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Home » Authors » Michael Fitzhugh

Articles by Michael Fitzhugh

Isis investors find hope in positive phase II diabetes data

May 15, 2014
By Michael Fitzhugh
Isis Pharmaceuticals Inc. shares (NASDAQ:ISIS) extended a slow recovery Wednesday as investors took note of phase II data showing that the company's experimental antisense drug, ISIS-GCGRRx, helped patients with type 2 diabetes improve control of the disease, even when they're unable to do so with metformin.
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Mabvax going public through Telik merger

May 14, 2014
By Michael Fitzhugh
Mabvax Therapeutics Inc., a privately held cancer immunotherapy company, is taking the fast lane to Nasdaq through a merger with publicly traded Telik Inc., which will fade out in the deal's wake.
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Tesaro shares climb as nausea drug hits phase III endpoints

May 13, 2014
By Michael Fitzhugh
Investors drove Tesaro Inc. shares up 21 percent Monday (NASDAQ:TSRO) on news that the company hit both its primary and secondary endpoints in a phase III trial of rolapitant, its top hope for breaking into the $1.5 billion U.S. market for drugs preventing chemotherapy-induced nausea and vomiting (CINV).
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A-T, G-C . . . and more? Synthorx launched on new DNA base pair tech

May 9, 2014
By Michael Fitzhugh
Synthorx Inc., a new synthetic biology company backed by Avalon and Correlation Ventures, is leveraging exclusive rights to a technology for creating synthetic DNA base pairs to improve the discovery and development of new medicines, diagnostics and vaccines.
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Partnering returned assets can rescue, maximize value

May 8, 2014
By Michael Fitzhugh
Deal terminations can throw even the most confident companies for a loop, dealing a blow to the perceived value of even still-promising assets. Finding a new partner saves the day, but it takes careful strategic planning, according to panelists at the recent Allicense 2014 meeting in San Francisco.
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Merck files BLA for anti-PD-1 immunotherapy

May 7, 2014
By Michael Fitzhugh
Merck & Co. Inc. on Tuesday completed filing its FDA biologics license application for MK-3475 (pembrolizumab), its high-profile programmed cell death 1 (PD-1) inhibitor. The company is seeking approval to treat melanoma patients unsuccessfully treated with Yervoy (ipilimumab, Bristol-Myers Squibb Co.), an indication for which the FDA has granted it both breakthrough designation and priority review status.
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FDA denies Eisai, UCB efforts to tweak exclusivity timing

May 6, 2014
By Michael Fitzhugh
The FDA has denied citizen's petitions filed by Eisai Inc. and UCB Inc. to change how the agency sets the five-year exclusivity clock for new chemical entities (NCEs) that require Controlled Substances Act (CSA) scheduling, stating that the approach the petitioners suggested is unworkable under current regulations.
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Rxi Pharmaceuticals sees clear upside for RNAi therapeutic

May 5, 2014
By Michael Fitzhugh
Investors drove shares in Rxi Pharmaceuticals Corp. (NASDAQ:RXII) up as high as $4.30 Friday after the company reported that intravitreal injection of RXI-109, its experimental RNA interference-based therapy, reduced connective tissue growth factor (CTFG) protein levels in an animal study, showing its potential to fight retinal and corneal scarring as a result of injury or disease.
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Second Genome inks microbiome deal with Pfizer

May 2, 2014
By Michael Fitzhugh
Second Genome Inc. is partnering with Pfizer Inc. on a large observational study exploring the relationship between the trillions of microorganisms comprising the human microbiome and obesity and metabolic disorders.
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New funding avenues bridge the gap for some early stage biotechs

May 1, 2014
By Michael Fitzhugh
SAN FRANCISCO – The once-predictable financing pathway for early stage biotech companies, from venture rounds to exit, is getting a creative makeover as players with more nuanced goals and strategies step into the fray.
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