- Nearly 4K people may have gotten slightly lower Pfizer COVID-19 dose at a Kaiser Permanente location (fiercehealthcare.com)
Nearly 4,000 people may have received a slightly less than recommended dose of the Pfizer COVID-19 vaccine at a Kaiser Permanente location in California last year. The health system is offering repeat vaccinations to anyone affected...The vaccinations were given at the Kaiser Permanente Walnut Creek Medical Center...Individuals may have received between 0.01 and 0.04 milliliters less than the correct 0.3-ml dose. The health system reportedly said the incident was a misunderstanding among staff, which it has retrained, and is contacting patients about the error...READ MORE
- Nevada enlisting nursing students for hospital staff crisis (apnews.com)
With Nevada hospitals reporting a staffing “crisis” and health officials reporting COVID-19 patient tallies at pandemic highs, Nevada Gov. Steve Sisolak highlighted a program...to enlist nursing students to help meet the demand for medical providers...“The state continues to work with all of our partners to leverage existing resources and break down barriers so Nevadans in need can access care,” the governor...said on a day that health officials reported what Dr. John Hess, a University of Nevada School of Medicine associate faculty member, called a “challenging time” with case counts “incredibly high right now.”...READ MORE
- Elizabeth Holmes: Theranos fraudster to avoid sentencing for at least eight months (unitednewspost.com)Theranos founder Elizabeth Holmes convicted on 4 counts of fraud (abcnews.go.com)
Elizabeth Holmes, the Theranos founder convicted of four counts of felony criminal fraud by a jury earlier this month, probably will not receive her sentence until after Labor Day...The filing describes the reason for the delay as related to “ongoing proceedings in a related matter.” The federal fraud trial of Holmes’ co-accused, former Theranos chief operating officer Sunny Balwani, is expected to start in March...She is free on a $500,000 bond secured by her signature, but the filing said her lawyers have agreed with the prosecution to have the bond secured by property...READ MORE
- CMS pulls Trump-era Most Favored Nation drug price model (fiercehealthcare.com)
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
- Judge Grants Stay in Federal Case Against Pharmacy DIR Fees Until Proposed Rule Finalized (ncpa.org)APhA, others file federal lawsuit against HHS to close DIR loophole (pharmacytoday.org)
The National Community Pharmacists Association and the American Pharmacists Association... issued the following statement in response to a decision by the U.S. District Court for the District of Columbia to grant a stay the case, NCPA v. Becerra, which challenges the legality of retroactive pharmacy price concessions, also known as pharmacy direct and indirect remuneration fees:...“We are pleased by the court’s decision to grant our request for a stay, or a pause in the litigation, until the recently proposed rule potentially addressing retroactive pharmacy DIR fees is finalized. We are currently analyzing the proposed rule to determine whether it addresses our longstanding concerns with retroactive pharmacy DIR fees, and we plan to submit comments reflecting our analysis. Since our litigation also seeks to end retroactive pharmacy DIR fees, we believe, and the court agreed, that a pause in the case is appropriate pending the outcome of the rulemaking process.”
- GlaxoSmithKline rushes to accelerate COVID-19 antibody output amid omicron-driven demand (fiercepharma.com)
GlaxoSmithKline and Vir Biotechnology are rushing to speed up production of their COVID-19 therapy, now that they're the only companies with an antibody that appears to be truly effective against omicron...The FDA...cleared a Samsung Biologics site as a second manufacturing facility to make GSK and Vir’s Xevudy (sotrovimab)...Along with adding the new facility, GSK and Vir worked with external partners to secure additional batches of drug substance to support supply this year...READ MORE
- Judge: FDA Cannot Have Until 2076 to Disclose Pfizer/BioNTech Vaccine Data (biospace.com)
...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
- COVID vaccines help Pfizer, Moderna reign supreme reputation-wise, but they’re a double-edged sword for J&J and AZ (fiercepharma.com)
Pfizer and Moderna are now two of the leading pharma companies in the U.S. when it comes to public image, thanks to their COVID vaccines. On the flip side, vaccine rivals J&J and AstraZeneca have seen their reputations plummet...This is according to a new survey by market research firm Leger, which looked into how the pharma industry’s reputation has changed during COVID and the creation of new vaccines against the disease...READ MORE
- Free prescriptions on Universal Credit: Are you eligible for free NHS medicine on UC? (unitednewspost.com)
Millions of Britons in England may soon be charged for their medication, as the Government plans to raise the qualifying age for free NHS prescriptions to 66, in line with the state pension age. But what does this mean for others entitled to free prescriptions? And can you get free prescriptions if you receive Universal Credit?...Most treatments on the NHS are free, but notable exceptions include paying for prescriptions...Most Britons have to pay for their prescriptions, but there are exceptions including those for people of certain ages, people receiving benefits and pregnant women...Anyone aged under 16, between 16 and 18 but in full-time education, or over 60 is automatically eligible for free prescriptions...For older people, the Government is planning to raise the qualifying age for free prescription from 60 to 66, which could come into force as early as April 2022...READ MORE
- Nevada hospitals request state aid as virus strains staffing (apnews.com)
Hospitals throughout Nevada are facing twin challenges as beds fill with COVID-19 patients and staff falls ill from the highly contagious omicron variant...“Nevada is experiencing an abrupt increase in COVID-19 hospitalizations, predominantly in the southern region following the holidays. People are flocking to hospital emergency departments seeking COVID-19 testing, compounding the staffing problem,” they said, describing the second week of January...“Hospitals are not over-run by a COVID-19 surge as much as being understaffed as employees in all fields report being sick and unable to work. This is also further compounded by a significant increase in people coming to the emergency department solely for testing. Hospitals are not testing sites,” the Nevada Hospital Association said...READ MORE