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.
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).
A public offering worth $130 million will extend Rigel Pharmaceuticals Inc.'s cash runway through potential approval of its lead product, fostamatinib.
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).
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.
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.
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.
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.
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.
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.
