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“You are not a horse. You are not a cow. Seriously, y’all. Stop it.” This is the Food and Drug Administration's recently tweeted advice to Americans seeking out alternative, unapproved treatments for COVID-19...The comment is aimed mainly at Mississippi residents as a follow-up to the state’s official Health Network Alert issued Friday. The Magnolia State has experienced increasing calls to its poison control line, with 70% of the calls related to the ingestion of the livestock formulation of anti-parasitic drug ivermectin...While ivermectin is FDA-approved to treat and prevent parasite infections, the drug commonly found at most local feed stores is highly concentrated for large animals such as horses and cows. In that type of formulation, it can be highly toxic to humans...READ MORE

Stunning reversals, surprise delays and controversial approvals are the order of the day at the FDA lately—and doctors have had enough...Physicians’ trust in the agency is plummeting, according to a recent survey by Spherix Global Insights. More than 40% of the doctors surveyed said their confidence in the FDA has dropped over the past year...Doctors cited a range of problems—including suspected political motivations and lack of transparency...READ MORE

Nevada Air Guard Capt. Caleena Longworth knew at the age of 10 that she wanted to be a doctor, and by January of this year, in the final semester of her medical doctorate program, she was one class away...With the class not set to begin until April, UNLV’s Kirk Kerkorian School of Medicine offered her a two-month vacation. Instead, Longworth, an Air Force veteran and native of Reno, started administering thousands of vaccinations to Nevadans at Cashman Center...READ MORE

South Africa's president said...the "selfish, unjust" refusal of pharmaceutical companies and allied Western governments to entertain emergency patent waivers on COVID-19 vaccines was endangering the entire world...In unusually impassioned remarks, Cyril Ramaphosa lambasted a resistance to calls by India and South Africa for temporary patent waivers to ramp up production...The proposed waiver from the WTO's agreement on Trade-Related Aspects of Intellectual Property Rights has support in principle from U.S. President Joe Biden and French President Emmanuel Macron...But the pharmaceutical industry is against the waiver, as are Germany, Switzerland and the World Bank. They argue it would stifle innovation and that vaccine supplies are constrained by a lack of manufacturing capacity...READ MORE

The U.S. FDA has awarded the first full approval for a COVID-19 vaccine to Pfizer and its German partner BioNTech, a historic decision that comes weeks ahead of its previously expected Labor Day deadline...Pfizer’s jab, now approved for people aged 16 and older, will remain under an emergency nod for adolescents aged 12 to 15...The agency’s full approval for Pfizer’s mRNA shot, now marketed as Comirnaty, is expected to spark a wave of vaccine mandates from companies, universities and organizations awaiting the agency’s final sign-off...READ MORE

Raw materials and limits on high-tech equipment often take center stage when it comes to discussions around manufacturing bottlenecks. But the COVID-19 pandemic has exposed another weak link in the pharmaceutical supply chain: people...As COVID-19 vaccine production moves full-tilt, mRNA players Pfizer and Moderna are having trouble recruiting talent...Hiring challenges, which have been exacerbated by the pandemic, aren’t unique to COVID-19 vaccine makers...READ MORE

The U.S. drug regulator...added a warning to the literature that accompanies Pfizer Inc/BioNTech and Moderna COVID vaccine shots to indicate the rare risk of heart inflammation after its use...For each vaccine, the fact sheets for healthcare providers have been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with onset of symptoms within a few days after vaccination, the FDA said...READ MORE

During the COVID-19 pandemic many hospitals and health care services teams turned to telepharmacy to reduce delays in providing medications to patients while social distancing practices were in place. Hospitals quickly found that telepharmacy benefitted pharmacy services by providing patients with more efficient access to medical care and reducing costs. Thus, hospitals were able to focus more on patient care and less on logistics, which led to higher turnaround times and increased patient satisfaction...READ MORE

The Food and Drug Administration is preparing to announce a new warning for the Johnson & Johnson coronavirus vaccine saying the shot has been linked to a serious but rare side effect called Guillain-Barré syndrome, in which the immune system attacks the nerves...About 100 preliminary reports of Guillain-Barré have been detected after the administration of 12.8 million doses of Johnson & Johnson vaccine in the United States, the Centers for Disease Control and Prevention said in a statement Monday. The cases have largely been reported about two weeks after vaccination and mostly in men, many aged 50 and older...READ MORE

Use of the anti-parasitic drug ivermectin could reduce COVID-19-related deaths, data from a peer-reviewed study shows...The study, published last week in the American Journal of Therapeutics, analyzed data from multiple clinical studies assessing ivermectin as a potential treatment for COVID-19. Ivermectin, which is approved by the U.S. Food and Drug Administration as a treatment for intestinal strongyloidiasis and onchocerciasis...The latest assessment of those multiple studies seems to confirm the potential of ivermectin against COVID-19. However, the FDA currently maintains a web page warning against the unauthorized use of ivermectin to treat the virus...The FDA notes that clinical studies are underway assessing ivermectin against COVID-19, but until those are reviewed and confirmed, it will warn against taking unauthorized medication...READ MORE