- China turns Roche arthritis drug Actemra against COVID-19 in new treatment guidelines (fiercepharma.com)
Some patients infected with the novel coronavirus can develop uncontrolled immune response, leading to potentially life-threatening damage to lung tissue. After seeing promising results in clinical practice, Chinese authorities now recommend a Roche arthritis drug to tackle that rampage...Roche’s blockbuster Actemra, first approved by the U.S. FDA in 2010 for rheumatoid arthritis, can now be used to treat serious coronavirus patients with lung damage, China’s National Health Commission said in its updated treatment guidelines for COVID-19...READ MORE
- FDA Outlines Plan for Requesting Records from Chinese Drugmakers (fdanews.com)
FDA Commissioner Stephen Hahn offered more details of the agency’s plans to request paper records from Chinese drugmakers and API manufacturers while inspections in China are on hold during the COVID-19 outbreak...While FDA inspections are suspended in China, the agency may ask firms for facility records ahead of or instead of inspections, allowing the agency to review records ahead of time and identify plants that most warrant an inspection...“These records will help the agency when we resume drug inspections in China,” allowing it to focus early inspections and help prevent an inspection backlog, he said...READ MORE
- First patient in Nevada tests presumptively positive for novel coronavirus, is in ‘airborne isolation’ (thenevadaindependent.com)
A Clark County man who is in his 50s and has an underlying health condition is the first patient in Nevada who has tested presumptively positive for the novel coronavirus...The determination made Wednesday evening stems from a test the health authority performed on the man, who is currently hospitalized and in “airborne isolation,” and a sample is being sent to the Centers for Disease Control and Prevention for official confirmation...VA spokesman Charles Ramey said in an email that the man who tested presumptively positive for the disease is a veteran inpatient at the VA Southern Nevada Healthcare System...Health authorities said the patient reported traveling recently to Washington State, where the virus has been widely spreading...READ MORE
- International guidelines on how pharmacists should deal with the latest coronavirus outbreak issued by FIP (fip.org)FIP HEALTH ADVISORY CORONA VIRUS SARS-CoV-2 OUTBREAK: Information and interim guidelines for pharmacists and the pharmacy workforce (fip.org)
The roles that pharmacists in community, hospital and clinical biology can play in preventing the spread of the new coronavirus 2019-nCoV and supporting the efficient management of infection by healthcare systems are outlined in a new document published by the International Pharmaceutical Federation (FIP) today. The document was developed by an emergency taskforce set up by FIP following the World Health Organization’s declaration that the outbreak of 2019-nCoV constitutes a public health emergency of international concern...READ MORE
- Indian export group says European industry ‘panicking’ over APIs (in-pharmatechnologist.com)Indian government shuts down export of certain APIs due to coronavirus (in-pharmatechnologist.com)
After the Indian government moved to limit the export of APIs, an Indian export association says fear is spreading amongst European businesses over supply...The news broke...that the Indian government had decided that the export of 26 active pharmaceutical ingredients and formulations would be placed under restriction...As a result, Dinesh Dua, chairman of the Pharmaceuticals Export Promotion Council of India, told Reuters, that European industry was ‘panicking’...“I am getting a huge number of calls from Europe because it is very sizeably dependent on Indian formulations and we control almost 26% of the European formulations in the generic space.”...READ MORE
- This Week in Managed Care: March 6, 2020 (ajmc.com)
Christina Mattina, welcome to This Week in Managed Care from the Managed Markets News Network
- The Virus and the Supply Chain (city-journal.org)
The new coronavirus outbreak may be very bad for your health but not only for the reasons you imagined. This coronavirus is less likely to harm you directly than to injure you through its impact on your other medical needs...COVID-19 is more likely to harm Americans indirectly because the U.S. is increasingly reliant on drugs either directly sourced from China or made from intermediate chemicals...While 90 percent of the finished drugs Americans take are generics, most are manufactured overseas, primarily in India and China. Even India...relies on China for 80 percent of the APIs it uses in drug production...COVID-19 has resulted in massive disruption of Chinese manufacturing. It’s only a matter of time until this translates into supply disruptions for China-dependent customers...Coronavirus has created concerns about not only the quantity of Chinese medical products available but also about the virus’s effect on quality. China does not effectively regulate Chinese drug manufacturers. Multiple episodes have cast doubt on the safety and efficacy of their products...READ MORE
- What Pharmacies Are Doing to Mitigate Shortages Due to COVID-19 (drugtopics.com)
Chain pharmacies and US government agencies are doing everything they can to mitigate shortages of facemasks, hand sanitizers, and other products as consumers rush to purchase supplies due to coronavirus...fears..."The extreme demand in some areas certainly is affecting supplies," Chris Krese, spokesperson for NACDS, told Drug Topics®...Meanwhile, the FDA announced the first drug shortage due to COVID-19, but declined to list the drug in shortage...This information is considered proprietary...hand sanitizers and facemasks have been virtually stripped from store shelves, and that Amazon, Walmart, and other retailers’ web sites are running out of affordable hand sanitizers..."Due to high demand and to support all customers, we will be limiting the number of sanitization, cold and flu-related products to 5 each per order," Kroger said on its website...READ MORE
- March 6 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.
- Coronavirus spurs India to restrict exports of 2 dozen drugs (fiercepharma.com)India's restrictions on API exports only temporary, official says: report (fiercepharma.com)
While eyes have been on China for signs that COVID-19 might result in drug shortages, India has come up with a surprise of its own. The country, which accounts for about 40% of U.S. generic drugs, has halted exports of more than two dozen APIs and drugs...India’s Directorate General of Foreign Trade today announced it was restricting 26 APIs and formulations until further notice...The government gave no further explanation, but Dinesh Dua, chairman of the Pharmaceuticals Export Promotion Council of India, told Reuters, “Irrespective of the ban, some of these molecules may face shortages for the next couple of months.” If interruptions from the virus get worse, he said, some shortages may become “acute.”...READ MORE