WELCOME TO The PHARMACEUTICAL REPORT
2nd pharmacovigilance 2016
| July 12, 2016
Symogen Ltd. is a leading pharmacovigilance, pharmacoepidemiology, medical writing and regulatory affairs service provider to the pharmaceutical industry with offices in the UK, USA and India.
Article | April 11, 2020
Rene Roach fired off a quick email in late March for an update on a colorectal cancer clinical trial for which she hoped to qualify. Worried about the coronavirus, she asked, almost as an afterthought, whether the study had been put on hold because of the pandemic.The answer crushed her: It had been. "That's when COVID-19 shut down everything," says Roach, 50, of Germantown, Md. Roach assumed that there would be workarounds for patients like her, who have stage IV cancer. These patients often depend on clinical trials as their best chance to knock cancer out when other therapies have failed. For now, she's being treated with traditional chemotherapy, but she was counting on the drug cocktail from the clinical trial. She figures if chemo was going to rid her body of cancer for good, it would have done so already.
One minor side effect of the pandemic is that perhaps more people will learn about what drug research and clinical trials can really be like. Today’s example: we have a clinical trial of hydroxychloroquine from Wuhan that has just published on a preprint server. What’s good is that this one is blinded, randomized, and controlled (like the earlier hydroxychloroquine which one I blogged about here from Zhejiang University, so we can actually talk about it rather than just spend all our time wondering what the heck is going on.
Pharmaceutical manufacturers are constantly working to develop new and improved medications. Join us as we explore the non-specialty drugs you should be watching in 2020. If you missed last week’s article about the most important upcoming specialty drugs, be sure to check it out here. Approximately 40 new medications are approved by the Food and Drug Administration (FDA) every year.1 (Please note: If you’re curious about what it takes to develop a drug and bring it to market, check out our previous article). Why should you care about these new medications? Because they can affect both your organization’s pharmacy spend and your members’ cost share. For non-specialty drugs, we will focus on medications that may come to market this year, including ones that are currently being reviewed by the FDA, or that are in the last clinical trial (Phase III) stage.
The president and some of his close advisors — desperate for a COVID-19 cure — are asking “What do you have to lose?” by taking hydroxychloroquine (HCQ), a strong medication never adequately tested for efficacy or safety in COVID-19 patients. The correct answer to the president’s question, which he doesn’t seem to want to hear, is that we have our lives to lose. The president acknowledges “I’m not a doctor” but this raises the question “What do doctors know about the drug recommended by the president? Most doctors are aware that HCQ can be effective for patients with malaria, arthritis or lupus. If they were to follow the president’s suggestion and prescribe it for COVID-19 patients, they would also like to know that it will benefit some of those patients, at least.
Keep me plugged in with the best
Join thousands of your peers and receive our weekly newsletter with the latest news, industry events, customer insights, and market intelligence.
Put your news, events, company, and promotional content in front of thousands of your peers and potential customers.
Not a member yet? Not a problem, Sign Up
Sign up to contribute and publish your news, events, brand, and content with the community for FREE