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Several high-profile U.S. Food and Drug Administration officials are resigning from their positions within the federal agency in protest of the Biden administration’s overreach when it comes to COVID-19-related scientific decisions such as booster shots...Despite the lack of clear evidence in support of booster shots, the Biden administration plans to move forward with supplemental jabs for adults beginning as early as the White House’s Sept. 20 deadline, pending the FDA’s approval. This pressure from the Democrat president and his administration to offer “premature and unnecessary” consent to something that scientific data does not conclusively back up, reports indicate, is causing strife within the regulatory agency...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

A new study from Accenture shows a boomerang back to a familiar topic—drug costs...“We asked what would increase trust in the pharmaceutical industry, and for many people there’s a clear link between cost and trust,”...The top two answers specifically pointed to reduced medication costs (41%) and more transparency in pricing (39%) as measures that would make the respondents trust pharma companies more...An earlier Accenture report from May suggested the new economic reality for pharma meant companies would have to work at changing the cost narrative with customers. It suggests focusing on value and outcome-based pricing to build trust...READ MORE

Drug-overdose deaths in the U.S. surged nearly 30% in 2020, the tragic result of a deadlier supply and the destabilizing effects of the Covid-19 pandemic, according to preliminary federal data and public health officials...The estimated 93,331 deaths from drug overdoses last year, a record high, represent the sharpest annual increase in at least three decades, and compare with an estimated toll of 72,151 deaths in 2019, according to provisional overdose-drug data released...by the Centers for Disease Control and Prevention...READ MORE

Horse dewormer falsely believed to treat COVID-19 in short supply in Reno...Deworming season is fast approaching for horse owners in Northern Nevada. Every September through November, horses are administered medications containing ivermectin to stave off life-threatening parasitic intestinal worms...But this year, feed stores are having a difficult time keeping large-animal ivermectin medications on the shelves due to a spike in interest in the drug's use as a home remedy for COVID-19...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

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

“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

The New York Times reports that the Pfizer shot will be the first of the coronavirus jabs to be cleared by the FDA...According to the report, the FDA originally had planned to approve the vaccine before Labor Day, but decided to accelerate its ruling...The full approval of the shot also paves the way for employers and private companies to mandate employees and patrons to be vaccinated...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