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As part of the administration’s campaign to reduce the United States’ reliance on an increasingly global pharmaceutical supply chain and to minimize potential shortages for critical drugs, FDA has published a list of those drugs and medical products considered critical for addressing public health emergencies. The list will provide a basis for bolstering biopharmaceutical production at home of essential medicines and medical products and for addressing supply chain vulnerabilities...READ MORE

Washington, Oregon and Nevada will join California to independently review any coronavirus vaccine before distributing it to the public...Gov. Gavin Newsom said Tuesday that the three states would identify their own public health experts to participate in the scientific review committee he announced last week, which was charged with ensuring that any vaccine approved by the U.S. Food and Drug Administration is safe and effective...California has also formed a second committee to develop guidelines for the ethical distribution of vaccines, Newsom said, addressing questions about who should receive the first doses and how to allocate potentially limited supplies...READ MORE

The Trump administration announced it will cover a vaccine for COVID-19 at no cost to Medicare beneficiaries...The Centers for Medicare & Medicaid Services released an interim rule on Wednesday that aims to remove regulatory barriers for seniors to get the vaccine, which is expected to be approved by early next year...READ MORE

As the leading COVID-19 vaccines move closer to potential emergency use, the research and regulatory processes have been intensely scrutinized. But there’s one area that hasn’t seen as much attention so far—manufacturing facility inspections...COVID-19 vaccine developers seeking FDA emergency use authorizations won’t have to undergo pre-approval site inspections...The FDA conducts thousands of facility inspections per year, and some find flaws that drug or vaccine companies must remedy before launching new products...READ MORE

Deaths after flu vaccination keep rising in South Korea. But as local health authorities work to calm concerned citizens by refuting a connection between the two, a fellow Asian country has taken the precautionary measure of suspending two shots given to people who later died...Singapore has temporarily pulled its backing for SK Bioscience’s SKYCellflu Quadrivalent and Sanofi Pasteur’s VaxigripTetra, the Ministry of Health said...READ MORE

...the FBI and two federal agencies said they had credible information of “an increased and imminent cybercrime threat” to U.S. hospitals and health care providers. The alert said malicious groups are targeting the sector with attacks aiming for “data theft and disruption of healthcare services.”...It involves a particular strain of ransomware, which scrambles a target’s data into gibberish until they pay up. Previous such attacks on health care facilities have impeded care and, in one case in Germany, led to the death of a patient..Independent security experts say the ransomware, called Ryuk, has already impacted at least five U.S. hospitals this week and could potentially affect hundreds more. Four health care institutions have been reported hit by ransomware so far this week, three belonging to the St. Lawrence Health System in upstate New York and the Sky Lakes Medical Center in Klamath Falls, Oregon...READ MORE

Walmart has filed suit against the United States Department of Justice and the Drug Enforcement Administration, asking a US District Court judge to clarify the roles and responsibilities of pharmacists and pharmacies under the Controlled Substances Act...Although Walmart’s pharmacies have blocked “thousands” of questionable physicians from having their opioids scripts filled by its pharmacists, “certain DOJ officials have long seemed more focused on chasing headlines than fixing the crisis,” the retailer said. “They are now threatening a completely unjustified lawsuit against Walmart, claiming in hindsight pharmacists should have refused to fill otherwise valid opioid prescriptions that were written by the very doctors that the federal government still approves to write prescriptions.”...READ MORE

Japanese drugmaker Takeda has quickly emerged as one of the leading forces in the fight against COVID-19 as a vaccine manufacturing partner and R&D lead on a convalescent plasma-based therapy. Now, Takeda will help another biotech distribute its potential COVID-19 vaccine in the drugmaker's home country...Moderna has tapped Takeda to bring 50 million doses of its mRNA-based COVID-19 shots to Japanese shores as part of a government-backed vaccine distribution effort...Takeda will import and distribute Moderna's shot, dubbed mRNA-1273, starting in the first half of next year, as well as handle local regulatory approvals...READ MORE

Needs in the European Region in order for pharmacy to deliver breakthroughs for better primary health care are described in a new report...The report summarises the key messages from a conference for the European Region, held by FIP in collaboration the Turkish Pharmacists’ Association in 2019, which facilitated mapping and prioritisation of pharmaceutical practice, service, education and workforce development needs in the context of primary health care. At that conference, pharmacy leaders and pharmacists representing 37 countries in the region committed to deliver better primary health care through pharmacy, and the report presents findings of a survey of FIP member organisations conducted between June and September 2020 to evaluate national pharmacy priorities and strategies towards the implementation of that commitment...READ MORE

The most pressing healthcare, health workforce and pharmaceutical education needs in sub-Saharan Africa are described in a report published...by FIP, alongside recommendations towards achieving universal health coverage. The new report, “FIP pharmacy education in sub-Saharan Africa”, documents the outcomes of the FIP-UNESCO UNITWIN Global Pharmacy Education Development Network, launched in 2010 to advance research, training and curriculum development in pharmacy education by building university networks and encouraging inter-university cooperation worldwide...READ MORE