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.

The Verge: 23andMe sold the rights to a drug it developed from its genetic database

The Verge: 23andMe sold the rights to a drug it developed from its genetic database. “The genetics testing company 23andMe licensed the rights to a drug it developed in-house to a Spanish pharmaceutical company, Bloomberg reported. This is the first time that the company has directly sold a product it created using the genetic information collected from users.”

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.

NoCamels: Scientists Harness AI, Deep Learning To Fast-Track Drug Discovery And Development

NoCamels: Scientists Harness AI, Deep Learning To Fast-Track Drug Discovery And Development. “The cost of developing a new pharmaceutical drug, from the research and development stage to market approval, runs at about $2.6 billion, according to a 2014 report published by the Tufts Center for the Study of Drug Development (CSDD) cited by the Scientific American. It also takes between 10 to 15 years. Israeli scientists say they have developed a revolutionary smart method to discover and develop new drugs, based on artificial intelligence and machine learning, that will dramatically shorten preparation time and reduce costs.”

Revitalizing the drug pipeline: AntibioticDB, an open access database to aid antibacterial research and development (Journal of Antimicrobial Chemotherapy)

Journal of Antimicrobial Chemotherapy: Revitalizing the drug pipeline: AntibioticDB, an open access database to aid antibacterial research and development. “The current state of antibiotic discovery, research and development is insufficient to respond to the need for new treatments for drug-resistant bacterial infections. The process has changed over the last decade, with most new agents that are in Phases 1–3, or recently approved, having been discovered in small- and medium-sized enterprises or academia. These agents have then been licensed or sold to large companies for further development with the goal of taking them to market. However, early drug discovery and development, including the possibility of developing previously discontinued agents, would benefit from a database of antibacterial compounds for scrutiny by the developers. This article describes the first free, open-access searchable database of antibacterial compounds, including discontinued agents, drugs under pre-clinical development and those in clinical trials: AntibioticDB.” The article is free.

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.”