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ENDOZYME II GO recombinant Factor C assay: fast, easy andconsistent endotoxin testing
GREGORY DEVULDER | April 24, 2019
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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.
The global antiviral drugs market has witnessed a rapid surge in demand due to the ongoing Covid-19 pandemic worldwide. So is antiviral drug the best coronavirus treatment? It is still too early to have that conclusion as many medical research and clinical trials are still trying to find the effectiveness and potential side effects of using antiviral drugs to treat coronavirus. But experts believe that antiviral drug might be the best hope for reduce the coronavirus transmission around the world at this stage. However, due to the current difficult situation of the supply chain in many lockdown countries and regions, there is a global shortage on the antiviral drugs supply. With researchers and manufacturers working hard to find and provide effective coronavirus treatment, it is expected that the global antiviral drugs market will have a significant growth over the near future. Antiviral drugs are a type of medication used specifically for treating viral infections, such as human immunodeficiency virus (HIV), hepatitis, and influenza.
We go into a doctor’s office and leave with a diagnosis and a prescription. Next we stop by the pharmacy. In Germany, if your insurance is not private, you mostly don’t even know the price of your drug because it’s paid for directly by your insurance. You only notice the 5-10 Euros copay. But how is a drug priced in Germany? And (how) does data play a role in helping pharma secure an attractive price point? Let’s fast forward directly to the launch of a new drug. At the time of launch, the pharmaceutical company has to present patient level evidence of the drug’s added value compared to existing comparative therapies. In the first year, however, the drug’s price can be defined freely by the company.
Over the past half-century, clinical trials have grown increasingly complex. A flood of new data from novel sources combined with more elaborate study designs and tougher regulatory standards have lengthened timelines and hiked costs, contributing to a steady decline of efficiency. It all adds up: Nearly half of all drug launches underperform revenue expectations. And if that isn’t enough, the outbreak of COVID-19 worldwide is having an effect on how life sciences companies operate their businesses, including how clinical trials are conducted. Most clinical trial research organizations have tried to adapt by tweaking a platform here, adding a new app there, but this has only yielded patchwork systems of sites, spreadsheets and dashboards that further burden the process.
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