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BioWorld - Monday, December 29, 2025
Home » Authors » Catherine Shaffer

Articles by Catherine Shaffer

Antibiotic Returned to Anacor; GSK Discontinues Development

Oct. 8, 2012
By Catherine Shaffer
Eight months after suspending Phase I/II trials of Anacor Pharmaceuticals Inc.'s systemic antibiotic, GSK2251052, GlaxoSmithKline plc has dropped the other shoe by discontinuing development of the compound.
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Aragon's Series D Adds $50M To Advance ARN-509 in CRPC

Oct. 5, 2012
By Catherine Shaffer
Aragon Pharmaceuticals Inc. parlayed its successful Phase II results in prostate cancer to a new financing round worth $50 million supported by existing investors and led by new investor venBio. The funds will support advancement of ARN-509 in castration-resistant prostate cancer (CRPC).
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Banking on Fostamatinib, Rigel Seeks to Raise $130M

Oct. 4, 2012
By Catherine Shaffer
A public offering worth $130 million will extend Rigel Pharmaceuticals Inc.'s cash runway through potential approval of its lead product, fostamatinib.
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ArQule Tumbles on Survival Miss in Lung Cancer Study

Oct. 3, 2012
By Catherine Shaffer
Shares of ArQule Inc., of Woburn, Mass., plummeted 56.3 percent Tuesday following news that an independent data safety monitoring committee had terminated its Phase III MARQUEE trial of ARQ 197 in nonsquamous non-small-cell lung cancer (NSCLC).
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Santarus' Uceris Beats Asacol, Placebo in Ulcerative Colitis

Sep. 28, 2012
By Catherine Shaffer
Results from the CORE I trial of Uceris (budesonide) in ulcerative colitis appeared in Gastroenterology, detailing a statistically significant benefit over placebo for inducing remission of the disease.
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Clarity for Cardiome as Merck Returns Rights to Vernakalant

Sep. 27, 2012
By Catherine Shaffer
Six months of uncertainty have come to an end for Cardiome Pharma Corp., as Merck & Co. Inc. announced it would hand global marketing and development rights for I.V. and oral formulations of heart drug vernakalant back to the Vancouver, British Columbia-based company.


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Shutdown Avoided but Drug User Fee Impact is Unclear

Sep. 24, 2012
By Catherine Shaffer
In a last-minute vote before leaving for a five-week vacation legislators funded the federal government, avoiding a shutdown. But the resolution may lack amendments that would have prevented new user fees from being enacted. Congress passed a partial fix on Sept. 19.
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FDA User Fees at Risk in Senate Budget Vote

Sep. 21, 2012
By Catherine Shaffer
The senate is preparing to vote on a Continuing Resolution that will fund the federal government from Oct. 1, 2012, through March 31, 2013, by limiting all agencies to monies received in fiscal year 2012. As reasonable as that sounds, the resolution could have a disproportionately large affect on the FDA, because it omits language that would have allowed the FDA to collect user fees provided for in FDASIA for 2013.
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FDA Adcom: 'No Limits' on New Tumor Cell Lines in Vaccines

Sep. 20, 2012
By Catherine Shaffer
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) found no red flags preventing the use of new tumorigenic cell lines for vaccine production, but had plenty of questions and hypotheticals for the experts gathered at Wednesday's meeting.
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Committee to Ponder Tumor Cells for Vaccine Manufacture

Sep. 18, 2012
By Catherine Shaffer
The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) released briefing documents in advance of its Wednesday meeting to discuss the use of cell lines derived from human tumors for vaccine manufacture.
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