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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

A panel of advisers for the National Institutes of Health was not convinced convalescent plasma should be used to treat COVID-19, a recommendation that appears to conflict with a controversial decision by the Food and Drug Administration last week to issue an emergency authorization for the blood-derived treatment...The panel...reviewed the same data cited by the FDA, but concluded it to be "insufficient" to recommend "either for or against the use of convalescent plasma for the treatment of COVID-19."...the same panel cautioned against using hydroxychloroquine in treating coronavirus disease three weeks after the FDA cleared emergency use of the malaria pill...READ MORE

The Centers for Disease Control and Prevention released new data last week that depicts how many Americans who have died from COVID-19 also had other contributing conditions...According to the report, only 6% of deaths have COVID-19 as the only cause mentioned, revealing that 94% of patients who died from coronavirus also had other “health conditions and contributing causes.”...The CDC explains that their data uses provisional death counts to “deliver the most complete and accurate picture of lives lost to COVID-19.”...These numbers are based on death certificates, which the organization says are the most reliable source of data. Death certificates reportedly contain information that is not available anywhere else and includes comorbid conditions, race and ethnicity, and place of death...The CDC says provisional death counts may not match counts from other sources, such as numbers from county health departments, because death certificates take time to be completed, states report at different rates, it takes officials extra time to code COVID-19 deaths, and because other reporting systems use different definitions or methods for counting deaths...The organization adds that provisional data is not yet complete, provisional counts are not final and are subject to change, and that death counts should not be compared across states...READ MORE

California is poised to become the first state to develop its own line of generic drugs, targeting soaring drug prices and stepping into a fiercely competitive drug market dominated by deep-pocketed pharmaceutical companies...The Democratic-controlled legislature overwhelmingly approved a measure...that would direct the state’s top health agency to partner with one or more drug companies by January to make or distribute a broad range of generic or biosimilar drugs — including the diabetes medicine insulin — that are cheaper than brand-name products...The bill, SB-852, also opens the door for California to make its own generic drugs in the future...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

The Food and Drug Administration is concerned that generics giant Mylan has deep-rooted problems in its global manufacturing network, with the latest evidence coming from a site in India...The agency posted this week a warning letter about Mylan's Unit 7 facility, which makes dozens of active pharmaceutical ingredients, or APIs, used in blood pressure drugs, antifungals and central nervous system treatments. During a February inspection, regulators found the site did not have adequate procedures in place to prevent contamination. They noted that similar issues were seen last year at Unit 8..."These repeated failures at multiple sites manufacturing API demonstrate that your company's oversight and control over the manufacture of drugs is inadequate. You should immediately and comprehensively assess your company’s global manufacturing operations,"...READ MORE

Several COVID-19 vaccine developers, including Pfizer Inc, Johnson & Johnson and Moderna Inc, plan to issue a public pledge not to seek government approval until their vaccine candidates are proven to be safe and effective...The companies would pledge to adhere to high scientific and ethical standards in the conduct of clinical studies and in their manufacturing processes, the Journal report here said, citing the draft of a joint statement that is still being finalized...The news comes amid rising concerns that political pressure ahead of the Nov. 3 election could weigh on the safety and effectiveness of a potential vaccine for the respiratory illness...READ MORE

A congressional oversight committee plans to subpoena AbbVie for documents as part of an investigation into drug pricing... The House Oversight and Reform Committee has been seeking documents related to the pricing of AbbVie's top two drugs, which generated more than $23 billion combined last year...Chairwoman Carolyn Maloney, D-N.Y., said the company's responses have been "particularly poor"...AbbVie is the only one to receive a subpoena thus far, with Maloney saying its "noncompliance stands out as particularly egregious." The drugmaker said it was "surprised and disappointed" by the committee's action...READ MORE

Researchers in Costa Rica are due to begin trials of an inexpensive coronavirus treatment based on antibodies taken from horses injected with the SARS-Cov-2, the virus that causes COVID-19...Developed by University of Costa Rica’s Clodomiro Picado Institute, the equine antibodies medication is to be tested on 26 patients from mid-September...Costa Rican authorities hope to be able to begin applying the treatment more widely in hospitals if the results from the phase 2 study are encouraging. There are 471 hospitalized coronavirus patients in Costa Rica...Similar efforts are also underway in Argentina and Brazil, while scientists in Belgium are using llamas...READ MORE

Dozens of major hospitals across the U.S. are grappling with whether to ignore a federal decision allowing broader emergency use of blood plasma from recovered COVID-19 patients to treat the disease in favor of dedicating their resources to a gold-standard clinical trial that could help settle the science for good...As many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial...Officials at some hospitals said they are considering committing only to the clinical trial—and either avoiding or minimizing use of convalescent plasma through an emergency use authorization issued...by the federal Food and Drug Administration...The response comes amid concerns that the Trump administration pressured the FDA into approving broader use of convalescent plasma...A National Institutes of Health panel this week countered the FDA’s decision, saying that the therapy “should not be considered the standard of care for the treatment of patients with COVID-19” and that well-designed trials are needed to determine whether the therapy is helpful. Data so far suggests the treatment could be beneficial, but it’s not definitive...READ MORE