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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

...Purdue Pharma has signed a massive settlement to walk away from federal civil and criminal charges. But as the company wades throught court-supervised bankruptcy, will the government—or individuals hurt by Purdue's bad behavior—see anywhere close to that amount in damages?...Purdue has reached an $8 billion-plus deal with the U.S. Department of Justice to plead guilty and settle federal criminal and civil claims for its role in fueling the nation's opioid epidemic...Purdue has been assessed a $3.54 billion criminal penalty and will forfeit an additional $2 billion, the government said. The company has also agreed to pay $2.8 billion to settle the government's civil claims. In addition, the company's founding Sackler family will forfeit $225 million in civil damages...READ MORE

Fast progress has spurred hopes that several vaccines could succeed, spurring jockeying among governments to secure supplies...Scientists, drugmakers and governments are moving with unprecedented haste to develop a vaccine against the new coronavirus...The fastest of them have already delivered promising data from initial human studies, and further results from larger tests should come quickly over the next three to six months...The goal...is to have a vaccine ready for use in some fashion by the end of the year, or early next. Doing so would be a scientific feat with few parallels. No vaccine has ever been developed so quickly, never mind manufactured for the world...READ MORE

Hospitals and health systems are building and expanding their own specialty pharmacies, and with good reason, according to several veterans of specialty rollouts...more than 75% of hospitals with at least 600 beds operate a specialty pharmacy, allowing them to directly prescribe patients critical medications for various chronic and often life-threatening diseases...An in-house specialty pharmacy provides many financial and clinical advantages over external specialty pharmacies for both patients and providers...significant roadblocks, and time and effort needed, to successfully launch a specialty pharmacy...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

Following a rapid course of development and testing, Gilead Sciences Inc. has secured the first and only FDA approval for a COVID-19 treatment, the antiviral Veklury (remdesivir). Previously authorized only for emergency use (EUA) in the U.S., the drug can now be prescribed to adults and children 12 and older weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization...READ MORE

A California panel of experts will independently review the safety of new coronavirus vaccines and initial plans for distribution, Governor Gavin Newsom said...The 11-person panel specializing in topics such as epidemiology, biostatistics, and infectious disease will review any vaccine approved by the Food and Drug Administration before it is distributed to state residents, Newsom told a news conference...The U.S. government’s efforts to speed development of a COVID-19 vaccine - and promises by U.S. President Donald Trump that one could be available prior to the Nov. 3 presidential election - has led to concerns of political interference in the regulatory process at the expense of safety. The FDA has vowed to ensure the safety of COVID-19 vaccines before approving them...READ MORE

Despite multiple published guidelines and antimicrobial stewardship programs, inappropriate antibiotic prescribing persists. Can simple behavioral “nudges”—including low-hanging fruit such as tip sheets and posters, as well as default-choice restriction of microbiology lab reports to a list of selected antimicrobials—steer providers in the appropriate direction, thus reducing both the inappropriate use of antibiotics and antibiotic resistance?...READ MORE

CVS Health is pushing for pharmacy technicians to be allowed to administer COVID-19 vaccines...The healthcare giant is hiring more than 10,000 full- and part-time pharmacy technicians in Q4 in anticipation of flu season, and urging for them to have an expanded scope of practice that would allow them to vaccinate patients for the novel coronavirus under supervision from an immunization-certified pharmacist...CVS said that allowing technicians to administer vaccines would "help fill the urgent need to safely and quickly scale distribution of a vaccine and extend the capacity of the health care workforce to address the pandemic."...READ MORE

Food and Drug Administration advisory committee meetings tend to be staid, albeit important, events typically watched by a few dozen company representatives, scientists, investors and patient advocates...But next week's hearing on coronavirus vaccine studies will be set against the backdrop of a presidential election 12 days later that could turn on the White House's response to the pandemic, likely making it a closely-watched affair of historic proportions...In the meantime, here are five important questions that could feature at next week's meeting...READ MORE

• How will vaccine safety be monitored following an emergency clearance? After a full approval?
• How long will immunity last and how would it be measured?
• How will vaccine-induced enhanced respiratory disease be monitored?
• Has enough data been collected on vulnerable groups?
• Will future vaccine trials need to measure COVID-19 cases, or will immune response data be enough?