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BioWorld - Monday, December 22, 2025
Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Teva give-back puts cell-based heart failure therapy in Mesoblast's hands

June 22, 2016
By Michael Fitzhugh
Mesoblast Ltd. lost more than a third of its market value last week as Teva Pharmaceutical Industries Ltd. returned full development and commercialization rights to its advanced chronic heart failure therapy, MPC-150-IM. Mesoblast CEO Silviu Itescu sought to cast the return as "a major win" for the company, simultaneously announcing a equity financing facility that will fund the program through completion.
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Blade lands $45M series B to hack fibrotic disease

June 17, 2016
By Michael Fitzhugh
Blade Therapeutics Inc. closed a $45 million series B financing to advance the screening, selection and development of lead molecules designed to modify the pathobiology of fibrotic diseases.
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Allecra gets $24.7M to carry antibiotic through phase II

June 16, 2016
By Michael Fitzhugh
Antibiotic developer Allecra Therapeutics GmbH has raised €22 million (US$24.7 million) in a series B round to fully fund phase II trials for AAI202, a combination of a beta-lactam antibiotic together with a proprietary, extended-spectrum beta-lactamase inhibitor designed to treat gram-negative multidrug-resistant bacterial infections.
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Teva give-back puts cell-based heart failure therapy in Mesoblast's hands

June 15, 2016
By Michael Fitzhugh
Mesoblast Ltd. lost more than a third of its market value Tuesday (NASDAQ:MESO) as Teva Pharmaceutical Industries Ltd. returned full development and commercialization rights to its advanced chronic heart failure therapy, MPC-150-IM. Mesoblast CEO Silviu Itescu sought to cast the return as "a major win" for the company, simultaneously announcing a equity financing facility that will fund the program through completion.
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Paxvax wins FDA approval for U.S. cholera vaccine

June 14, 2016
By Michael Fitzhugh
Paxvax Inc. has gained FDA approval for Vaxchora, the only cholera vaccine to be approved in the U.S. The approval comes with a valuable tropical disease priority review voucher that CEO Nima Farzan told BioWorld Today the company is likely to sell.
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Sophiris wows Street with prostate cancer data

June 13, 2016
By Michael Fitzhugh
Sophiris Bio Inc.'s shares (NASDAQ:SPHS) rose 69.2 percent to a $1.98 close on Friday after publishing data showing that a single injection of PRX302 (topsalysin) durably destroyed localized prostate cancer tumor cells in half of the 18 men enrolled in an open-label phase IIa study.
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March on antimicrobial resistance is gaining coordination

June 9, 2016
By Michael Fitzhugh
SAN FRANCISCO – Antimicrobial resistance, an agenda item gaining urgency and attention on the world stage, also gathered further attention at the BIO International Convention on Wednesday, where policy thinkers joined industry representatives in praising the recent publication of the U.K.-driven final Review on Antimicrobial Resistance (AMR).
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Biogen shares weighed down by 'complex' top-line phase II results

June 8, 2016
By Michael Fitzhugh
Biogen Inc. shares (NASDAQ:BIIB) sank 12.8 percent to close at $252.86 on Tuesday after the company said that opicinumab missed both the primary and secondary efficacy endpoints in the phase II study Synergy, which evaluated the candidate as a therapy for people with relapsing forms of multiple sclerosis (MS). Despite the miss, the company said, "evidence of a clinical effect with a complex, unexpected dose-response was observed."
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FDA's Califf speaks to patient engagement, off-label communications

June 8, 2016
By Michael Fitzhugh
SAN FRANCISCO – With "the age of authoritarian medicine" fast giving way to an era of consumer-driven health care, patients are more often "involved from the beginning" in defining what happens at the FDA, Commissioner Robert Califf told attendees at the BIO International Convention. The latitude drugmakers have to do so remains fuzzier.
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Barriers to value-based drug pricing still abound

June 8, 2016
By Michael Fitzhugh
SAN FRANCISCO – America's journey into the tricky landscape of value-based health care, pioneered by hospitals and insurers, continues to beckon drugmakers to get onboard. But logistical difficulties and open questions around who benefits from the approach are slowing its march, panelists said during a session on the subject at the BIO International Convention.
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