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...federal judge in Texas has denied attempts by the U.S. Food and Drug Administration to conceal data on Pfizer’s COVID-19 vaccine. The judicial rule overturned the regulatory agency’s plan to withhold data for up to 55 years...The ruling follows a lawsuit filed by a nonprofit organization called Public Health and Medical Professionals for Transparency, which was formed to promote transparency of the COVID-19 vaccine data used to secure Emergency Use Authorization. In its lawsuit...the PHMPT claimed that under federal law, the data and information in the biological product file that was submitted to the FDA are expected to be available for public disclosure unless extraordinary circumstances have been shown. The judge presiding over the lawsuit agreed...The judge’s ruling demands that the FDA make the data publicly available within a span of eight months...READ MORE

Holmes faced 11 total counts, and the jury found her guilty of four of them. Each carries a maximum sentence of 20 years in prison...Theranos founder and former chief executive officer Elizabeth Holmes, who once promised "lab on a chip" technology to upend the diagnostics industry...The verdict follows months of testimony, including some from doctors, former Theranos employees and board members, patients, and Holmes herself, about their experiences with the once-vaunted blood-testing startup..."​​Holmes and [former Theranos chief operating officer Ramesh] Balwani used advertisements and solicitations to encourage and induce doctors and patients to use Theranos' blood testing laboratory services, even though, according to the government, the defendants knew Theranos was not capable of consistently producing accurate and reliable results for certain blood tests," read the indictment...READ MORE

Paxlovid and molnupiravir are the first oral treatments for COVID-19, potentially valuable new tools as the fast-spreading omicron variant fuels a sharp surge in cases across the U.S...The Food and Drug Administration...authorized the first pill for COVID-19, clearing for emergency use an antiviral treatment from Pfizer at a precarious moment in the two-year-old pandemic. One day later...the agency cleared a second pill developed by Merck & Co...READ MORE

COVID-19 vaccines from Pfizer and Moderna should be "preferred" over Johnson & Johnson's shot, a U.S. government advisory panel said...after reviewing data on potentially dangerous blood vessel blockages from clotting associated with J&J's vaccine. The recommendation follows a strengthened warning the Food and Drug Administration added to the shot...The recommendation from the Centers for Disease Control and Prevention's advisory panel...is likely to further constrain use of J&J's vaccine...READ MORE

The Biden administration has officially pulled a controversial model that would have tied prices for drugs reimbursed under Part B to prices paid by countries overseas...The Centers for Medicare & Medicaid Services issued a final rule last week that pulls the demonstration approved at the tail end of the Trump administration. Providers had slammed the Most Favored Nation model due to concerns over reimbursement...CMS said in the final rule published on Dec. 29 that the model sparked four lawsuits from the drug industry, which resulted in a legal stay delaying it from going into effect...READ MORE

Attorney General Aaron Ford announced Thursday that Nevada would join a multi-state opiod settlement with drugmakers and distributors...Ford said that the state would receive around $285 million through a pair of settlements...Last year, Ford announced a $45 million settlement against one company involved in the opioid litigation. The lawsuit is being handled on a contingency fee basis for the state by Eglet Prince, the law firm where Ford worked as a private attorney before being elected attorney general in 2018. Ford, however, recused himself from the selection process...Ford in August announced that Nevada would opt out of a $26 billion multi-state settlement...READ MORE

State corrections officials told a federal judge last week that they’re quickly running out time before a crucial lethal injection drug proposed for use in the execution of death row inmate Zane Floyd will expire...Nevada Department of Corrections Director Charles Daniels said in federal court that his chief concern with carrying out the execution is that the necessary drugs would expire before the state could proceed with its execution plan.His testimony followed days of hearings last week, during which medical experts called by the state made the case that the state’s proposed drug cocktail, never before used in carrying out a death sentence, would result in a painless death for Floyd...“My understanding is that it would be less painful than other methods,” said Daniel Buffington, a clinical pharmacologist who works at the University of South Florida. “It would reduce the individual's anxiety… It would be quick.”...
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