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BioWorld - Wednesday, December 31, 2025
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Internet of things remains a web of challenges

Nov. 11, 2016
By Michael Fitzhugh
HALF MOON BAY, Calif. – The nascent "internet of things," (IoT) an evolving, borderless network of small, sensor-laden devices that is expected to transform at least some aspects of health care and clinical trials, holds great promise but also significant challenges that, for now, continue to stymie some of its potential, panelists at the Techonomy Health Roundtable said Wednesday.
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Curevac tops up with $29.5M financing as prostate cancer trial readout nears

Nov. 9, 2016
By Michael Fitzhugh
Messenger RNA (mRNA) drug developer Curevac AG added $29.5 million in new funds to its coffers from German investors looking to support the Tübingen-based home team in a hot field defined by sizable early investments.
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Innocoll kicks Cogenzia to curb on failed trials, submits Xaracoll NDA

Nov. 7, 2016
By Michael Fitzhugh
The failure of a gentamicin-containing collagen sponge called Cogenzia to deliver statistically significant improvements in clinical cure rates for patients with diabetic foot infections during twin phase III studies sunk shares of Innocoll Holdings plc (NASDAQ:INNL) on Friday, driving them 17.4 percent lower to a $2.89 close after touching a 52-week low.
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Intercept, Alimera, Amarin, Amag and more all lose ground on earnings

Nov. 4, 2016
By Michael Fitzhugh
Shares of Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) fell nearly 16.5 percent to close at $98.20 on Thursday as the company reported third-quarter revenue of $5.2 million, primarily attributed to its biliary cholangitis (PBC) therapy, Ocaliva (obeticholic acid), sales of which narrowly missed analyst expectations. Net losses at the New York-based company totaled $88.8 million vs. about $51 million in the third quarter of 2015, a period before Intercept made the jump to being a commercial company.
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Leo Pharma taps Morphosys to fuel dermatology ambitions

Nov. 3, 2016
By Michael Fitzhugh
Leo Pharma A/S is again raising its bet on the promise of biologics to address important skin diseases, dealing in Morphosys AG and its Ylanthia antibody platform for a multi-target deal. The collaboration could yield multiple new dermatology therapies and milestone payments for Morphosys of up to €111.5 million (US$123.9 million) per program.
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Trade secret thefts often internal

Oct. 31, 2016
By Michael Fitzhugh

Q3 earnings reports weigh on Abbvie and Amgen, keep Biomarin and Seagen steady

Oct. 31, 2016
By Michael Fitzhugh
Worries over slowing global sales of Abbvie Inc.'s largest product, Humira (adalimumab), and fears about the outlook for Amgen Inc.'s Enbrel (etanercept) dimmed the shine on shares of both companies by Friday's close, shaving 6.3 percent from Abbvie shares (NYSE:ABBV) and pushing Amgen shares (NASDAQ:AMGN) shares down 9.6 percent.
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Attorneys counsel at-ready stance on cyber-attacks

Oct. 31, 2016
By Michael Fitzhugh
The rising tide of digital attacks touching politics, finance and retail also poses significant threats for the pharmaceutical and medical device industries. During a Thursday webinar, attorneys at King & Spalding LLP counseled that internal identification of "crown jewel" trade secrets, rigorous protection plans and an at-ready stance for incident response to thefts should form the core of corporate game plans.
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Oncogenex sees bladder cancer benefit in apatorsen

Oct. 27, 2016
By Michael Fitzhugh
Oncogenex Pharmaceuticals Inc. reported that a combination of its lead anticancer candidate apatorsen and the chemotherapy docetaxel met the primary endpoint of overall survival in the investigator-sponsored phase II Borealis-2 trial, reducing the risk of death for metastatic bladder cancer patients who failed initial therapy by 20 percent vs. treatment with docetaxel alone (hazard ratio (HR) of 0.80, 95 percent confidence interval: 0.65-0.98; p = 0.078).
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Sickle cell trial design for GBT440 lifts up Global Blood's shares

Oct. 26, 2016
By Michael Fitzhugh
Global Blood Therapeutics Inc. (GBT) has reached an agreement with the FDA on the design of a pivotal phase III trial for GBT440, the company's experimental once-daily therapy for adults and adolescents with sickle cell disease (SCD).
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