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Safe and effective vaccines represent the most effective way to restore the health and economic security disrupted by the Covid-19 pandemic. To help achieve that goal, the U.S. government launched Operation Warp Speed...to accelerate development and manufacturing of several Covid-19 vaccines, with a goal of having 300 million doses available to the U.S. population by January 2021...Operation Warp Speed is expediting vaccine development primarily by moving clinical trials forward without pauses between phases, and by scaling up manufacturing capacity before knowing if a candidate works...Covid-19 vaccines can help stop the pandemic only if people trust them and want to be vaccinated. To earn and keep the trust of the American people, our government needs to ensure three key needs are met before launching any immunization campaign...READ MORE

• Ensure transparency and confidence in FDA decisions
• Ensure robust active safety monitoring as Covid-19 vaccines are rolled out
• Ensure the distribution and administration of Covid-19 vaccines are equitable and well-executed

Safety net hospitals that participate in the 340B drug discount program generated $64.3 billion in total benefits to community programs and services tailored to help low-income patient populations, a new analysis finds...The analysis, published...from the American Hospital Association, comes as hospitals wage a war with drug companies that have begun restricting sales of discounted products to 340B contract pharmacies. AHA charges the 340B program enables safety net hospitals to help patients in vulnerable communities, but drug companies argue the program has gotten too large and hospitals are not helping patients with the savings...READ MORE

Shortages of vital generic drugs—particularly since the start of the coronavirus disease 2019 pandemic in the US—are well known by pharmacy teams in both health systems and community settings...although pharmacy associations appreciate the Trump administration’s efforts to move more pharmaceutical and active pharmaceutical ingredient manufacturing to the United States...they say government initiatives must include an overall plan for drug pricing, payment model, and supply chain transparency...READ MORE

Changing methods can be tough—that's why Amgen is sticking with its rat poison of choice...With a bill passed this week, California legislators and environmentalists cast a spotlight on the use of industrial rodent poisons that are killing off native wildlife. But local drugmaker Amgen wanted fewer restrictions on its rat-killing methods, leaving critics to suggest: Maybe try traps, instead?...Amgen finagled its way out of the bill—AB 1788, which passed the California Assembly earlier this week—which would have required the company to rethink its rat policy at a facility in Newbury Park. The complex backs up to a wildlife preserve frequented by cougars and other wildlife, according to the Acorn...In an emailed statement, Amgen said it worked to secure the exemption because it simply couldn't identify another method for sending rats to meet their maker—or one would meet the FDA's standard, at least...READ MORE

Biosimilars, which offer the potential for more treatment options and less expensive alternatives, are having a good year in 2020 and may have a significant impact on the prescription product market in 2021. With the approval of more biosimilar medications, experts hope that greater competition may occur and help lower overall costs. “As intellectual property protections for biological products continue to expire in the US, we can expect many more applications for potential biosimilar and interchangeable products, and increased uptake of approved products too,”...Some of the key issues affecting biosimilar uptake involve reimbursement factors and insurance coverage...However...business and intellectual property concerns also have contributed to the delayed launch of some FDA-approved biosimilars. ...READ MORE

Unlike drugmakers that make their meds in-house, a cottage industry of repackagers exists to resell premade drugs with shiny new labels. But what happens when one of those companies fails at its primary job: safely repackaging drugs?...California-based Calvin Scott & Co., a wholesaler specializing in drug repackaging, failed to adequately address quality issues at its New Mexico plant that may have compromised the listed expiration date on one of its drugs, according to a warning letter posted online this week...FDA investigators found that Calvin Scott used suspect heat-sealed pouches to package its version of hydrochlorothiazide...Investigators also found Calvin Scott had inadequate cleaning procedures in place, which led to its drug products sharing multiple surfaces and potentially being cross-contaminated...READ MORE

Researchers at Karolinska Institutet in Sweden have identified a small neutralizing antibody, a so-called nanobody, that has the capacity to block SARS-CoV-2 from entering human cells. The researchers believe this nanobody has the potential to be developed as an antiviral treatment against COVID-19...READ MORE

After touting a series of executive orders on drug pricing in late July, President Donald Trump has now unveiled the most significant among them—an order tying Medicare's drug prices to much lower costs in other developed countries. The biopharma industry pushed back hard, and it’s unclear exactly when or how the changes would be implemented...The executive order...says Medicare should not buy certain Part B or Part D drugs unless at prices paid by “at a minimum, the lowest price at which the manufacturer sells that drug to any other developed nation.” In Part D, the plan would apply “where insufficient competition exists” and where “seniors are faced with prices" higher than those in other developed nations...READ MORE

Access to medicines and cures should be the priority – the focus – for America right now, not unnecessary complications over trade with the Chinese...If one nation shuts down the production of a good, it impacts the supply for the whole world. With drugs, the U.S. gets many ingredients from China and if the Chinese shut off access to these materials, American patients will suffer...The Chinese are using the threat of withholding necessary drug ingredients if trade obstacles with the U.S. supervene...The Chinese are trying to link the Huawei telecom controversy to the drug issue...if the U.S hurts China by continuing current restrictions on Huawei’s access to American technology, they would answer with the withholding of Rx drugs...READ MORE

A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom...A spokesperson for AstraZeneca, a front-runner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.”...READ MORE