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| October 5, 2015
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Article | April 17, 2020
That simple truth about the severity of the disease is one of the reasons that Rafael Pharmaceuticals is slowly continuing with a Phase III trial in metastatic pancreatic cancer during the COVID-19 pandemic. While many companies have paused enrollment in clinical trials during the outbreak, Cranbury, N.J,-based Rafael opted to continue to enroll patients in its Phase III AVENGER 500 study of its lead compound CPI-613 (devimistat) in combination with modified Folfirinox (mFFX) as first-line therapy for the disease. Sanjeev Luther, president and chief executive officer of Rafael Pharmaceuticals, told BioSpace that the company made the decision to continue to enroll the trial, which was 75% filled, due to the short timeline patients with metastatic pancreatic cancer have. After discussing the matter of the trial with the company’s leadership team, Luther said they felt comfortable leaving the decision of whether or not the trial should continue to the conducting institute.
Article | March 6, 2020
Shares of Pfizer jumped more than 6% on Wednesday, after the company announced a plan to test some of its antiviral products as a potential treatment for the coronavirus from China. More than 35 million shares traded on the news — about 48% more than normal — as investors looked for any positive news from the pharma community after the recent selloff. So, does this mean that Pfizer stock is turning the corner?
Article | March 20, 2020
Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).
Article | March 16, 2020
Accelerated by advancements in cancer treatments and a growing emphasis on personalized and precision medicine, specialty pharmacy represents a rapidly growing sector within the healthcare industry. In fact, the market is projected to grow to $500 billion by the end of this year—up from $200 billion in total U.S. specialty drug spending in 2017. Industry growth of this magnitude creates challenges for those looking to understand and penetrate the market. It can be difficult, after all, to maintain updated information about high-priority drug therapy areas or facility affiliations in a market that’s constantly changing.
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