About Covid-19
U.S. delivers over 25 mln COVID boosters; Moderna's shot in limited supply “The United States government has sent out over 25 million of the updated COVID-19 booster shots, mostly from Pfizer/BioNTech, as production of the Moderna shot continues to ramp up, a federal health agency said on Tuesday.
Some U.S. pharmacies like CVS Health and Walgreens Boots Alliance also reported on Tuesday that government supply of Moderna’s updated shot remains limited, causing appointments for the product to vary across the country.
Both CVS and Walgreens said they are working with the government to acquire more Moderna doses and have not seen any supply issues for the Pfizer/BioNTech booster.”
Safety of COVID-19 vaccine challenge in patients with immediate adverse reactions to prior doses: A multi-centre cohort study “Severe immediate adverse events following immunization (AEFI) with COVID-19 vaccines have been reported in up to 2.5 per 10,000 vaccinations…
In this cohort study of patients reporting immediate AEFI post-COVID vaccination, 61.2% of the 116 had negative vaccine challenge with a further 34.4% developing mild, subjective symptoms post-vaccination. Thus, 95.6% of the cohort were able to be re-vaccinated safely with 4.3% developing objective signs of a possible immune AEFI, consistent with international experience.”
2 omicron offshoots to keep an eye on “While BA.5 is still the nation's dominant strain, its prevalence has fallen over the past two weeks, according to the CDC's latest estimates.
The subvariant now accounts for 84.8 percent of all U.S. COVID-19 cases — down slightly from 86 percent a week prior, according to estimates for the week ending Sept. 17.
At the same time, the proportion of other omicron offshoots is rising…”
About health insurance/insurers
OIG: Medicare Part B overpaid critical access hospitals and docs for same services “Medicare paid critical access hospitals and providers more than $1 million for duplicate claims in 2019, according to a federal watchdog that called for reforms to detect such errors.
The Department of Health and Human Services’ Office of Inspector General’s (OIG's) report, released Tuesday, called for the Centers for Medicare & Medicaid Services (CMS) to create post-payment reviews of claims.”
Doctor, hospital lobbies move to dismiss lawsuit over surprise billing ban “The American Medical Association and the American Hospital Association are seeking to dismiss their own lawsuit against the federal government over its implementation of The No Surprises Act.
The two lobbying groups filed a motion on Tuesday in federal court seeking to dismiss their claims, along with co-plaintiffs Renown Health, UMass Memorial Health Care and physicians Stuart Squires and Victor Kubit. The motion comes before a status hearing Wednesday.
The groups filed suit over the interim file rule, which was released last year.”
About pharma
Walgreens to acquire remaining stake in Shields Health for $1.37B, announces exec moves “Walgreens Boots Alliance on Tuesday said it will buy the remaining stake in specialty pharmacy company Shields Health Solutions for approximately $1.37 billion.
Walgreens last year spent $970 million to increase its stake in the company to 71%, according to Reuters, with the possibility of taking full ownership over the pharmacy company.
The transaction is expected to be completed by the end of the year.”
In Zantac litigation at state level, drugmakers face claims for cancer types not covered in federal action “Multidistrict litigation is looming for several pharma companies—including GSK, Sanofi, Pfizer, Boehringer Ingelheim and Thermo Fisher—that manufactured and marketed Zantac. The federal litigation targets five types of cancers allegedly caused by consumption of the heartburn medicine.
But now, in state-level litigation, plaintiffs who used Zantac are filing lawsuits that cover other types of cancers, ramping up the concern for the companies already faced with the daunting task of defending themselves in federal court.
In the multidistrict litigation, plaintiffs originally identified 10 cancer types. But that list was pared to five types—bladder, esophageal, gastrointestinal, liver and pancreatic. Many of those who were pared from the multidistrict litigation—including plaintiffs with breast, kidney, colorectal, prostate and lung cancers—are now pursuing their cases in state courts…
Two years ago, Zantac was pulled from the market when it was linked to unacceptable levels of N-nitrosodimethylamine, a potential cancer-causing agent, sparking a wave of litigation.”
The Inflation Reduction Act aims to lower drug costs — but here’s how Big Pharma could get around it “The Inflation Reduction Act is set to lower drug prices for millions of people in the U.S. — but experts fear pharmaceutical companies could exploit loopholes in the bill, ultimately keeping prescription costs high for many.
The law takes aim at insulin costs, caps out-of-pocket spending for Medicare beneficiaries, and allows the federal government to negotiate prices on the costliest prescription drugs. It also will require drugmakers to pay a rebate to Medicare if they raise prices too sharply.
These provisions won’t be implemented all at once. Instead, they’ll go into effect gradually over the next several years, beginning with insulin price caps and rebates in 2023, out-of-pocket caps in 2025, and finally drug negotiations in 2026.
Because of the four-year gap before the law is fully implemented, policy and legal experts fear that pharmaceutical companies may have ample time to go on the offense and — if they don’t try to get the law thrown out in court — figure out ways to sidestep provisions that affect their ability to maintain their high profits.”
Current and Resolved Drug Shortages and Discontinuations Reported to FDA Some examples: Cefazolin Injection, Dextrose injections (several concentrations), Diltiazem injection, Furosemide injection, and 119 more.