- Purdue Pharma Seeks Court OK to Develop New Injectable Opioid Rescue Drug (fdanews.com)
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
- HHS Unveils Strategy to Reduce EHR Burden for Clinicians (healthleadersmedia.com)
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
- Leaders from 24 companies in pharma supply chain working on MediLedger DSCSA Pilot Project (chaindrugreview.com)
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
- NCPA Warns FTC, DOJ that Vertical Mergers have Created Mega-Companies that Shrink Patient Access and Trample Smaller Competitors (ncpanet.org)
The surge in vertical integration in the healthcare industry has created "an oligopoly of integrated healthcare companies controlling nearly all aspects of the healthcare and pharmacy supply chain," said the National Community Pharmacists Association in comments submitted today to the Federal Trade Commission and the US Department of Justice Antitrust Division..."These vertical mergers have allowed a handful of massive companies to exercise enormous power over patients and the marketplace. In many cases, we believe they are creating for themselves unfair advantages that are driving up patient costs and killing local businesses," said B. Douglas Hoey, NCPA CEO...READ MORE
- Chinese heparin maker tried to sneak proof of its unapproved APIs out the back door (fiercepharma.com)
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
- On Your Side: How hard is it to access to rural healthcare in Nevada? (mynews4.com)Health Care Access and Affordability Are Top Issues in Nevada (kunr.org)
In general, the number of licensed health care professionals is drastically lower in rural and frontier counties in Nevada than compared to the urban areas...With a shortage of health professionals across the state, it’s hard enough to find a doctor in Nevada. However, in many rural areas of the state it’s nearly impossible...Rural residents make up 10% of the state's population but live across 90% of the state's land mass. With smaller communities spread across large distances, getting access to proper healthcare can be difficult...The issues in getting healthcare in rural Nevada boil down to three things: workforce, money, and resources...READ MORE
- This Week in Managed Care: February 21, 2020 (ajmc.com)
Christina Mattina, welcome to This Week in Managed Care from the Managed Markets News Network
- US begins first study of coronavirus treatment, testing Gilead’s remdesivir (flickr.com)Gilead commits to in-house development of coronavirus treatment hopeful (biopharmadive.com)Hong Kong plans $15 billion spending to support its economy amid coronavirus outbreak (cnbc.com)Coronavirus (nytimes.com)Coronavirus COVID-19 Global Cases by Johns Hopkins CSSE (gisanddata.maps.arcgis.com)
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
- 3D printing is focus of Aprecia-Purdue partnership (chaindrugreview.com)
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
- February 21 Week in Review (pharmacytimes.com)
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.