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Opioid makers and distributors who proposed paying almost $50 billion to resolve U.S. lawsuits over the addictive drugs are drawing more support from states, including California and New York, as pressure mounts for a deal before a trial starts next month...But nearly two dozen states and most of the cities and counties suing to hold the industry responsible for the havoc and high costs of the opioid epidemic say the terms still aren’t good enough...READ MORE

Two clinical trials testing potential treatments for the new coronavirus spreading from China are getting underway in Nebraska and Washington, marking a step forward in the U.S. efforts to find a therapy or vaccine for the pneumonia-like illness caused by the virus...The trial, which is designed to expand to include new centers and experimental drugs over time, will test first remdesivir, an antiviral originally developed by Gilead for use against the Ebola virus. Experts view the drug as among the more promising existing therapies for potential use against the new coronavirus, now called SARS-CoV-2...READ MORE

Health care is poised for a potential giant leap forward thanks to the 3D printing of medications. To advance the technology and science of 3D pharmaceutical printing, Purdue University’s College of Pharmacy and Aprecia Pharmaceuticals are launching a comprehensive collaboration on future 3DP pharmaceutical equipment and medications…READ MORE

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Purdue Pharma has requested permission from the U.S. Bankruptcy Court for the Southern District of New York to develop a new product to reverse opioid overdoses...Purdue is seeking authorization for a development agreement between its affiliate, Greenfield Bioventures, and an unnamed pharmaceutical company. The proposed agreement would allow Purdue to grant intellectual property related to the nalmefene injectable to its unnamed partner, which in turn, would license its autoinjector technology to Purdue...READ MORE

The federal government has released its long-awaited plan to reduce red tape and other administration snarls that create time-eating obstacles for doctors using health information technology...The Department of Health and Human Services' Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs, mandated by the 21st Century Cures Act, aims to reduce the effort and time required by clinicians to meet reporting requirements, record health information, and improve the functionality and intuitiveness of EHRs...READ MORE

At the beginning of 2019, ...the…Food and Drug Administration began accepting pilot project proposals to identify solutions for meeting the 2023 requirements of the Drug Supply Chain and Security Act. The…Congress passed the DSCSA to improve the security of the pharmaceutical supply chain to help eliminate counterfeit pharmaceuticals and enhance patient safety...the MediLedger Project, a working group of 24 industry leading pharmaceutical manufacturers, distributors, retail chains, logistics partners and solution providers, was accepted by the FDA as one of their approved proposals…The working group’s purpose was to evaluate blockchain technology…in the track and trace of prescription medicines in the United States. The MediLedger Project released…the MediLedger DSCSA Pilot Project Final Report detailing how and why blockchain can meet the 2023 DSCSA requirements for an interoperable, confidential change of ownership system in the US pharmaceutical supply chain…READ MORE

On arrival for a pre-approval inspection for a Chinese heparin API maker, an FDA inspector was told that the plant had not started making products and was only doing equipment testing. The truth of the matter was hidden in a drum being snuck out the back. An intercepted container an employee was removing from the warehouse contained two batches of crude heparin manufactured two days earlier...That was just the beginning of the problems found during July 2019 inspection of Yibin Lihao Bio-technical, the API maker in Yibin Shi Sichuan, China. According to a warning letter, there were quality assurance records scattered in cabinets, on desks and on the floor of the QA office. Employees insisted they were for a grant application from the government and not manufactured products. Not true. The FDA would learn the records did correspond to manufactured heparin...READ MORE

Over the past few decades, very few new antibiotics have been developed, and most of those newly approved antibiotics are slightly different variants of existing drugs. Current methods for screening new antibiotics are often prohibitively costly, require a significant time investment, and are usually limited to a narrow spectrum of chemical diversity…In this case, the researchers designed their model to look for chemical features that make molecules effective at killing E. coli… This molecule…halicin…The researchers…found that it was able to kill many that are resistant to treatment, including Clostridium difficile, Acinetobacter baumannii, and Mycobacterium tuberculosis…“This groundbreaking work signifies a paradigm shift in antibiotic discovery and indeed in drug discovery more generally,”…READ MORE

Christina Mattina, welcome to This Week in Managed Care from the Managed Markets News Network