Author: Peter

New coronavirus variants have prompted COVID-19 vaccine makers to start developing updates to their existing offerings. To speed their journey to a pandemic-fatigued public, the FDA says it’s developing expedited review rules for the follow-up shots...The FDA’s working on guidance for the types of data needed to support changes to COVID-19 vaccines. The new rules would provide for “streamlined clinical programs” that can demonstrate an immune response to new variants and “can be executed quickly,” FDA’s acting commissioner, Janet Woodcock, said in a statement...READ MORE

McKinsey & Company, the consultant to blue-chip corporations and governments around the world, has agreed to pay nearly $600 million to settle investigations into its role in helping “turbocharge” opioid sales, a rare instance of it being held publicly accountable for its work with clients...The firm has reached a $573 million agreement with attorneys general in 47 states, the District of Columbia and five territories, according to a court filing in Massachusetts on Thursday. Separate deals were announced in Washington State, for $13 million, and in West Virginia, for $10 million...The settlements come after lawsuits unearthed a trove of documents showing how McKinsey worked to drive sales of Purdue Pharma’s OxyContin painkiller...READ MORE

Nevada’s top federal prosecutor said...that his office is expecting a “tidal wave” of CARES Act-related fraud investigations and subsequent prosecutions in the months to come...Congress passed a massive $2 trillion stimulus package last March and included key provisions, such as unemployment insurance benefits and the popular Paycheck Protection Program for struggling businesses...“Businesses were hurting and they still are,” said U.S. Attorney Nicholas Trutanich in an interview with the Review-Journal. Federal relief aid like the PPP, Trutanich said, served as a critical lifeline to keep many Nevada businesses afloat...READ MORE

A new national consortium of virologists has been set up to systematically assess how mutations in SARS-CoV-2 affect key outcomes such as effectiveness of vaccines and therapies, transmissibility of the virus and the severity of COVID-19 infections...Now is the critical time to do this, as the level of both natural and vaccine-conferred immunity that might drive natural selection is increasing, said Wendy Barclay, head of the department of infectious disease at Imperial College London, who is leading the G2P-UK (Genotype to Phenotype-UK) project...“The virus has circulated in humans for more than a year; we’re in a phase where the virus is constantly throwing up new variants and we need to gear up to assess the risk they pose, and to understand the mechanisms by which they act,” Barclay said...READ MORE

With Novavax and Johnson & Johnson data now in hand, the world has efficacy numbers on at least five COVID-19 vaccine programs. That's plenty for analysts to parse—and they're busy doing not only that, but also sizing up the market as the field of top players grows...The upshot? Blockbuster sales to go around, but Pfizer and Moderna will continue to lead the pack, partly thanks to their ability to quickly deploy mRNA against new variants. And for Moderna, at least, that means almost $14 billion in projected sales just this year from one team of analysts...READ MORE

Nevada health officials are sending a message to federal agencies allocating COVID-19 vaccines to states: Show us your math...Questions have dogged state officials since Centers for Disease Control and Prevention data showed Nevada consistently ranking near the bottom of national lists for both receiving vaccine doses and putting shots into arms...Each state’s vaccine allocation is purportedly proportional to its adult population, but officials have offered conflicting information on what year’s population numbers are being used...READ MORE

The data is continuing to come in on the various COVID-19 variants, and so far the news is pretty good. Pfizer and BioNTech announced that their COVID-19 vaccine appears effective against an engineered virus developed with three key mutations found in the South African variant. This was conducted in a laboratory test by Pfizer and the University of Texas Medical Branch...the data has not yet been peer-reviewed, it demonstrated a less than two-fold decrease in antibody titer levels. The bottom line is that the Pfizer-BioNTech vaccine is likely effective in neutralizing the E484K and N501Y mutations found in the South African variant...READ MORE

Scientists gave Russia’s Sputnik V vaccine the green light...saying it was almost 92% effective in fighting COVID-19 based on peer-reviewed late-stage trial results published in The Lancet international medical journal...The results, collated by the Gamaleya Institute in Moscow that developed and tested the vaccine, were in line with efficacy data reported at earlier stages of the trial, which has been running in Moscow since September...READ MORE

Amid a slew of cuts attempting to mitigate projected budget shortfalls in a state largely dependent on tourism and gaming for revenue, state employees are protesting proposed changes that would reduce health care coverage options provided by the state...The proposed cuts in the Nevada Public Employees' Benefits Program budget would reduce life insurance benefits from $25,000 for an active employee to $15,000 and from $12,500 for a retiree to $7,500, eliminate long-term disability insurance and lower Medicare Health Reimbursement Arrangement contributions from $13 to $11 a month per year of service. Though Gov. Steve Sisolak in his State of the State address touted only a 2 percent state budget cut, programs such as PEBP are feeling the cuts more deeply than others...READ MORE

The U.S. Department of Justice is set to recover more than $3 billion this year from pharmaceutical and medical device manufacturers as well as healthcare providers, labs and pharmacies found guilty of healthcare fraud under the False Claims Act. That figure is based upon settlements that were agreed to but not finalized before the end of 2020, and are the direct result of the DoJ’s investigation into the opioid epidemic...READ MORE