Gateway Analytical Teams up with Researchers from the FDA/CDER/Division of Pharmaceutical Analysis to Present at RDD 2014

| February 13, 2014

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Gateway Analytical has teamed up with researchers from the Division of Pharmaceutical Analysis at FDA/CDER to present new findings on temperature-mediated agglomeration assessment in Orally Inhaled and Nasal Drug Products.

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Enobia Pharma

Enobia develops therapies to treat serious genetic bone disorders for which there are no approved treatments. Our lead product in development, ENB-0040 (human recombinant tissue non-specific alkaline phosphatase), is a subcutaneous bone-targeted enzyme replacement therapy for the rare disease hyposphostasia.

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Clinical Development Risks and Issues in a COVID-19 World

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).

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How pharma can continue engaging HCPs in a world gripped by COVID-19

Article | April 10, 2020

Medscape is the leading source of clinical news, health information, and point-of-care tools for healthcare professionals. Medscape offers specialists, primary care physicians, and other health professionals the most robust and integrated medical information and educational tools. Medscape Education (medscape.org) is the leading destination for continuous professional development, consisting of more than 30 specialty-focused destinations offering thousands of free CME and CE courses and other educational programmes for physicians, nurses, and other healthcare professionals. Both Medscape and Medscape Education are part of WebMD Health Corp., an Internet Brands company. Face-to-face interactions between pharma and physicians have essentially ceased overnight during the COVID-19 pandemic, but that doesn’t mean HCPs have stopped looking for new medical information.

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Coronavirus Pandemic Brings Hundreds Of U.S. Clinical Trials To A Halt

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.

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What to Watch in 2020: Non-Specialty Drugs

Article | March 1, 2020

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.

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Spotlight

Enobia Pharma

Enobia develops therapies to treat serious genetic bone disorders for which there are no approved treatments. Our lead product in development, ENB-0040 (human recombinant tissue non-specific alkaline phosphatase), is a subcutaneous bone-targeted enzyme replacement therapy for the rare disease hyposphostasia.

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