Science: FDA and NIH let clinical trial sponsors keep results secret and break the law

Science: FDA and NIH let clinical trial sponsors keep results secret and break the law. “Science examined more than 4700 trials whose results should have been posted on the NIH website ClinicalTrials.gov under the 2017 rule. Reporting rates by most large pharmaceutical companies and some universities have improved sharply, but performance by many other trial sponsors—including, ironically, NIH itself—was lackluster. Those sponsors, typically either the institution conducting a trial or its funder, must deposit results and other data within 1 year of completing a trial. But of 184 sponsor organizations with at least five trials due as of 25 September 2019, 30 companies, universities, or medical centers never met a single deadline.”

BusinessWire: Kramer Levin Launches Biologics Law Blog (PRESS RELEASE)

BusinessWire: Kramer Levin Launches Biologics Law Blog (PRESS RELEASE). “Kramer Levin Naftalis & Frankel LLP today launched the Bio Law Blog, which provides insights into intellectual property law and regulatory developments for biologic medicines. The blog is edited by Kramer Levin partners Irena Royzman, Ph.D., Jonathan S. Caplan and Hannah Lee.” I wasn’t sure what “biologic medicine” was, but MedicineNet helped me out.

Chemistry World: Open access Atlas maps out microbial natural products

Chemistry World: Open access Atlas maps out microbial natural products. “A new open access database of microbial natural products has launched online. The Natural Products Atlas (NPAtlas) is free to use and contains more than 24,000 chemical structures. The tool is based on Fair data principles, making the information within it easier to search and use in secondary analysis.” I don’t put anything in RB unless I can get a basic understanding of what the resource is about. (I have skipped including items because I just didn’t get the underlying discipline or presentation.) In this case I had no idea what microbial natural products are, but I now understand better thanks to PubMed.

MIT Technology Review: AI is reinventing the way we invent

MIT Technology Review: AI is reinventing the way we invent. “Regina Barzilay’s office at MIT affords a clear view of the Novartis Institutes for Biomedical Research. Amgen’s drug discovery group is a few blocks beyond that. Until recently, Barzilay, one of the world’s leading researchers in artificial intelligence, hadn’t given much thought to these nearby buildings full of chemists and biologists. But as AI and machine learning began to perform ever more impressive feats in image recognition and language comprehension, she began to wonder: could it also transform the task of finding new drugs?”

Pacific Standard: A New Website Shows Nearly Half Of E.U. Clinical Trial Data Isn’t Publicly Disclosed

Pacific Standard: A New Website Shows Nearly Half Of E.U. Clinical Trial Data Isn’t Publicly Disclosed. “Three researchers created a website earlier this year to name and shame pharmaceutical companies and universities in the United States that break a law that activists say is critical to patient safety. Now, the three have joined a few others to do the same for the European Union, creating a website that names 3,755 clinical trials—studies, done with human volunteers, of the safety and efficacy of new prescription drugs, vaccines, and medical devices—that have passed their deadlines for posting results publicly to the E.U. Clinical Trials Register.”

NPR: How Social Media Can Reveal Overlooked Drug Reactions

NPR: How Social Media Can Reveal Overlooked Drug Reactions. “When Allison Ruddick was diagnosed with stage 3 colorectal cancer in October 2014, she turned to the world of hashtags. After her initial diagnosis it wasn’t clear if the cancer had metastasized, so she was in for a nerve-wracking wait, she says. She wanted outside advice. ‘But they don’t really give you a handbook, so you search kind of anywhere for answers,’ Ruddick says. ‘Social media was one of the first places I went.’ Under the hashtags #colorectalcancer and #nevertooyoung on Facebook, Twitter and Instagram, other patients were sharing a fuller picture of their experience with cancer treatments.”

FDA: FDA Widens Scope of Navigator – Information Tool for Expanded Access

FDA: FDA Widens Scope of Navigator – Information Tool for Expanded Access. “FDA is committed to expanding access to safe and effective treatment options for patients with rare, debilitating, and sometimes fatal diseases. These patients face unique medical challenges. Sometimes there isn’t an FDA-approved drug to adequately address the needs of a patient with a rare disease. Therefore, the agency needs to take new steps to enable more patients with unmet needs to get access to promising treatments prior to full FDA approval. Two examples of the recent steps FDA has taken in pursuit of these goals are improvements we made to our Expanded Access Program and our Orphan Drug Program.”