between $450 million and $550 million on its largest-ever study, a phase III trial of CSL-112, an I.V. infusion formulation of human apolipoprotein A-I intended to reduce early recurrent cardiovascular events in heart attack survivors. Separately, the company paid $15 million up front to spark a collaboration and purchase option agreement with Canada's Vitaeris Inc. Together, the companies will work to expedite the development of clazakizumab, an anti-IL-6 monoclonal antibody, as a therapy for solid organ transplant rejection.
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Semma raises $114M to advance cell therapy for diabetes

Dec. 4, 2017
By Michael Fitzhugh
Semma Therapeutics Inc. has raised $114 million in a series B financing aimed at carrying its stem cell-derived beta cells, a potential therapy for people living with type 1 diabetes, through proof-of-concept studies. The company is preparing to file an investigational new drug (IND) application for the program while also exploring additional applications for its technologies.
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Medco's infectious disease business sells to Melinta for $270M

Nov. 30, 2017
By Michael Fitzhugh

True to a pledge to sell its infectious disease (ID) business before year-end in service of its cardiovascular care ambitions, The Medicines Co. has struck a deal with Melinta Therapeutics Inc., a growing infectious disease player. Melinta, which is paying $215 million in cash, plus $55 million in common stock for the business, will gain three marketed antibiotics in the deal, poising it to gain "strategic scale" and to "focus on multiple valuable segments of the anti-infectives market simultaneously," said President and CEO Dan Wechsler.


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Cinrx snags $10M series B to back gastrointestinal-focused pipeline

Nov. 29, 2017
By Michael Fitzhugh
Cincinnati-based Cinrx Pharma LLC, a company advancing four early stage candidates for gastrointestinal, cardiovascular and dermatologic indications, has completed a $10 million series B financing backed by both current and new investors. The company, led in part by a roster of former executives of Teva Pharmaceutical Industries Ltd., expects to file investigational new drug applications for all four candidates in the first half of 2018.
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Biogen adopts late-stage Alkermes MS drug in $228M deal

Nov. 28, 2017
By Michael Fitzhugh
Biogen Inc. is snapping up global rights to Alkermes plc's phase III ALKS-8700, a prodrug of the active metabolite in Tecfidera (dimethyl fumarate), for $28 million up front, potential milestone payments of up to $200 million, and royalties. The experimental multiple sclerosis (MS) drug is expected to be the subject of a 505(b)(2) application in 2018 and may offer more favorable gastrointestinal (GI) tolerability than Tecfidera.
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Cytokinetics sees tirasemtiv hopes dashed in phase III ALS trial miss

Nov. 22, 2017
By Michael Fitzhugh
Cytokinetics Inc. is suspending development of its lead candidate, tirasemtiv, for amyotrophic lateral sclerosis (ALS) after it failed to hit both primary and secondary endpoints in a crucial phase III test.
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Peptidream pull persuades Bayer to ink $1.11B licensing deal

Nov. 21, 2017
By Michael Fitzhugh

Bayer AG is betting up to $1.11 billion (¥124.5 billion) that Peptidream Inc.'s popular therapeutic peptide discovery platform will help it discover novel lead structures in areas such as cancer and cardiology.


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Peptidream pull persuades Bayer to ink $1.11B licensing deal

Nov. 21, 2017
By Michael Fitzhugh
Bayer AG is betting up to $1.11 billion (¥124.5 billion) that Peptidream Inc.'s popular therapeutic peptide discovery platform will help it discover novel lead structures in areas such as cancer and cardiology.
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Egalet sees positive top-line data in phase III oxycodone trial

Nov. 20, 2017
By Michael Fitzhugh
An open-label phase III study of Egalet Corp.'s abuse-deterrent, extended-release oxycodone, Egalet-002, found the drug to be generally well tolerated by about 150 opioid-experienced patients with moderate-to-severe chronic non-cancer pain. The candidate incorporates the company's proprietary Guardian Technology, first deployed in its already-approved Arymo ER (morphine sulfate) product, to make the tablets difficult to manipulate for misuse.
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Deerfield backs Johns Hopkins-based Bluefield Innovations with $65M investment

Nov. 17, 2017
By Michael Fitzhugh
Little more than a month after pledging $50 million to back drug discovery efforts at the Broad Institute of MIT and Harvard, health care investment firm Deerfield Management is funding the creation of a new translational-focused venture at Johns Hopkins University.
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