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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

BACE1cally kaput? Merck stops Alzheimer's study for lack of efficacy

Feb. 16, 2017
By Michael Fitzhugh
Merck & Co. Inc. is calling a halt to a high-profile phase II/III study of verubecestat after data monitors found "virtually no chance of finding a positive clinical effect" for patients with mild to moderate Alzheimer's disease.
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Gilead, Janssen showcase HIV advances at CROI

Feb. 15, 2017
By Michael Fitzhugh
Gilead Sciences Inc., pressured by declining sales in its hepatitis C franchise and slower than anticipated growth in its HIV line-up, is putting its best foot forward at the Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle this week.
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Zosano Pharma reports pivotal trial win for migraine patch Zotrip

Feb. 14, 2017
By Michael Fitzhugh
Zosano Pharma Corp.'s migraine-targeting zolmitriptan-coated microneedle patch, M207, met both co-primary endpoints of the company's pivotal phase III Zotrip trial, delivering freedom from pain at two hours for 41.5 percent of treated patients and relieving the most bothersome symptom for a majority of those treated at the same time point.
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TRC105 fails to extend Avastin's PFS benefit in glioblastoma study

Feb. 13, 2017
By Michael Fitzhugh
Tracon Pharmaceuticals Inc. reported that adding its lead candidate, TRC105 (carotuximab), to Avastin (bevacizumab) didn't appear to help patients with recurrent glioblastoma enjoy any more time without a worsening of their condition than Avastin monotherapy does.
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Academics propose path to undercut sky-high cancer drug costs

Feb. 10, 2017
By Michael Fitzhugh
Leaders at four academic drug centers have proposed that colleagues battle high cancer drug prices by resisting the temptation to sell promising candidates to the highest bidder. Instead, they advocate for enlisting generic and biosimilar drugmakers to produce de-risked candidates governed by price-capping agreements.
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Amgen overcomes CRL to win U.S. approval for Parsabiv

Feb. 9, 2017
By Michael Fitzhugh
Six months later than first expected, FDA approval for Amgen Inc.'s secondary hyperparathyroidism (SHPT) treatment, Parsabiv (etelcalcetide), has arrived.
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First patient dosed in Advaxis’ phase III cervical cancer trial

Feb. 7, 2017
By Michael Fitzhugh
A phase III trial testing the ability of Advaxis Inc.’s lead immunotherapy candidate, axalimogene filolisbac, to improve disease-free survival among patients with high-risk locally advanced cervical cancer has enrolled and dosed its first patient. The FDA fast-tracked study, called AIM2CERV, is expected to enroll 450 patients and is being run under a special protocol assessment.
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Amgen buoyed on Repatha cardiovascular data, positive fourth-quarter earnings

Feb. 6, 2017
By Michael Fitzhugh
Estimate-beating fourth-quarter earnings for Amgen Inc. pushed company shares about $7.95 higher to close at $167.53 on Friday as sales of its cholesterol treatment Repatha (evolocumab) rose and a closely watched phase III trial suggested that combining the antibody with optimized statin treatment could reduce the risk of heart attack and other CV events in patients with arterial plaque buildups.
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Mustang Bio saddles up with $94.5M private placement

Feb. 3, 2017
By Michael Fitzhugh
Fortress Biotech Inc. subsidiary Mustang Bio Inc. closed on a $94.5 million private placement financing. It plans to use the funds to advance its two lead chimeric antigen receptor T-cell (CAR T) immunotherapies, MB-101 and MB-102, through phase I data readouts early next year and to grow its pipeline by exploring additional applications for its CAR T technology beyond its initial focus in brain cancer and acute myeloid leukemia.
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MoveDMD trial miss crushes Catabasis shares

Feb. 2, 2017
By Michael Fitzhugh

Catabasis Pharmaceuticals Inc. (NASDAQ:CATB) shares tumbled 70.7 percent lower to $1.18 by Wednesday's market close as top-line data from a proof-of-concept trial of its Duchenne muscular dystrophy (DMD) candidate edasalonexent (CAT-1004) showed that 12 weeks of treatment with the NF-kB inhibitor failed to significantly impact a biomarker indicative of benefits in lower leg muscle composition and inflammation in boys with the fatal condition.

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