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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Nonprofits seek new financing via priority review vouchers

July 5, 2016
By Michael Fitzhugh
With funding from the world's largest source of global health initiatives, the U.S., barely growing and global health development funding stagnant at around $36.4 billion annually, it has become increasingly clear to some that the time for creativity in funding public health programs is now.
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Ampio seeking nod for osteoarthritis, despite failed Ampion 'PIVOT'al trial

July 1, 2016
By Michael Fitzhugh

Ampio Pharmaceuticals Inc. missed the primary endpoint in its second pivotal trial for Ampion, a candidate for treating osteoarthritis of the of the knee (OAK), tested under an FDA special protocol assessment (SPA).


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Merck strikes cancer vaccines deal with Moderna, delivering $200M up front

June 30, 2016
By Michael Fitzhugh
Cancer vaccines tailored to fit tumor-specific profiles are at the heart of a new strategic collaboration and licensing deal between Merck & Co. Inc. and Moderna Therapeutics Inc., a company on which Merck is upping its bet as early clinical data begins to roll in as part of an earlier deal between the two targeting infectious disease.
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Gilead captures approval for pan-genotypic HCV therapy

June 29, 2016
By Michael Fitzhugh
Gilead Sciences Inc. landed an on-schedule FDA approval for the chronic hepatitis C virus (HCV) drug Epclusa, the first drug effective against all six major genotypes of the virus. The fixed-dose combination tablet contains both the active ingredient of Sovaldi (sofosbuvir) and the new NS5A inhibitor velpatasvir.
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Regulus retreads jaundice scare, triggering clinical hold

June 29, 2016
By Michael Fitzhugh
A serious new case of jaundice that developed during a Regulus Therapeutics Inc. study of RG-101 for the treatment of chronic hepatitis C virus (HCV) triggered the FDA to issue a verbal clinical hold on the program, sending company shares (NASDAQ:RGLS) down 49.3 percent to $2.54 on Tuesday.
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Medicines advances antibiotic combo with pivotal phase III data

June 28, 2016
By Michael Fitzhugh
A potential new tool in the war on gram-negative pathogens, The Medicines Co.’s Carbavance (meropenem-vaborbactam) met both FDA and EMA primary endpoints in a pivotal phase III trial testing the therapy in patients with complicated urinary tract infections (cUTIs).
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Jardiance CV death risk vote nears for FDA advisors

June 27, 2016
By Michael Fitzhugh
FDA reviewers told agency advisors in briefing docs released Friday that Jardiance (empagliflozin) postmarket data show "substantial evidence" that, for certain adults with type 2 diabetes, the drug reduces the risk of cardiovascular death. They did not recommend that the advisors support label claims that the drug could reduce the risk of either hospitalization for heart failure (HF) or a composite of CV death (excluding fatal stroke) or hospitalization for HF.
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Academics heed the call for new antibiotics, but find reception mixed

June 23, 2016
By Michael Fitzhugh

IFM Therapeutics raises $27M series A for immune modulators

June 23, 2016
By Michael Fitzhugh
IFM Therapeutics Inc. closed a $27 million series A financing led by Atlas Venture and Abingworth, with participation from Novartis AG. The Cambridge, Mass.-based company, incubated at Atlas, will use the financing to advance and expand its early stage portfolio of preclinical small-molecule modulators.
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Academics heed the call for new antibiotics, but find reception mixed

June 23, 2016
By Michael Fitzhugh
Academia's role in antibiotic development – crucial since the dawn of the antibiotic age when Oxford University purified penicillin ahead of mass production – remains just as important today. Despite the centrality of pioneering work undertaken at universities, challenges from basic training to funding crunches have left a yawning gap in some areas, contributing to a complex web of problems slowing the arrival of new antibiotics on the market.
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