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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Lilly looks to Halozyme delivery technology in potential $825M deal

Dec. 22, 2015
By Michael Fitzhugh
Halozyme Therapeutics Inc. added Eli Lilly and Co. to the roster of companies angling to develop products incorporating its Enhanze delivery platform, a potential aid in the dispersion and absorption of its injectables.
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Navitor to further mTORC1 modulators with $33M series B

Dec. 21, 2015
By Michael Fitzhugh
A year and a half after landing a $23.5 million series A financing, Navitor Pharmaceuticals Inc. has attracted new investors to a $33 million series B round intended to help it identify a lead candidate in a pipeline of candidates capable of modulating the mammalian target of rapamycin complex 1 pathway and carrying it into the clinic by early 2018.
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Astrazeneca 'Acerta[s]' its ambitions in blood cancer with $4B deal

Dec. 18, 2015
By Michael Fitzhugh
Astrazeneca plc is buying 55 percent of privately held Acerta Pharma LLC, the developer of acalabrutinib, a phase III oral small-molecule Bruton's tyrosine kinase (BTK) inhibitor that it expects to transform the treatment of B-cell malignancies.
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Array's binimetinib improves PFS for patients with NRAS-mutant melanoma

Dec. 17, 2015
By Michael Fitzhugh
Shares of Array Biopharma Inc. (NASDAQ:ARRY) climbed 20.6 percent to $4.62 on Wednesday following news that its MEK inhibitor, binimetinib, improved progression-free survival (PFS) for patients with advanced NRAS-mutant melanoma compared to chemotherapy during the phase III Nemo study.
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Kallyope lands $44M series A to explore gut-brain axis

Dec. 11, 2015
By Michael Fitzhugh
Kallyope Inc., a New York-based biotech company focused on developing a platform to influence the brain via the gut, has secured its first investment, a $44 million series A financing to explore the untapped therapeutic and nutritional potential of the bidirectional communication channel. From its lab, overlooking the Empire State Building, it expects to develop its own therapeutic programs in parallel with a platform for translating gut-brain biology into a range of new therapeutic and nutritional programs. But it is "not interested in therapeutics that are just incremental," CEO Nancy Thornberry, a veteran of Merck & Co. Inc., told BioWorld Today.
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Teva's reslizumab overcomes adcom concerns to win support

Dec. 10, 2015
By Michael Fitzhugh
Members of the FDA's Pulmonary-Allergy Drugs Advisory Committee (adcom) voiced majority support on Wednesday for the approval of Teva Pharmaceutical Industries Ltd.'s Cinqair (reslizumab) injection for adults with asthma, though they stood firmly against potential use of the drug in children, 12 to 17.
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Gene therapies convince clinicians of promise, unsettle investors

Dec. 8, 2015
By Michael Fitzhugh
ORLANDO, Fla. – New research being presented at the American Society of Hematology (ASH) meeting is adding to growing evidence that experimental gene therapies may improve the health of people with inherited bleeding and immune disorders, as well as some forms of blood cancer, but progress is not as even as investors would like.
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Imbruvica RESONATEs with docs ready for new first-line CLL treatment

Dec. 8, 2015
By Michael Fitzhugh
ORLANDO, Fla. – Treating previously untreated older patients with chronic lymphocytic leukemia (CLL) with Imbruvica (ibrutinib) proved superior to standard of care treatment with the chemotherapy chlorambucil, according to new phase III data presented at the American Society of Hematology meeting and simultaneously published online in The New England Journal of Medicine.
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The right direction: True North raises $40M series C round

Dec. 4, 2015
By Michael Fitzhugh
True North Therapeutics Inc. raised $40 million in series C equity funding to advance development of its lead complement inhibitor, TNT009, through potential registration-enabling studies for cold agglutinin disease (CAD), while also advancing other complement inhibitors in its pipeline.
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Kite begins third study to back registration of lead CAR T-cell program

Dec. 3, 2015
By Michael Fitzhugh
Kite Pharma Inc. is kicking off its ZUMA-3 study, the third in what's soon to be a quartet of pivotal studies aimed at supporting regulatory approval of KTE-C19, its anti-CD19 chimeric antigen receptor (CAR) T-cell therapy and lead candidate.
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