AP: Pepcid as a virus remedy? Trump admin’s $21M gamble fizzled. “….in early April, when government scientists learned of a proposal to spend millions in federal research funding to study Pepcid, they found it laughable, according to interviews, a whistleblower complaint and internal government records obtained by The Associated Press. But that didn’t stop the Trump administration from granting a $21 million emergency contract to researchers trying it out on ailing patients. The Food and Drug Administration gave the clinical trial speedy approval even as a top agency official worried that the proposed daily injections of high doses of famotidine for already sick patients pushed safety ‘to the limits,’ internal government emails show.”
CNN: Study finds hydroxychloroquine may have boosted survival, but other researchers have doubts. “A surprising new study found the controversial antimalarial drug hydroxychloroquine helped patients better survive in the hospital. But the findings, like the federal government’s use of the drug itself, were disputed.”
EurekAlert: Predicting side effects. “A multi-institutional group of researchers led by Harvard Medical School and the Novartis Institutes for BioMedical Research has created an open-source machine learning tool that identifies proteins associated with drug side effects.”
San Francisco Chronicle: UCSF team has discovered drugs that block coronavirus, paving way for ‘a better drug sooner’. “A global team of scientists led by UCSF has discovered a range of existing drugs and experimental compounds that block the new coronavirus in lab tests, revealing some of the virus’ key weaknesses for the first time. Their findings point to possible treatments for COVID-19, according to a paper released Thursday in the journal Nature.”
MIT Technology Review: The race to find a covid-19 drug in the blood of survivors. “In the US, a slow and confused rollout of coronavirus testing helped the new virus get a foothold and cause what is now a raging outbreak. But drug and biotech companies have been searching for a cure since January, when the severity of the epidemic in China became evident. Among the most promising candidates are antibody drugs, a type that already accounts for most of the top-selling medicines in the US.”
PR Newswire: Excelra Releases COVID-19 Drug Repurposing Database to Support Global Drug Development Efforts Against Novel Coronavirus (PRESS RELEASE). “Excelra, a leading global data and analytics company, today announced the release of the COVID-19 Drug Repurposing Database (https://www.excelra.com/covid-19-drug-repurposing-database/). The ‘open-access’ database presents a compilation of ‘previously approved’ small molecules and biologics with known preclinical, pharmacokinetic, pharmacodynamic, and toxicity profiles that can rapidly enter either Phase 2 or 3 clinical trials on fast track basis for COVID-19. In addition, the database also includes information on promising drug candidates that are in various ‘clinical, pre-clinical and experimental’ stages of drug discovery and development for COVID-19.”
Regulatory Focus: FDA Launches Searchable Purple Book. “The US Food and Drug Administration (FDA) on Monday unveiled the first version of its searchable online database of biological product information, known as the Purple Book. Building off the previous PDF lists of biological products, the database now allows for easier searches and includes information on product names (proprietary and proper), the type of biologics license application (BLA) that was submitted, strength of the biologic, dosage form, product presentation, license status, BLA number and approval date.” I didn’t know how a “biological product” was defined. I got educated via this FDA PDF.
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). “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. “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. “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. “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. “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 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.”
Scientific American: Culture Shock: Precious Microbe Collections Languish in Threatened Bio-Libraries. “Freeze-dried and locked away in liquid nitrogen–filled vaults around the world are hundreds of thousands of microbial cultures. In the U.S. these living libraries include 91,000 bacterial and fungal strains in Peoria, Ill., as well as 13,000 fungal strains in Ithaca, N.Y., and 7,500 wild yeasts at the University of California, Davis. Researchers have used strains from such publicly accessible culture collections to develop penicillin as well as the CRISPR gene-editing systems and the PCR (polymerase chain reaction) DNA-amplifying technique. But as government priorities apparently change, and as the federal money that historically created and preserved many of these biological resource repositories in the U.S. dries up, their infrastructure is at risk of deteriorating. “